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omc-juniperpublishers · 4 years ago

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Quality by Design in Enzyme Catalyzed Reactions-JuniperPublishers

Journal of Chemistry-JuniperPublishers

Abstract

Quality by Design is the new-age path chosen towards achieving the demanding quality standards in pharmaceutical industry. The present paper aims to throw light on Pharmaceutical Quality byDesign (QbD) and how its implementation will help manufacture better quality of Pharmaceuticals. Quality by Design is introduced along with its key elements to help make the understanding process easier. To attain built-in quality is the primary objective of Quality by Design. Finally, it can be said that the quality that is achieved by end product testing is not something that can be guaranteed unlike the quality assurance that can be provided by Quality by Design.

Keywords: Quality by Design (QbD); Quality Target Product Profile; Design Space; Critical Quality Attributes

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Introduction

“Quality Can Be Planned.”-Joseph Juran

The above quote is self-explanatory when it comes to product quality in the pharmaceutical manufacturing industry. Quality by design (QbD) is not very old but a recent inclusion in the pharmaceutical industry. It`s sole objective is to achieve better quality standards that is especially important in the pharmaceutical industry. The QbD approach consists of various components, important ones being risk assessment, assessment and management of the identified risks, design of experiments (DoE), quality target product profile (QTPP), and establishing a control strategy to keep the product within the design space that was created with the QbD study [1]. Out of all the components, a lot of pharmaceutical development studies have incorporated DoE for a more rational approach [2].

The target of analytical QbD approach is to establish a design space (DS) of critical process parameters (CPPs) where the critical quality attributes (CQAs) of the method have been assured to fulfil the desired requirements with a selected probability [3-4].

The principles that are involved in the pharmaceutical development and are relevant to QbD are all described in the ICH guidelines (ICHQ8-11) [5].

Any Pharmaceutical Development Process Typically Covers the Following Sections:

a) Complete portfolio including all the details as well as analysis of the Reference Listed Drug Product

b) Quality Target Product Profile (QTTP) compilation.

c) Figuring out the Critical Quality Attributes (CQA)

d) Complete characterization of API &CMA (Components of Drug product) identification of the API

e) Excipient selection& excipients CMA identification

f) Formulation Development

g) Manufacturing Process Development [6]

Quality Target Product Profile (QTPP) describes the design criteria for the product, and should therefore form the basis for development of the CQAs, CPPs, and control strategy.

Critical Quality Attributes (CQA) – A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality (ICH Q8) Critical Process Parameter (CPP) – A process parameter whose variability has an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality. (ICH Q8) Critical Process Parameters (CPP) identification and their impact analysis is done by conducting a preliminary risk analysis for every process parameter (PP) that is involved in the individual unit operations.

Need for QbD in Pharmaceutical Industry [7,8]:

a) To integratepatient needs, quality requirements and scientific knowledge all in one design while the pharmaceutical product is still under developmentand further extending to the manufacturing process.

b) To have a better understanding about the impact of raw materials and process parameters on the quality of the final product. This is especially important for biopharmaceutical products since raw materials like cell culture media can be the risk for variability, effecting important factors likecellular viability, cell growth and specific productivity.

c) To collaborate closely with rest of the industries and the regulators and successfully keep up with the regulatory reviews

d) To maintain harmonization in all the regions so that a single CMC submission worldwide is all that is needed.

e) To encourage continuous quality improvement for the benefit of patients.

f) To enable better product design that will have less problems while manufacturing, thus facilitating more efficiency in the manufacturing process.

g) To make post-approval changes easier since it will be contained within a pre-defined design space, thus resulting in regulatory flexibility.

Every production process in a pharmaceutical industry to implement certain control strategies with the ultimate goal of a robust process. A robust process is the gateway to high product quality at the end of the day [9]. Process variability stands as a hurdle to process robustness, and this originates from lack of control on the process parameters. Thus, QbD steps-in to avoidbatch to batch variability in pharmaceutical products [10].

The net outcome of the detailed QbD study (applied in any product) is the segregation of process parameters with respect to their criticality and the finalization of a proven acceptable range (PAR) for every operation. The knowledge that is gained post the QbD evaluation encompasses every minute detail of the operational process as well as the product in general, and lead to the defining of a Design Space. This way, the impact that the manufacturing process might have with regard to the variability of the CQAs becomes apparent, which helps in strategizing testing, quality and monitoring of batches [11].

Process Evaluation: Linking Process Parameters to Quality Attributes

It is important to carefully evaluate the process completely before applying QbD to it. The better knowledge you have of the process, the more effective your QbD will be. Moreover, process characterization is required to specify the proven acceptable ranges (PAR) for critical process parameters (CPPs). In the traditional approach that is implemented in biopharmaceutical production, existing empirical process knowledge is used on a daily basis. However, this approach leads tolaborious and time consuming post approval changes during process adaptation and any new technology implementation that may have become necessary for raising the efficiency of the process. Also, the effects aprocess scale-up can have on the quality of the final product cannot be predicted when using the empirical process development.

This can increase costs and also can cause difficulty in implementing any changes in the set manufacturing process. Thus was born a way to achieve deeper understanding of processes which would lead to greater flexibility and freedom to effect changes. The concept of operation under a pre-defined design space gave this flexibility. Design space is nothing but a concept that is a part of the “Quality by Design” (QbD) paradigm. Now, manufacturers are to follow a science-based process development than their empirical counterpart.

The QbD Concept is Best Explained in this Flowchart Below

Define a Quality Target Product Profile (QTPP) for product performance

⇩

Identify its Critical Quality Attributes (CQAs)

⇩

Create experimental design (DoE)

⇩

Analysis done to understand the impact of Critical Process Parameters (CPP) on CQAs

⇩

Identify and control the sources of variability.

Process characterization sets the ball rolling in any process development, which employs a sound risk assessment rating the various critical process parameters according to their importance [12-14].

