Frederick Based Biosimilars Company begins GMP Manufacturing and Scales Headcount

Image Credit:

BioFactura Inc. is a growing biotech company in Frederick, Maryland operating in an exciting and growing field.  The company develops and commercializes high-value biosimilars (i.e. generic biopharmaceuticals) using its patented StableFast ™ Biomanufacturing Platform which provides a superior and more efficient method to bring these drugs to market. The company just begin their first GMP product runs in their fully integrated drug development and clinical manufacturing facility. With this milestone the company is perfectly poised to support its biosimilars product development programs as well as its growing contract services business.

BioFactura’s contract services include cell line development, process development, and Phase I/II GMP manufacturing for industrial, academic, and government institutions.  Their platform technology provides the optimal system for bringing these drugs to market with faster, lower cost, superior-quality, making them a very attractive partner to drug manufacturers looking to capitalize on the benefits of pursuing their biosimilars development programs.

To support their growing client demand the company has added key staff to their process development teams and is currently hiring for an Associate Director to run the downstream purification department. “The addition of these strategic hires put us in great position to not only deliver for our existing clients and programs, but to respond quickly to new clients as we grow,” said Darryl Sampey, Ph.D., President and CEO.  “We are an entrepreneurial company that hires based on character and potential, so we take great effort to find the right people who will join us on this journey as we scale over the next few years.”

Interest in the biosimilar protein drug market continues to grow, much due to the cost-savings that consumers hope to gain, the shorter development time to market, and opportunities for alternative pharmaceutical manufacturers to enter both established and emerging markets. However, success in this emerging industry comes with some challenges including selecting the right cell lines, processes development complexity, strict manufacturing practices that place a high demand on safety expectations by the U.S. Food and Drug Administration (FDA) regulations, and of course yielding a return on investment.  BioFactura has expertise in these areas and is now positioned to stand out as a leader among biosimilar contract manufacturing organizations with their StableFast ™ Biomanufacturing Platform.

It has been just two years since BioFactura closed an oversubscribed Series A funding round and opened a new 5,500+ sq. ft. headquarters and R&D/manufacturing facility in the Riverside Research Park (image above).  In addition to the investment round the company received a $50,000 loan from the state of Maryland, and $10,000 from the city of Frederick with the promise of bringing on 25 new employees by 2020.

Since then the company has made steady progress and announced several strategic achievements towards its goals.  In 2016 they secured a Chinese patent for their StableFast ™ platform enhancing their ability to serve a global market and entered into a non-exclusive license agreement with Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), relating to one of the biosimilar product candidates that Momenta is developing.  Now with the new GMP facility and a growing team BioFactura is on a course to become a major player in the global biosimilars industry, and in Maryland.

To learn more about BioFactura you can view their Company Profile to see all past news and ‘Follow’ them to stay up to date on all future news, jobs and more from the company.


Chris Frew, @biobuzzMd

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.