| Type | Private |
|---|---|
| Industry | Biotechnology, Contract manufacturing |
| Founded | 1992 |
| Headquarters | Plantation, Florida |
| Services | Bioconjugation, Biosimilars/Biobetters, Cell culture |
| Employees | 43 |
| Website | www.goodwinbio.com |
According to its website, Goodwin Biotechnology, Inc. ("GBI") is a fully integrated cGMP Contract Manufacturing Organization or (CMO) of monoclonal antibodies, recombinant proteins and vaccines.
Contents |
Goodwin Biotechnology, Inc. was established in 1992, as a biopharmaceutical Contract Manufacturing Organization and formerly affiliated with The Rumbaugh-Goodwin Institute for Cancer Research, Inc. In 2004, GBI was acquired by Wallace Pharmaceuticals Pvt. Ltd., which currently markets over 100 products focusing on Antibiotics, Gastro-intestinal, Rheumatology, Dermatology, Gynecology, Diabetes, ENT and Pediatric products.
Goodwin Biotechnology, Inc. is a world-class CMO that excels as a strategic partner to deliver the highest quality material from proof of concept through Phase I / II clinical trials by employing superior cGMP compliant services that enable cost-effective, on-time delivery of their client's pre-clinical and clinical supplies to enhance patient's lives. Services are listed below:
•Cell Culture
•Cell Banking
•Process Development
•cGMP Manufacturing
•Aseptic Fill and Finish
•Bioconjugation
•Purification
•Transgenics
Biologicals represent the fastest growing segment of the pharmaceutical market and over 30 branded biological with sales in excess of $50 billion are facing patent expirations. GBI has worked on a number of innovative biologics for companies of all sizes from large multinational pharmaceutical firms to small entrepreneurs and offers the following regarding any Biosimilar/Biobetter project:
•Design Manufacturing and Process Development Strategies
•Design Analytical Approach
•Design Regulatory Strategies
GBI provides Assay development and characterization, routine testing, development, validation of assays employing techniques such as:
•HPLC (Reverse Phase, Size Exclusion, Ion-exchange)
•ELISA (potency, host cells proteins, residual contaminants)
•Gel electrophoresis (SDS and IEF)
•Western Blot analysis
•Protein concentration (by UV, colorimetric)
•Measurement of the ratio of protein to a chelating agent (for bioconjugation processes)
•Identification of raw materials
•Pharmaceutical microbiology Endotoxin by gel clot Bioburden, sterility, BNF Total organic carbon (TOC) Samples for environmental and purified water
•Product release and stability testing following ICH guidelines
•Quality Assurance
•Quality Control
May 2011 - For Cell line Engineering Project Goodwin Biotechnology and RAFAGEN Announce a Collaboration for Cell Line Engineering
October 2010 - Goodwin Biotechnology Inc. and Macrocyclics Announce Collaboration for Unique Bioconjugation Linkers