Downstream Processing in Biotransformation

Downstream processes of biopharmaceutical industry essentially include the following steps:

a) Harvesting

b) Isolation

c) Purification

Various unit operations that constitute any biopharmaceutical process follow a designed sequence to form an integrated process [15]. Thus, any change in any one of the one-unit operation can affect the functioning of the subsequent unit operations. This is the reason why interaction effects between participating parameters across unit operations should also be taken into account during the process development. Interactions are said to happen when setting of a parameter will show effect on the response of another parameter. Due to this dependence between the parameters, the combined effects of any two parameters hailing from different unit operations cannot be predicted from their individual effects. Regulatory authorities demand inclusion of interactions of parameters within the QbD approach during any process optimization [16]

Example: Downstream processing of 1, 3-propanediol

Process: Fermentation

Fermentation broth that uses flocculation, reactive extraction, and distillation was studied. Flocculation of soluble protein as well as cellular debris that were present in the broth was carried out by using optimal concentrations of chitosan (150 ppm) and polyacrylamide (70 ppm). It was seen that the soluble protein that was present in the broth decreased to 0.06 g L-1. Recovery ratio (supernatant liquor: broth was found to be greater than 99% (Figure 1) [17,18].

The above flowchart shows a typical fermentation process broken down in steps. Glycerol fermentation process is taken as example for the illustration [19].

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Case Study for API

API product development from the very nascent stages require a lot of planning when implementing QbD at every stage. Whether it is two-step process or a multi-step process, each and every operation and parameter needs to be scrutinized before creating a relevant design space. Brainstorming every possible roadblock that might threaten the quality of the final pharma product is what will help design a top-quality process. A futuristic vision is important in the initial steps of QbD planning. The most important part is to pay sufficient attention to detail lest critical aspects might be missed. This is best done by sitting with the entire development team and taking every minor detail into account. Given below is a case study for a API intermediate development process with the help of QbD that highlights the important steps as to how to go about implementing it from the very beginning of your research. QbD is done best, when it is implemented from the very nascent stage of product development.

Quality Target Product Profile

When making your QTPP, make sure you list down everything from your vendor details to target costing. This step basically asks you to think of every aspect of your product and make a comprehensive profile of it. The specification of quality must be highlighted here with all the challenging impurities that might threaten your quality. Everything from stability testing requirements to raw material quality [20] is encompassed in this stage of QbD.

CQA Determination

Given below are some typical CQA parameters that are considered in most of the enzymatic methods of API intermediate preparations.

a) Purity

b) Chiral purity

c) Enzyme residue

d) Assay

e) Appearance

f) Residual Solvent

g) Yield

h) Polymorphic forms

i) Moisture content

j) Melting point (Table 1)

Initial Risk Assessment

The risk assessment can be done in various ways and is the customizable step in QbD. This part calls for a group-discussion or a team meeting where everyone can list down all possible risks related to the project in discussion and grade each one in the list with the amount of risk that it poses. The simplest module suggests you number them 1, 2, 3 with the increasing or decreasing order of the risk threat. A more complicated and detailed risk assessment requires linking of CQAs and CPAs to highlight the risk of their interdependence (Figure 2) [21].

Post risk assessment, comes the control strategies to be followed to tackle the possible risks that are probable. The control strategies are for you to think and execute to achieve your target quality specifications.

Design of Experiment

This is a valuable tool for channelizing your experimental work, to move ahead in a systematic manner. Design of experiments can be of several types: comparative, screening, response surface modeling, and regression modeling [1].

Comparative Experiments: The aim of this study is simple, i.e., picking best out of two options. The selection can be done by the comparison data generated, which is the average of the sample of data.

Screening Experiments: If you want to zero-in on key factors affecting a response, screening experiments would be the best bet. For this, list down concise list of factors that might have critical effects on response that you desire. This model serves as preliminary analysis during development studies.

Response Surface Modeling: Once you have identified the critical factors that affect your desired response, response surface modeling comes handy to identify a target and/or minimize or maximize a response.

Regression Modeling: This is used to estimate the dependence of a response variable on the process inputs.

A step by step guide is given for the DoE step of the QbD process (Figure 3).

Response columns were filled post experimentation as per the design creation (Figure 4).

Factorial Design Analysis Done as Given Under

Analysis Done First for One of the Responses, “Yield”: (Table 2)

P-Values Were Checked for Significance and Higher P-Value Term Eliminated First to Create a Reduced Model:

(Table 3) (Figures 5 & 6)

Observation

From the above graph, significant interaction between the two terms can be inferred.

Analysis Done for the Response “Diacid”: (Table 4)

P-values Checked for Significance and Higher P-Value Term Eliminated First to Create a Reduced Model: (Table 5) (Figure 7)

Observation

From the above graph, significant interaction between the two terms can be inferred.

Response Optimizer Was Used to Optimize Both The Terms With Respective to The Given Responses- Yield and Diacid: (Table 6) (Figure 8)

The optimized parameters predicted for maximum yield and minimum impurity (of di-acid) was found to be 8pH and 37C.

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Case Study 2

As mentioned before, regression analysis is another important tool that can be used to study existing data. This means that if you have done some experiments (without designing them beforehand), you can quickly run a regression analysis of the collected data to derive a relationship between CPPs and the reaction results.

A lot of times, when one follows the one-factor-at-a-time optimization process, by the time any CPP is optimized, a lot of data stands generated. Instead of just tabulating the data and wasting time manually making sense out of them, regression analysis can come to your rescue. As always, graphical data representation seems much easier to understand and also saves your valuable time.

The effect of pH was studied [22] separately in the preparation of deoxynojirimycin base (stage III). The reaction involved N-formyl amino sorbitol, water, oxygen and whole cells of Gluconobacter oxydans DSM2003. Later involvement of sodium hydroxide and sodium borohydride gave rise to deoxynojirimycin. Further work-up and 2-methoxy ethanol facilitated crystallization yielded Deoxynojirimycin base. In this experiment, pH of the reaction was changed to find out its role during the reaction and a regression analysis was run using Minitab to study this affect.

Observations recorded showed that reaction did not occur at pH2 and at pH8, the reaction did not reach completion. The optimum pH range between 4 to 6 showed certain effect on yield and purity. The significance of pH variation during the reaction was thus established as described below (Graphs 1-3):

When null hypothesis p-test was carried out, no significant effect of pH was to be found on product purity, impurity1 and impurity2, but its significant influence was seen in minimizing impurity3.

