bioprocessingalliance-blog

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All About Biologics Consulting Services

Biologic substances are composed of organic matter, like tissues and cells, or nucleic acids, proteins, or sugars. They originate from microorganism, animal, or human sources, and are extracted using innovative biotechnology techniques. Biologics are used in biologics manufacturing research, which includes medical genetics, and cellular and molecular-based research. The use of biologics in biologics manufacturing research produces advanced pharmaceutical outsourcing products, which may provide powerful treatments for an array of medical conditions. Biologics manufacturing and pharmaceutical outsourcing are responsible for significantly advancing medical research in the 21st century.

Pharmaceutical outsourcing is especially important in Canada, where we have the 8th largest pharmaceutical market in the world, and are home to one of the highest number of biologics companies worldwide.

Biologics consulting can efficiently help pharmaceutical outsourcing programs through the complex and challenging processes of biologics manufacturing development: from testing and trialing your product, to acquiring approval from regulatory sources, to putting your product on the market.

Since their introduction in 2010, Bio Processing Alliance, Inc. (BPAI) has established itself as an innovative leader in biologics consulting. The consulting team at BPAI is committed to supporting the goals of biologics programs, from concept to biologics process development to manufacturing to outsourcing. BPAI’s extensive experience allows us to efficiently manage our clients’ biologics manufacturing and pharmaceutical outsourcing programs. Our expertise has proven to offer our clients a competitive edge. Contact us today to talk to our experts.

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Do You Qualify for the Scientific Research and Experimental Development Program?

The Canadian government’s Scientific Research and Experimental Development (SR&ED) Program is a federal tax incentive program created to encourage Canadian businesses to conduct research and development in Canada. The program is administered by the Canada Revenue Agency (CRA).

Our company, Bio Processing Alliance, is an expert biologics consulting team that’s committed to helping your business through every stage of your project. We can help determine if your biomanufacturing or biologics project qualifies for the SR&ED program and help you prepare the required documents for the CRA, so you can get your cheque faster.

What are the benefits of the SR&ED program?

Allow you to deduct SR&ED expenditures from your income for tax purposes.

Provides you with an SR&ED investment tax credit (ITC) that you can use to reduce your income tax payable.

Who can make a claim on qualified SR&ED expenditures?

Canadian-controlled private corporations: can earn a refundable ITC at the enhanced rate of 35%, up to a maximum threshold of $3 million.

Other corporations: can earn a non-refundable ITC at the basic rate of 15%.

Individuals and trusts: can earn a refundable ITC at the basic rate of 15%.

Members of a partnership: will have their ITC calculated at the partnership member then allocated to eligible members. For more information, read the SR&ED Claims for Partnerships Policy.

What work qualifies for the program?

Basic research undertaken for the advancement of scientific knowledge without a specific practical application.

Applied research undertaken for the advancement of scientific knowledge with a specific practical application.

Experimental development undertaken for the purpose of technological advancement to create new or improving existing materials, devices, products, or processes.

Work undertaken by or on behalf of the taxpayer with respect to engineering, design, operations research, mathematical analysis, computer programming, data collection, testing, or psychological research.

How can Bio Processing Alliance help your claim?

Provide professional advice about whether your project qualifies.

Interview your staff to identify projects to identify projects that meet CRA criteria and prepare technical documentation.

Identify costs associated with the project for tax documents.

Prepare the technical and financial forms for you and your accountant.

Coach your staff to collect the necessary data.

Assist you if the CRA conducts an eligibility review.

All you have to do is describe your project, collect your financial records, and sign the forms. Our program is also risk-free. Our fees are contingency-based, meaning we only get paid when you do.

Bio Processing Alliance has been a leader in biologics consulting since 2010. The biologics consulting team at Bio Processing Alliance is committed to supporting the goals of biomanufacturing programs, from concept to biologics process development to biomanufacturing. The bioprocess consultants at Bio Processing Alliance have extensive bioprocessing experience, which allows us to efficiently manage our clients’ programs. We have a reputable track record of enhancing company value. Our biologics and bioprocess consultants, along with our biomanufacturing expertise, have proven to offer our clients a competitive edge. Contact us today to find out if your project qualifies for the federal SR&ED program, and how we can help.

