CDMO Goodwin Biotechnology To Double cGMP Biomanufacturing Capacity With Expansion

Goodwin Biotechnology, Inc. announced that it has recently purchased the two-acre site where the company has flourished for over 26 years in order to expand its capacity to meet the needs of its long-term clients. Goodwin Biotechnology is a US-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,” noted Karl Pinto, Chief Executive Officer at 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 our expansion was increasing the Process Development capabilities to better serve our growing customer base,” noted SooYoung Lee, PhD, Chief Operating Officer at Goodwin Biotechnology. “This included a significant increase, effectively more than doubling our Development bioreactor laboratory scale where we perform multiple small-scale bioreactor runs in parallel as we optimize and validate the cell culture process to develop reproducible and scalable bioreactor processes for GMP manufacturing for our clients. 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” added 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.”

About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a uniquely qualified and flexible, US-based CDMO that offers a Single Source Solution™ for our clients from cell line development, exploratory proof-of-concept projects through process development and cGMP contract manufacturing of monoclonal antibodies, recombinant proteins, vaccines, and Biologic Drug Conjugates including Antibody Drug Conjugates (ADCs) for earlyand late-stage clinical trials. By working with Goodwin Biotechnology, clients can enhance the value of their product candidates with clear development and manufacturing strategies, as well as a road map to meet the appropriate quality requirements from the milligram and gram range to kilogram quantities as the product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner to enhance patients’ lives. With over 26 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has been awarded Frost & Sullivan’s Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing! In addition, Goodwin Biotechnology was awarded “Best in Sector: Biopharmaceutical Contract Development & Manufacturing” at Acquisition International magazine’s 2015 Sector Performance Awards. Last year, Goodwin Biotechnology received Global Health & Pharma’s 2017 award for Best for BioProcess Development & cGMP Manufacturing and Best in Mammalian Cell Culture Process Development & cGMP Manufacturing. In 2018, Goodwin Biotechnology was named Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News. For more information, visit http://www.GoodwinBio.com.