Furthermore, large-scale batches conducted were statistically analyzed as well to achieve better understanding of the influence of list of parameters on the output obtained. The following parameters were studied during the stage III reaction described above:

a) pH, RPM and Oxygen cylinders consumed during the course of the reaction.

Their effect on the output and reaction completion time was studied. It was seen that only RPM showed statistically significant effect on the reaction completion time and rest of the factors did not contribute to any significant effect on the output or reaction completion time.

During biotransformation process, i.e. during oxidation of N-formyl using Gluconobacter oxydans DSM2003 whole cell, three main unknown impurities peaks were observed in HPLC chromatogram while reaction monitoring. This process is capable of removing these three impurities during down streaming, work up & isolation to the levels mentioned below:

a) Impurity 1 (has defined RRT on HPLC chromatogram) not more than 3%

b) Impurity 2 (any other unknown impurity) not more than 1%

c) Impurity 3 (has defined RRT on HPLC chromatogram) not more than 10 %

Since higher level of impurities affect the yield of the process, efforts were carried out to study the factors which can reduce the formation of process impurities.

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Conclusion

The concept of Quality by Design (QbD) is highly reliable when it comes to achieving foolproof quality of your product. This is a modern tool that is going viral in Pharmaceutical industry especially because this industry demands high quality standards and tolerates no compromise when it comes to the quality. Breaking down QbD, it essentially comes down to identifying the critical parameters of the process and assigning a particular design space for every single critical attribute. Thus, QbD can be considered as an intelligent approach to quality that yields robust processes. QbD also ensures that there is continuous improvement in the process during the entire lifecycle of a Pharmaceutical product [23].

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Acknowledgement

Our group would like to thank the Department of Scientific and Industrial Research India, Dr. Hari Babu (COO Mylan), Sanjeev Sethi (Chief Scientific Office Mylan Inc); Dr. Abhijit Deshmukh (Head of Global OSD Scientific Affairs); Dr. Yasir Rawjee {Head - Global API}, Dr. Sureshbabu Jayachandra (Head of Chemical Research); Dr. Suryanarayana Mulukutla (Head Analytical Dept MLL API R & D) as well as analytical development team of Mylan Laboratories Limited for their encouragement and support. We would also like to thank Dr. Narahari Ambati (AGC- India IP) & his Intellectual property team for their support.

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marketresearchblogimr · 3 years ago

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2-Methyl-1 3-Propanediol Market Development and Trends

According to this latest study, the growth in the 2-Methyl-1 3-Propanediol market will change significantly from the previous year. Over the next five years, 2-Methyl-1 3-Propanediol will register a CAGR in terms of revenue, and the global market size will reach USD in millions by 2028.

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Assay (on a dry basis), Water, Color, Carbonyl (as -CHO), Iron

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Unsaturated Polyester Resins, Coating, Modified PET, Personal Care

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imrmarket · 3 years ago

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2-Methyl-1 3-Propanediol Market 2021: Future Demand, Market Analysis

2-Methyl-2-propyl-1,3-propanediol (MPP) is a simple alkyl diol which has sedative, anticonvulsant and muscle relaxant effects. It is both a synthetic precursor to, and an active metabolite of the tranquilizers meprobamate and carisoprodol, as well as other derivatives. Methyl-propane-diol, also known as MPD, is an organic compound with the chemical formula CH₃OCH₂CH(OH)CH₃. It is a clear, colorless liquid with a faint odor. MPD is miscible with water and soluble in most organic solvents. MPD is produced by the hydrogenation of propionaldehyde. It is used as a building block for the production of polyurethanes, resins, and plasticizers. MPD can also be used as an antifreeze, coolant, and heat-transfer fluid.

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· Europe (Germany, U.K., France, Italy, Russia, Spain, Rest of Europe)

· Asia-Pacific (China, India, Japan, Southeast Asia, Rest of APAC)

· Middle East & Africa (GCC Countries, South Africa, Rest of MEA)

· South America (Brazil, Argentina, Rest of South America)

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tejasamale · 3 years ago

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1,3-Propanediol Market Segment: Research, Size, Share, Trends, Demand, Key Player profile and Regional Outlook by 2027

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thetejasamale · 3 years ago

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1,3-Propanediol Industry: Regional Outlook, Size, Share, Trends, Demand and Key Player profile by 2027

The growing demand for 1, 3-propanediol from various applications is expected to drive the growth of the market during the review period. The major applications of 1, 3-propanediol are polytrimethylene terephthalate, polyurethane, cosmetics & personal care, household, engine coolants among others. The growing development of cosmetic & personal care industry across the globe is expected to boost the market during the forecast years. Moreover, the growing investment in research and development activities for the production of bio-based 1,3 propanediol is anticipated to be a major opportunity in the market.

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Market Segmentation

The global 13 propanediol market is segmented into application and region.

On the basis of application, the global market of 1, 3-propanediol can be further segmented into polytrimethylene terephthalate, polyurethane, cosmetic & personal care, household, engine coolants, heat transfer fluid, de-icing fluid and others. On the basis of region, the global 1, 3-propanediol market is bifurcated into Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa.

Market Scenario

Among the various applications of the 1, 3-propanediol, the polytrimethylene terephthalate segment was anticipated to be the dominant segment in 2016 and is expected to show the same trend during the forecast years. The polyurethane segment is expected to witness the highest growth with a CAGR of over 4.5% during the assessed period. The growing demand for polytrimethylene terephthalate across various applications such as cosmetic & personal care, engine coolants, and de-icing fluid among other is substantially contributing to the growth of the segment.

The global 1, 3-propanediolmarket is spanned across five key regions: Europe, Asia Pacific, North America Latin America, and the Middle East & Africa. Among these, Asia Pacific is the fastest growing market during the forecast period. The growing population has increased the demand for cosmetics & personal care and household products, in turn, adding to the demand for 1,3 propanediol market. North America followed by Europe is anticipated to be the largest markets during the given period. The developed automobile, cosmetic & personal care industry along with the growing shift towards biodiesel is positively contributing to the growth of the market.