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What You Need To Know About Technical Program Management

For the past seven years, the Bio-Processing Alliance Inc. (BPAI) team of biologics and bioprocess consultants has been providing service and solutions to leading biomanufacturing, biologics, and biosimilar companies worldwide.  While there are many facets to our business and several ways that we can support your success, today we are highlighting the key elements we offer when it comes to Technical Program Management.

Development & Technology Transfer and Scale Up

BPAI has a proven track record of success and our bioprocess consultants are committed to improving and supporting your programs and processes.  BPAI understands the uniqueness of biologics manufacturing and utilizes our extensive, real-world experience managing complex scale-up, engineering and GMP biomanufacturing projects to continually help our clients achieve their goals.

When we’re talking specifically about Technical Program Management, there are several ways that we can assist you.

Development

At just about any point in your program, BPAI can work with you to improve, maintain or support your organization’s strategic objectives.

Process Development – assist your organization with effective and scalable biologics process development that will optimize your process and allow for the expression and purification of valuable products.

Upstream Development – our expert bioprocess technology consultants have experience in a wide variety of host cell types and expression systems. Not only can we assist in the selection of equipment but we can also offer guidance for cell line development, initial expression, and stability studies.  BPAI also supports process troubleshooting for quality, yield, and robustness.

Midstream Development – focus on host organism or cellular debris separation while maximizing recovery and maintaining product activity. Whether you need support with filtration optimization or continuous centrifugation bioprocessing optimization, we have knowledge that can help.

Downstream Development – Product purification and polishing should produce purity and activity levels eligible for human clinical trials. However, purification as part of biologics process development program often comes with complex issues and challenges that can cause a bottleneck in biomanufacturing processing. BPAI has the experience you need to help you develop effective purification processes that are robust, scalable, efficient and transferrable.

Analytical Development –Clinical trial development and biomanufacturing programs need reliable and reproducible analytical methods. BPAI can assist in designing and implementing analytical support for biologics programs and can make suggestions on process flow, analytical transfer protocol, qualification and validation protocols and offer real-time monitoring and interaction during protocol execution.

Biologics Manufacturing – GLP & cGMP – This step defines the purpose of all the work you’ve put into your biologics process development project. BPAI’s bioprocessing technology consultants become a hands-on part of your team and work in the plant to offer personalized service designed to meet your specific needs.

Quality & Compliance - In addition to our diverse biologics process development and biomanufacturing experience, BPAI is also a top choice when it comes to quality and compliance. From the development of GMP-based quality systems to the implementation of environmental and utility monitoring programs, our Bioprocess consultants are ready to help you work through any issues related to areas such as auditing, quality control laboratory design and GMP introductory training.

Technology Transfer and Scale Up

BPAI knows that the transfer and scale-up process can be a costly and risky experience.  Working with our bioprocess technology consultants will allow you greater peace of mind as you can rely on our successful track record when it comes to technology transfers and scaling microbial, yeast, insect and mammalian cell biologics processes from lab bench to manufacturing scale.

Technology transfer services that we can assist you with include:

Inter-site transfers: lab to lab, non-cGMP to cGMP, cGMP to cGMP

Drafting, review, and approval of technology transfer protocols

Guidance in developing bioprocessing scale-down models for successful technology transfers

Bioprocessing assessments for cGMP readiness, robustness, and scalability

Advice on site transfers, scale-up, and compliance

Process technology transfer oversight

Analytical methods such as implementation, development, qualification, and validation

Achieving Successful Technical Program Management

We know you want to get the results that you need.  When you commit to working with the expert team of bioprocess consultants at BPAI, know that you will be getting a depth and breadth of professional experience that enables us to give you complete holistic support.

We are a results driven organization that focuses on achieving success for our clients and know that we can help you with your biologics process development challenges. If you are ready to learn more about working together, contact us at 905-636-6559.