PLANTATION, Fla., March 20, 2018 /PRNewswire/ -- Goodwin Biotechnology, Inc. is a US-based, uniquely qualified and flexiblefull GMP Contract Development and Manufacturing Organization (CDMO) that offers a fully integrated Single Source Solution™ from cell line development, process development, scale-up, cGMP contract manufacturing, and aseptic Fill/Finish of mammalian cell-culture
"We are proud to have received such a distinguished award, especially when it became known that we were competing against 19 other companies for this title," said Karl Pinto, CEO at Goodwin Biotechnology. "This and other significant accolades we have received over the years are testaments to how we enhance the value of our clients' product candidates with clear development and manufacturing strategies by providing a road map to meet the appropriate quality requirements from the milligram and gram range to hundreds of gram quantities as their product candidates move along the clinical development pathway in a cost-effective, timely, and cGMP compliant manner."
"Established in 1992, Goodwin Biotechnology was one of the first, fully integrated CDMOs. Since then, Goodwin Biotechnology has been a customer-focused, flexible strategic partner for companies of all sizes from large multi-national biopharmaceutical companies to university spin-offs, major research institutes, government agencies and small virtual biotech startups from all over the world," noted SooYoung Lee, Ph.D., COO at Goodwin Biotechnology. "We have developed and optimized bioreactor and purification processes for a number of industrially important cell lines including CHO, NS/0, BHK, 293, as well as murine hybridomas, and have completed more than 400 projects, the majority of which were for Phase I through Phase III clinical trials."
"In addition, Goodwin Biotechnology is one of the pioneers in providing development and cGMP manufacturing of Antibody-Drug Conjugates ( ADCs), including Cytotoxic-immunoconjugates, Radio-Immunoconjugates, Peptide-Immunoconjugates, and other biomolecule conjugation services for over 15 years," added Muctarr Sesay, Ph.D., CSO and VP of Bioconjugation at Goodwin Biotechnology. "We provide random and proprietary site-directed conjugation of payloads to antibodies or proteins to improve conjugate binding, and with our high containment SafeBridge® level 4/5 ISO7 facility for handling highly cytotoxic, small molecule drugs and the receipt of a DEA manufacturer's license for the development and manufacturing of controlled substances such as opioids, we can meet the special needs of a variety of clients."
"Based on this success and coupled with the needs of our current and prospective clients, Goodwin is embarking upon our next stage of growth in 2018 with a commercial facility build out plan in progress," continued Mr. Pinto. "The conceptual design is in process and we plan to be ready to provide commercial manufacturing services by mid-2019."
For more information or to explore how we can help you meet the outsourcing needs for your product candidates, please visit the Goodwin Biotechnology web site (www.GoodwinBio.com) or e-mail us at Info@GoodwinBio.com.
About Goodwin Biotechnology, Inc. Goodwin Biotechnology is a uniquely qualified and flexible 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 early and 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 25 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. Click here to view the press releases! Additional information may be found at http://www.GoodwinBio.com.
For more information, please contact:
Goodwin Biotechnology: Kayla Harris Business Development Associate 954-327-9688 KHarris@GoodwinBio.com
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SOURCE Goodwin Biotechnology, Inc.
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