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Competitive Analysis

DuPont Tate & Lyle Bio Products Company, LLC (U.S.), Metabolic Explorer SA (France) Zhangjiagang Glory Biomaterial Co. Ltd (China) and Zouping Mingxing Chemical Co., Ltd (China), Royal Dutch Shell (Netherland), Shanghai Jinjinle Industry Co., Ltd (China), Zouping Mingxing Chemical Co.,Ltd (China), Salicylates And Chemicals Pvt. Ltd (India), and Chongqing Kunlun Chemical Co., Ltd (China) among others.

#13-Propanediol Industry

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dineshkarde103 · 4 years ago

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#Meat Processing Equipment Market Size

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shraddha0330 · 4 years ago

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Global 1,3-Propanediol (PDO) Market To Reach A New Threshold of Growth By 2025

Market Overview

The Global 1,3-Propanediol (PDO) Market is foreseen to experience a fall from USD XX billion in 2020 to USD XX billion in 2021 at a CAGR of XX%. The descent is primarily the result of economic decline across countries unsettled due to ongoing Coronavirus outbreak, including controlling it. Thereafter, the 1,3-Propanediol (PDO) market is likely to restore and expand at a CAGR of XX% from 2021, stretching up to USD XXX billion in 2025.

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The research document comprises market traits, opportunities, industry size, fragmentation, territorial breakdowns, market shares, ongoing trends, competitive landscape, and strategies for the 1,3-Propanediol (PDO) market. The report also tracks essential information about the market and predict market expansion by the geographic landscape. It also positions the market under the extensive 1,3-Propanediol (PDO) market framework and collates it with other alternative markets.

This report also offers the planners, policymakers, senior leadership, and traders crucial details to estimate the global 1,3-Propanediol (PDO) market as it arises from the COVID-19 closure.

Market Scope

The 1,3-Propanediol (PDO) Industry sets out tendencies that affect various subsidiary industries. Therefore, the Global market has ruled for being one of the leading revenue generators over the past several decades. This industry has challenged every economic disruption and withstands the test of time. Though this could benefit to motivate new market players in the Global industry, the preference for product development and novel procedures could assist new participants in obtaining a stronghold.

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1,3-Propanediol (PDO) Market Research Report is Segmented as Follows:

Product Types can be segregated as:

Technical Grade

Pharmaceutical Grade

Other

Applications can be segregated as:

PTT

Pharmaceutical

Cosmetics

Others

Regions covered in this report are:

North America

United States

Canada

Europe

Germany

France

U.K.

Italy

Russia

Nordic

Rest of Europe

Asia-Pacific

China

Japan

South Korea

Southeast Asia

India

Australia

Rest of Asia-Pacific

Latin America

Mexico

Brazil

Middle East & Africa

Turkey

Saudi Arabia

UAE

Rest of Middle East & Africa

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Global 1,3-Propanediol (PDO) Market Report provide in-depth information about the Leading Competitors involved in this report:

DuPont

Metabolic-Explorer

Glory Biomaterial

Shangdong Mingxing

Chenneng

Henan Tianguan

Shanghai Demao

DOW

Innovations in the technology field have contributed to the growth of the Global industry. The arrival of energy- and cost-efficient appliances have rejuvenated procedures in the 1,3-Propanediol (PDO) industry.

Economic expansion in developing countries as well have arisen as an advantage for the Global industry. Although strict rules that supervise global production and processing affect the growth rate of the Global industry.

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#13-Propanediol (PDO) Market size

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pooja1234 · 4 years ago

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Global 1,2-Propanediol Market Revenue Poised for Significant Growth During the Forecast Period of 2021-2025

Market Overview The Global 1,2-Propanediol Market is foreseen to experience a fall from USD XX billion in 2020 to USD XX billion in 2021 at a CAGR of XX%. The descent is primarily the result of economic decline across countries unsettled due to ongoing Coronavirus outbreak, including controlling it. Thereafter, the 1,2-Propanediol market is likely to restore and expand at a CAGR of XX% from 2021, stretching up to USD XXX billion in 2024. BUY ANY 3 AND PAY FOR ONLY 2 Hurry Up To Grab This Exciting Offer…………! This Discount offer is valid till 31st March 2021 Get Free Sample Report @ https://ordientmarketresearch.com/sample-request/chemicals-and-materials/world-1-2-propanediol-market/OMR2156 The research document comprises market traits, opportunities, industry size, fragmentation, territorial breakdowns, market shares, ongoing trends, competitive landscape, and strategies for the 1,2-Propanediol market. The report also tracks essential information about the market and predict market expansion by the geographic landscape. It also positions the market under the extensive 1,2-Propanediol market framework and collates it with other alternative markets. This report also offers the planners, policymakers, senior leadership, and traders crucial details to estimate the global 1,2-Propanediol market as it arises from the COVID-19 closure. Market Scope The 1,2-Propanediol Industry sets out tendencies that affect various subsidiary industries. Therefore, the Global market has ruled for being one of the leading revenue generators over the past several decades. This industry has challenged every economic disruption and withstands the test of time. Though this could benefit to motivate new market players in the Global industry, the preference for product development and novel procedures could assist new participants in obtaining a stronghold. Browse Full Premium Report @ https://ordientmarketresearch.com/chemicals-and-materials/world-1-2-propanediol-market/OMR2156 1,2-Propanediol Market Research Report is Segmented as Follows: Product Types can be segregated as: Industrial Grade Food Grade Pharmaceutical Grade Applications can be segregated as: Unsaturated Polyester Resins (UPR) Functional Fluids Cosmetics Pharmaceutics and Food Liquid Detergents Others Regions covered in this report are: North America United States Canada Europe Germany France U.K. Italy Russia Nordic Rest of Europe Asia-Pacific China Japan South Korea Southeast Asia India Australia Rest of Asia-Pacific Latin America Mexico Brazil Middle East & Africa Turkey Saudi Arabia UAE Rest of Middle East & Africa Checkout Inquiry For Buying or Customization of 1,2-Propanediol Market: https://ordientmarketresearch.com/enquiry/chemicals-and-materials/world-1-2-propanediol-market/OMR2156 Global 1,2-Propanediol Market Report provide in-depth information about the Leading Competitors involved in this report: Dow Lyondell Basell INEOS BASF ADM Sumitomo Chemical (Nihon Oxirane) SKC Repsol Asahi Kasei Huntsman Shell Tongling Jintai Chemical Shandong Shida Shenghua Chemical CNOOC and Shell Petrochemicals Hi-tech Spring Chemical Daze Group Shandong Depu Chemical Innovations in the technology field have contributed to the growth of the Global industry. The arrival of energy- and cost-efficient appliances have rejuvenated procedures in the 1,2-Propanediol industry. Economic expansion in developing countries as well have arisen as an advantage for the Global industry. Although strict rules that supervise global production and processing affect the growth rate of the Global industry. Enquire about Discount for This Report @ https://ordientmarketresearch.com/check-discount/chemicals-and-materials/world-1-2-propanediol-market/OMR2156 Reasons to buy this report: Obtain a genuinely global viewpoint along with the most extensive report obtainable on the 1,2-Propanediol market, including more than 50 ecologies. Develop regional and territorial schemes depending on local data and research. Recognize customers and clients based on the most recent ma

