Goodwin Biotechnology has recently purchased the two-acre site where the company has operated for over 26 years in order to expand its capacity to meet the needs of its long-term clients. The company is a U.S.-based, FDA-registered, uniquely qualified and flexible full GMP biopharmaceutical contract development and manufacturing organization (CDMO) that offers a fully integrated Single Source Solution from cell line development, process development including bioconjugation, scale-up, cGMP contract manufacturing, and aseptic fill/finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and antibody dug conjugates (ADCs).
 
“The Goodwin team is really excited about this next chapter in our business story,” said Karl Pinto, chief executive officer, Goodwin Biotechnology. “Based on the success of biopharmaceutical candidates that we have helped successfully navigate through their early- and late-stage clinical trials, we have strategically aligned ourselves to invest in doubling our cGMP manufacturing capacity and enhancing our regulatory compliance to support commercial manufacturing. This is a testament to the dedication, commitment and the vast experience of the highly skilled scientists who make up the Goodwin Biotechnology family, as well as the strong, successful client relationships that we have built over the years.”
 
The first phase of Goodwin’s expansion was to increase process development capabilities by more than doubling its development bioreactor. The laboratory scale bioreactor is where it performs multiple small-scale bioreactor runs in parallel as it optimizes and validates the cell culture process to develop reproducible and scalable bioreactor processes for GMP manufacturing for clients.
 
SooYoung Lee, chief operating officer, Goodwin Biotechnology, said, “We’ve also expanded our purification and bioconjugation development capabilities as well as our method development groups and infrastructure to enable us to characterize in-process samples, develop analytical methods, and to provide analytical services so that we are able to characterize upstream and downstream processes in real time, thus ensuring that we can successfully complete our clients’ campaigns on time and on budget. Now that we have purchased the entire site from which we currently operate, we have access to significantly more space as we prepare for the second phase of the expansion which will feature an increased scale in our cGMP manufacturing capacity in order to support the commercial production needs of our clients’ biopharmaceutical products.”
 
“These strategic investments and clear growth roadmap demonstrate our commitment to support our clients through all stages of their product development cycle, including continuous commercial production,” said Mr. Pinto. “Goodwin helps fill a niche in the industry as a unique and viable manufacturing partner built to efficiently handle small to mid-volume product needs, which we increasingly see as the future of biopharmaceutical manufacturing.”