Biologics

CDMO

Q4 2016

Specialty and biological drugs that require complex manufacturing, such as fermentation, are projected to account for half of the pharmaceutical industry by 2020,1 with facilities that develop and manufacture many of these compounds looking to expand current operations by 25% in the same time frame.2

Biopharmaceutical companies with portfolios heavily staked in the development of therapeutics that require some form of fermentation — namely many active pharmaceutical ingredients (APIs), peptides, antibodies and other small molecules — face the challenge of creating medium- and long-term production plans. Building a new bioprocessing facility that is capable of handling the development and manufacturing of complex biotherapeutics can cost anywhere from $50M to $650M, and may require up to four years to complete.3 Although the upfront cost of building a facility may seem substantial, it is often much less than the potential revenue lost by missing a drug launch date, which is estimated at anywhere from $1M/day to $14M/day — with “blockbuster” drug releases reaching even higher.4 In order to mitigate the amount of time and effort necessary to build a new facility, many biopharmaceuticals form strategic partnerships with specialized CDMOs that already have the necessary bioprocessing facilities in place.
Established on Prince Edward Island in Atlantic Canada 45 years ago, BioVectra has 10-plus years of experience in producing small molecules, APIs (including high-potent APIs and cytotoxic compounds), peptides, and complex antibodies using filamentous fungal and bacterial strains, native and recombinant bacteria, and saltwater microbial organisms. In the past year the organization has had a 100% success rate in fermentation reactions, producing 33 distinct sets with an average titer well above the industry standard.5 Recently the company has expanded their fermentation capabilities to include a third commercial fermentation suite in the geographically distinct location of Windsor, Nova Scotia.
By the end of 2016, the three fermentation suites — each capable of producing cGMP products — will have a total capacity of over 65,000 liters. Each of the three suites house bioreactors of different capacities to meet a client’s specific needs, whether it be research and development (2 x 30 L; 1 x 100 L; 1 x 130 L), clinical (1 x 500 L; 1 x 1,000 L; 1 x 1,500 L; 1 x 3,000 L), commercial (1 x 10,000 L; 1 x 15,000 L; 2 x 17,000 L) or any combination of the three. Experience paired with the diversity and breadth of upstream equipment makes BioVectra an ideal partner for producing both commercial mainstream biotherapeutics and assisting in the development and production of biotherapeutics for a niche market.&nbsp;
<h4>References</h4>
<ol>
<li>Looney, William. “2016: A Biopharma Market in Flux.” Pharmaceutical Executive. 20 Jan. 2016. Web.</li>
<li>Wright, Tim. “Top 15 Trends in Biopharmaceutical Manufacturing.” Contract Pharma. 30 July 2015. Web.</li>
<li>Farid, Suzanne S. “Process Economics of Industrial Monoclonal Antibody Manufacture.” Journal of Chromatography B 848.1 (2006): 8-18. Web.</li>
<li>Hernandez, Randi. “Managing Biomanufacturing Capacity Expectations.” Biopharma International. 1 July 2016. Web.</li>
<li>A Unique Manufacturing &amp; Development Partner. Biovectra. 2016. Web.</li>
</ol>
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Finding The Ideal Partner for Your Next Biotherapeutic