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newinnovationalmarketresearch · 4 years ago

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1,3-Propanediol Market Evaluation, Competition Tracking & Regional Analysis: (2021-2025)

As per the report published by the experts; the global 1,3-Propanediol (PDO) Market is estimated to reach US$ 776.3 million by 2022 with a CAGR of 5.8% during the forecast period. Increasing demand for polyesters for example Polytrimethylene Terephthalate (PTT) and growing infiltration of polyurethane through a number of end-use businesses are likely to be important motivating issues for global 1,3-Propanediol industry. Increasing uses of polyester through various businesses are expected to help more for the development.

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Key Players:

- Zouping Mingxing Chemical Co., Ltd., Metabolic Explorer, Shell Chemicals LP, Zhangjiagang Glory Biomaterial Co. Ltd

Growth Drivers:

The manufacturing of 1,3-Propanediol (PDO) can be done equally from both the sources, such as petrochemical based and bio-based. Glycerol has been attaining importance as the most important raw material for the production of 1,3-Propanediol (PDO). Glycerol is manufactured from a by-product resulting out of biodiesel. Growing production of biodiesel is likewise projected to take an optimistic effect on the development of the market. A stable move in the direction of decreasing dependence on petroleum products because of increasing concerns about the environment and instability related to their pricing has encouraged the demand for biodiesel. Consecutively, this is estimated to surely influence on the development of the 1,3-Propanediol market.

Global 1,3-Propanediol (PDO) Application Outlook (Volume, Kilo Tons; Revenue, USD Million, 2012 - 2022)

• Polytrimethylene Terephthalate (PTT)

• Polyurethane (PU)

• Personal Care & Detergents

• Others

The global 1,3-PDO market can be classified by Application and Region. By Application it can be classified as Detergents & Personal Care, Polytrimethylene Terephthalate (PTT), Polyurethane (PU), and others.

Regional Lookout:

By Region the global 1,3-PDO industry can be classified as North America, Europe, Asia Pacific, Central & South America, and Middle East & Africa. North America ruled the global market for 1,3-Propanediol (PDO) with respect to estimation of the market and demand. The region was responsible for the maximum share of the global consumption during the historical year. Developing nations of Central & South America and Asia Pacific are supposed to experience the uppermost percentage of development during the period of forecast. The economies for example Argentina, Brazil, India and China are projected to lead the development of the provincial market. The economies like Argentina, Brazil, Russia, and China are taking dedicated footsteps to decrease their necessity of fossil fuel and inspire the manufacture of biodiesel. Encouraging directives or rules about biodiesel in these nations are expected to pay to the greater manufacture of glycerol and consecutively, support in the development.

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globalmarketreports · 4 years ago

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1, 3-Propanediol (PDO) Market Size, Demand, Analysis and Forecast Report to 2027

Latest published report on the 1, 3-propanediol (PDO) market, found on the Qualiket Research website revealed a great deal about various market dynamics. These driving factors influence the market from a very miniscule level to its holistic standard and can traverse limitations to assist the market achieve a significant growth rate over the analysis period of 2020-2027.

Request Sample Copy of this Report @ https://qualiketresearch.com/request-sample/1-3-propanediol-PDO-Market/request-sample

1, 3-propanediol (PDO) is an organic chemical compound that is utilized on large scale for number of a number of industrial productions and research applications as it provides various benefits to end users. It is produced organically from glycerol and its interactions with microorganism in anaerobic conditions.

Market Drivers

Increase in polyurethane penetration across various end use industries is the key driving factor which is expected to boost the global 1,3-propanediol (PDO) market growth. Furthermore, increase in demand for eco friendly and bio based products will have the positive impact on market growth. Moreover, increase in usage of 1,3-propanediol (PDO) in resin application will propel the market growth. In addition to that, increase in research and development activities to develop bio based products will fuel the market growth.

Market Restraints

However, availability of substitutes with comparatively low cost is the major challenging factor which is expected to hamper the global 1, 3 propanediol (PDO) market growth. Lack of awareness will affect the market growth.

Market Key Players

Various key players are discussed in this report such as Dupont Tate & Lyle Bio Products Company, Llc, Zhangjiagang Glory Biomaterial Co., Ltd., Zouping Mingxing Chemical Co., Ltd., Haihang Industry Co., Ltd., Hunan Rivers Bioengineering Co., Ltd., Merck KGgA, Tokyo Chemical Industry Co., Ltd. and Zhangjiagang Huamei Biomaterial Co., Ltd.

