Our World Class Facilities
Goodwin Biotechnology occupies one facility of over 38,000 sq. ft. that is designed and utilized for process development, scale-up, cGMP manufacturing, as well as QA and QC labs and support services. Manufacturing equipment and its parameters are monitored 24-hour via a computer controlled alarm system. Goodwin Biotechnology is equipped with emergency backup generators in the event of a power loss. Goodwin Biotechnology has a facility staff on site to aid in monitoring and maintenance of manufacturing equipment and its associated utilities.
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We Welcome Audits
We’re proud of our facility and our staff. Stop by and see for yourself. We’ve had over 85 successful audits from clients, auditors and regulatory agencies, including the FDA.
Rajesh Beri, Ph.D., Senior Vice President, Operations noted that “Regarding the FDA audit, no observations were listed on an FDA-483 form. The FDA personnel observed and reported that our personnel are proactive in making sure that the proper procedures are in place.”
“We welcome audits, a fresh perspective on our system and processes is invaluable,” commented Prema Rathinavelu, M.Sc., Associate Vice President, Quality Control.
“At Goodwin Biotechnology, both Operations and Quality groups work synergistically, taking a holistic, risk-based approach to quality and compliance, building quality in our processes,” continued Muctarr Sesay, Ph.D., Chief Scientific Officer.
“It is refreshing that the people who audit us tend to be very complimentary about the skill level and commitment of our staff, and the sophistication of our facility.” noted Dr. Beri.
Advance your biopharmaceutical candidate
Contact us for more information on our facilities or to learn how we can help advance your biopharmaceutical candidate.