Goodwin Biotechnology Bolsters Quality & Regulatory Capabilities

Goodwin Biotechnology has appointed Gerald Orehostky as vice president, quality and regulatory. As a full GMP, FDA-registered and inspected biopharmaceuticals contract development and manufacturing organization (CDMO), Goodwin has continued its expansion to add commercial cGMP solutions to augment its offering of 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 life-saving monoclonal antibodies, recombinant proteins, vaccines, and antibody drug conjugates (ADCs).
 
"Jerry has more than 30 years of broad experience in quality systems, regulatory affairs, regulatory compliance, quality assurance, product development and commercial operations in biologics, bioconjugation, and other therapeutic areas," said Karl Pinto, chief executive officer, Goodwin Biotechnology. "His extensive experience and, in-depth functional proficiency in quality assurance and regulatory affairs from early stage to commercial products will help guide Goodwin as we continue our expansion plans to continue our nearly 30-year legacy of servicing our clients in bringing their products into, and through the clinic with our unmatched service, flexibility, and quality. We are now transcending the clinic and taking the company into commercial manufacturing, and Jerry's leadership will be instrumental towards this endeavor."
 
Previously, Mr. Orehostky held leadership positions within regulatory affairs and quality operations at companies such as Actinium Pharmaceuticals, Antares Pharma, Discovery Laboratories, Palatin Technologies, Schering-Plough, Vivus, and Interferon Sciences.

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