Market Taxonomy

By Type

Bio-Based PDO

Petrochemical-Based PDO

By Application

Polytrimethylene Terephthalate (PTT)

Polyurethane

Personal Care

Others

By End User

Synthetic Drugs

Engineering Plastics

Textile Dyeing & Finishing

Others

By Region

North America

Latin America

Europe

Asia Pacific

Middle East & Africa

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tejasamale · 4 years ago

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1,3-Propanediol Market Research: Trends, Demand, Growth and Size by 2027

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thetejasamale · 4 years ago

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1,3-Propanediol Market: Size, Segments, Growth, Trends, Demand, Key Player profile and Regional Outlook by 2023

Get a Free Sample Now@ https://www.marketresearchfuture.com/sample_request/5722

Market Segmentation

The global 13 propanediol market is segmented into application and region. On the basis of application, the global market of 1, 3-propanediol can be further segmented into polytrimethylene terephthalate, polyurethane, cosmetic & personal care, household, engine coolants, heat transfer fluid, de-icing fluid and others. On the basis of region, the global 1, 3-propanediol market is bifurcated into Asia Pacific, North America, Latin America, Europe, and the Middle East & Africa.

Market Scenario

Access Report Details @ https://www.marketresearchfuture.com/reports/1-3-propanediol-market-5722

Competitive Analysis

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worldwidenewstrending · 4 years ago

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Styrene Butadiene Rubber Market to Grow 8.78 $ billion by 2027 | Korea Kumho Petrochemical Company, LCY Chemicals, Versalis, Styron-Trinseo, Synthos, Zeon Corporation,

Styrene Butadiene Rubber Market report have provided in-depth information on leading growth restraints, drivers, challenges, share, trends, application and opportunities to offer a complete analysis of the global Sustainable Packaging market. By Few of the major competitors Lanxess, Sinopec, The Goodyear Tire & Rubber Company, Michelin, JSR Corporation, Eastman, SIBUR, LG Chemicals, Dynasol Elastomer, Korea Kumho Petrochemical Company, LCY Chemicals, Versalis, Asahi Kasei Chemical Corporation, Styron-Trinseo, Synthos, Zeon Corporation, Shenhua Chemical Industrial Co. Ltd., Eastwest Copolymer & Rubber LLC, Ashland Inc. and many more.

The Global Styrene Butadiene Rubber Market accounted for USD 8.78 billion in 2018 and is projected to grow at a CAGR of 5.9% during the forecast period of 2020 to 2027.

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Major Market Competitors/Players//

Some of the major players in styrene butadiene rubber market Lanxess, Sinopec, The Goodyear Tire & Rubber Company, Michelin, JSR Corporation, Eastman, SIBUR, LG Chemicals, Dynasol Elastomer, Korea Kumho Petrochemical Company, LCY Chemicals, Versalis, Asahi Kasei Chemical Corporation, Styron-Trinseo, Synthos, Zeon Corporation, Shenhua Chemical Industrial Co. Ltd., Eastwest Copolymer & Rubber LLC, Ashland Inc. and many more.

Major Market Drivers:

Growth in tire market globally

Natural rubber creating opportunity for styrene butadiene rubber

Regulatory compliance

Market Restraint:

Environmental concerns

Fluctuation in raw material prices

Global Styrene Butadiene Rubber Market

By Type (E-SBR, S-SBR)

By Application (Tire, Footwear, Construction, Polymer Modification, Adhesives, Others)

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The Global Styrene Butadiene Rubber market research report offers the predictable forecast market growth trend on the basis of past business strategy, current market growth patterns the market is following, and the different guidelines and strategies authorized by the organization, which have been affecting or could affect the market development. In general, the global Styrene Butadiene Rubber market report provides the complete and in-depth survey of the Styrene Butadiene Rubber market at the global level.

The Global Styrene Butadiene Rubber Market Research Report Scope

• The global Styrene Butadiene Rubber market research report elucidates the market characteristics—from market description to its regional analysis.

• Regional segmentation analysis has been thoroughly researched in the global Styrene Butadiene Rubber market research report.

• Competitive study of the global market is evaluated on production capability as well as production chain, along with the key Styrene Butadiene Rubber market.

• The global Styrene Butadiene Rubber market is also analyzed on the production size, product price, demand, supply information and income generated by goods.

• For thorough analysis of the global Styrene Butadiene Rubber market, multiple analysis parameters such as asset returns, market appearance analysis and the probability have been used.

Market Segment by Regions, regional analysis covers:

North America (USA, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Columbia, etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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#Styrene Butadiene Rubber Market

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lupine-publishers-aoics · 5 years ago

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Lupine Publishers|Straw Based Biorefinery

Abstract

In India energy security and exploring the production of valuable chemicals , which are otherwise mostly imported have become imperative necessity The advantage of abundant availability of paddy and its straws, specifically the rice straw in India are taken as an example to establish a perfect Bio-refinery . In these paper possibilities of production of chemicals and energy by Chemical, Biochemical and Thermo chemical platforms are explored. Possible alternatives on the problems of stubble burning in some stares of India are put forward. However, studies on the optimal design, and economic viability of each routes remain to be evaluated.

Introduction

Biorefineries similar to petroleum refineries is a facility developed, engineered and designed optimally where renewable energy (heat & power) and multiples of chemical products and can be profitably manufactured from biomass with best known environmentally benign process technologies through biochemical and thermo chemical platforms. The energy production from bipomass is also Greenhouse neutral. Cellulosic biomass, because of its massive availability, can be a truly biorefinery representing a feedstock for biofuels and valuable chemicals. Agricultural residues such as straws are ideal candidates for establishing a biorefinery in India. Presently major quantity of straws is used as domestic fuels in rural areas. Rice Straw is produced from Rice Paddy. The various products and by-products are shown in the schematic diagram (Figure 1). On an average, there is 20% husks, 10% bran, 3% polishings, 1-17% broken rice and 50-66% polished rice. Generally Rice Paddy by-products is on an average 30% weight of paddy3).

Figure 1: Products and Bye-products from Rice Paddy (2).

The residual wastes (stubbles) are usually burnt in the field which leads to severe air pollution problems due to discharge of gaseous pollutants including CO, Ozone , N2O, NOx, SO2 , CH4, particulate matters ,smokes and smogs, hydrocarbons. Open burning of crop stubble also results in the emissions of harmful chemicals like polychlorinated dibenzo-p-dioxins, polycyclic aromatic hydrocarbons (PAH’s) and polychlorinated dibenzofurans (PCDFs) referred as as dioxins, besides loss of nutritional values of soil intermas of organic carbon, nitrogen, phosphorous and potassium in many states of India, especially Punjab, Haryana, Rajasthan and Uttar Pradesh. This is not that extent in other part of India. The main reasons are: larger length of the stubbles remains after harvesting in those states which cannot be economically covered under soil to enhance the fertility of the land and attempts to burn these long projected straws over the agricultural land. In the following paragraphs some alternatives to straw stubble burning are suggested [1].

Due to continuous depletion of non-renewable energy resources and high cost of chemicals due to import, at present there is a worldwide attention towards development of renewable resources of energy and chemicals for sustainable development for the welfare of mankind. For example: Economic production of bioethanol from lignocellusic biomass. Conversion of lignocellulosic plant materials to biochemicals is also regarded as one of the most promising alternatives to fossil fuels. Most abundantly available biomass in the countries like India and China are straws (rice, wheat, oats, rye, barleys, Zea Mays, corn stalks etc.), out of which rice straw occupies the first position and followed by wheat straw in terms of availability in Eastern, and North Eastern Indian states (West Bengal, Bihar, Assam, Orissa, Manipur etc.) whereas reverse is true for Northern India (U.P. Haryana, Punjab, Rajasthan etc.).

Conventional but Economic Uses of Rice Straw and Stubbles

a) Soil improver to increase the fertility

b) Manuring/Composting with cowdung and others etc.

c) Briquettes

d) mats

e) Mushroom cultivation(as growth substrate)

f) Vegetables Cultivation

g) Animal Bedding material

h) Poultry Litter & Mulch

i) Feed for ruminants/Animal feed

j) Packaging goods for transporting goods &machineries

k) Frost prevention in horticulture

l) Strawberries (preventing damage to the fruit)

m) Thatching

n) Rope making

o) Traditional building materials, fibre boards,Particle board, insulation material

p) Energy (heat, power, fuels)

q) An intergrated solid state fermentation approach for production of enzymes from agro-wastes including straws

Lignocellulosic biomass could thus be utilized for both production of biofuels as well as biochemical’s due to its nature of renewability, low price, widespread availability and containing high content of pentose and hexose sugar polymers. These are detailed elsewhere [2-6]. Straw and Stubbles can be used for various Chemicals, valuable products and energy. The most notable products which can economically manufactured are: Pulp & Paper, Particle Board, Pulp and Paper Board, Straw board, board of rice husk.

Energy technologies and thermal combustion consists of Non- Conventional uses of straws. Valuable chemicals include Cellulose, High Alpha cellulose, Plastics, Fuels and Energy,Bio-gas and in situ, Bio-oil, Nanocellulose and nano composites, Pentosans, Xylose, Xylitol, α-Cellulose, Glucose , Fructose, Hydroxy methyl Furan, Ethanol and host of many other chemicals [7-10]. These are shown in Figure 2.

Refineries based on Cellulose, Ethanol, Sucrose, Glucose, Lignin have been proposed and given elsewhere various Unit Operations and Processes involved to produce a biorefinery are as under:

a) Pulping

b) Gasification

c) Pyrolysis

d) Destructive distillation

e) Plasma Treatment

f) Chemical Treatment

g) Electron Irradiation

Chemical platform

a) Activated carbon

b) Chemical transformation through Catalyst(Sn-beta zeolites)

c) Synthetic Fuel using Solar Furnace

d) Cellulose nano crystals and nanocomposites:

Cellulose nanocrystals have been largely applied as reinforcing fillers in the preparation of nano composites materials with improved mechanical and barrier properties.

Figure 2: Products and Bye-products from Rice Paddy (2).

Bio-chemical platform

a) Renewable fuels: Ethanol, Biodiesel,Butanol, Hydrogen

b) Chemicals: Acetone,Furfurol,Propanediol, Ketones etc.

c) Organic Acids:Acetic, Lactic , Succinic, Gluconic, Butyric etc.

d) Bio-Energy: Lignate, Methane, Bio-gas, Heat, Electricity

e) Food & Feed: Single Cell Protein,Fat,Fiber, Sugar etc.

Chemistry of Formation

Go to

Monosachharides

D-Xylose,D-glucose, L-arabinose,Xylitol,fructose,D-mannose,Dgalactose

Hemicellulose

Furfural, through acid treatment, Biogas by anaerobic Digestion, concentrating to Animal Feed. Fructose /Fruit sugar →Hydroxymethyl furfural (HMF) →catalytic processes → Plastics, diesel fuel additives, or even diesel fuel [11,12].

Chemical or Biochemical Platforms: Dilute acid hydrolysis of lignocelluloses:

Acids: Carboxylic acids such as formic acid, acetic acid, 3-hydroxy propionic acids, succinic acid, fumaric acids, Malic acids, Itaconic acids, Levulinic acid, Glucaric acids, glucuronic acid, Vanillic acids, Syringic acids, Ferulic acids, p-coumarlic acid. Amino acids like Aspartic acids,Glutamic acids, Aldehyde: Syringaldehyde

Polyphenols: glycerol, Arabitol, Xylitol, Sorbitol Lactones such as 3-hydroxy butyrolactone

Phenolics: p-hydroxy benzoic acids and vanillin However,aldopentose xylose (20-40% of the total carbohydrates are normally found in agricultural residues.

Reaction Schemes (4,9,21,29,30)

Chemical reaction consists of series, parallel and combination of series-parallel reactions

Cellulose (Glucan)→ Oligosaccharides →Glucose →HMF→Levulinic acid

Hemicellulose →Oligosachharides→Sugars( xylose,arabinose, glucose, mannose, galactose)

Pentoses ( Xylose/ Arabinose)→ Furfural→ Furfural resinification and condensation products

Hexoses(Glucose/ Fructose ) → HMF→ Levulinic acid+Formic acid→Succinic acid

Furfural and HMF

Figure 3 Reaction Scheme and Kinetic models are developed (Pentosan( both xylan and arabinan) is hydrolyzed to both aldopentoses which are converted into two or more steps into furfural. Loss of furfural takes place due to side reactions which leads to condensation and to the formation of resins. Both levulinic acid and furfural can be produced from straw or any biomass & levulinic acid can be converted to succinic acid and formic acid [13].

Figure 3: Products and Bye-products from Rice Paddy (2).

Chemistry of formation

Xylan Xylose Furfural: Hexosan →Hexose (Unit Cellulose) → 5-hydroxymethyl-2-furfural + 5-methyl -2-furfural

Mechanism:

Hydrolysis:

xylan + water →H+Xylose

arbinan + water →H+arabinose

Dehydration:

Furan derivatives such as Furfural (2-furaldehyde), HMF (5-hydroxymethyl-2-furaldehyde), 2,5 furan dicarboxylic acids(33-35) are most important chemicals. HMF is produced industrially on a modest scale as a carbon-neutral feedstock for the production of fuels and other chemicals such as levulinic acid, gamma-valerolactone, or other byproducts. HMF itself has few applications and it is primarily produced in order to be converted into other more useful compounds [14-20]. Of these the most important is 2,5-furandicarboxylic acid, which has been proposed as a replacement for terephthalic acid in the production of polyesters. HMF can be converted to 2,5-dimethylfuran (DMF), a liquid that is a potential biofuel with a greater energy content than bioethanol. Hydrogenation gives 2,5-bis(hydroxymethyl) furan. Acid-catalysed hydrolysis converts HMF into gamma-valerolactone, with loss of formic acid. HMF is practically absent in fresh food, but it is naturally generated in sugar-containing food during heat-treatments like drying or cooking. Along with many other flavor- and color-related substances, HMF is formed in the Maillard reaction as well as during caramelization. In these foods it is also slowly generated during storage. Acid conditions favour generation of HMF. HMF is a well known component of baked goods. Upon toasting bread, the amount increases from 14.8 (5 min.) to 2024.8 mg/kg (60 min). It is a good wine storage time−temperature marker, especially in sweet wines such as Madeira and those sweetened with grape concentrate arrope [21-24].

Fermentation Technology

Bio-Ethanol

Sachharomyces cerevisiae, Zymomonous Mobilis, Clostidium thermocellum, Ruminococcus albus- a bacterium are generally used for conversion of cellulose to ethanol. Theoretically 1kg of sucrose on inversion, gives 1.053 kg of invert sugar, glucose and fructose combined together. Further,one tone of invert sugar yields 644.8 litres of absolute alcohol(ethanol of 100% ) or 678.7 litres of rectified spirit.The net CO2 emission of burning a biofuel like ethanol is zero since the cO2 emitted on combustion is equal to that aabsorbed from the atmosphere by photosynthesis during growth of the plant(sugarcane) used to manufacture ethanol.

Inversion: C12H22O11+H2O→C6H12O6+C6H12O6

Sucrose + Water →Invertase→Glucose + Fructose (Invert Sugars)

Fermentation: C6H12O6→2C2H5OH+2CO2+27.8kCals xymase

Oxidation: C2H6O+3O2→2CO2+3H2O+Δ

Combined equation: C6H12O6+6O2→6CO2+6H2O+Δ

6CO2+6h2O+hv(light)→C6H12O6+6O2

Butanol

Biobutanol is produced by microbial fermentation, similar to bioethanol, and can be made from cellulosic feedstocks such as straws. The most commonly used microorganisms are strains of Clostridium acetobutylicum and Clostridium beijerinckii, C. Saccharoperbutylacetonicum and C. saccharobutylicum. In addition to butanol, these organisms also produce acetone and ethanol, so the process is often referred to as the “ABE (acetone-butanolethanol) fermentation [25-30]. Production of lactic acid from straw derived cellulose,cellulase production with Tricoderma citriviridae on solid bed, use of acid hydrolysates for lactic acid production using various strains such as Lactobacillus delbrueckii or lactobacillus pentosus can be explored.A number of products can be produced from sucrose as shown in Figure 4.

Figure 4: Products and Bye-products from Rice Paddy (2).

Anaerobic Digestion

Biogas production (25,31-32), Anaerobic conversion of carbohydrate /cellulosics, especially of agricultural residues , has been considered for biogas ( methane) production which is typically, CH4=50-65%, CO2=35-50%, H2O=30-160g/m3, H2S=1.5-12.5g/ m3 inn presence of methane producing bacteria. Typically some of the methane forming microorganisms likes Methanaomonas, Methanococcous mazei n.sp. methannobacterium sohn genii n.sp. etc. are employed. The two best described pathways involve the use of acetic acid or inorganic carbon dioxide as terminal electron acceptors:

CO2+4h2→CH4+2H2O

CH3COOH→CH4+2CO2

During anaerobic respiration of carbohydrates, H2 and acetate are formed in a ratio of 2:1 or lower, so H2 contributes only ca. 33% to methanogenesis [31], with acetate contributing the greater proportion. In some circumstances, for instance in the rumen, where acetate is largely absorbed into the bloodstream of the host, the contribution of H2 to methanogenesis is greater.

Buswell and Symons universal equation:

CnHaOb+(n-a/4-b/2)H2O→(n/2-a/8+b/4)CO2+(n/2+a/8-b/4)CH4

Thermo-chemical platform

Gasification Technology

The basic principles of Gasification technology are as under:

a. Steam Reforming of Straws:

Superheated steam reacts endothermally (consumes heat) with the carbonaceous components of straws to produce hydrogen and carbon monoxide fuel gases (synthesis gas or syngas)

b. Steam Reforming reaction: H2 O +C + Heat → H2 +CO

Water –gas shift reactions also occur simultaneously with the steam reforming reactions to yield additional hydrogen and carbon dioxide.

c. Water gas shift reaction: H2 O +CO→ H2- +CO2

Conclusion

India being an agriculture based country with plenty of biomass renewable resources can produce potential bio-products and bio energy at a cheaper rate compared to other renewable sources. Being carbon neutral these resources is eco friendly, yields much less green house gaseous emissions compared to fossil fuels [32- 37]. In this present paper various alternatives for straw utilization, specifically the plausible solutions of current problems of straw stubble burnings in a few Indian states are highlighted. However detailed optimum design of process and plant with economic feasibility need to work out.

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