Biopharmaceutical Manufacturing Solutions
The challenge of finding a partner to support your cell culture manufacturing solutions is overcome through Goodwin’s integrated range of services as illustrated in the following:
This Single Source Solution™ includes:
Analytical Method Development
Analytical method development is essential to insure safety, purity and efficacy of the drug candidates during the biopharmaceutical manufacturing process. Analytical methods must be qualified during the drug development process before entering clinical trials, and this is a core competency offered by Goodwin Biotechnology.
Biologics Contract Manufacturing
Goodwin Biotechnology offers a Single Source Solution™ with a full range of mammalian cell culture development and cGMP manufacturing services ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept or toxicology product material to processes for licensed biopharmaceutical manufacturing.
Upstream Cell Culture
Goodwin Biotechnology’s upstream process development team will develop a robust and reproducible upstream cell culture process for the scale up and manufacture of complex therapeutic biologic drug candidates.
Downstream Purification
As the product proceeds through its clinical evaluation, Goodwin Biotechnology can optimize and refine the protein purification process including the testing and establishment of parameter limits.
Aseptic Fill and Finish
Goodwin Biotechnology maintains an ISO5 filling suite that provides customized, economical, and compliant liquid filling of client products under cGMP and non-GMP conditions. In response to the market’s increasing demand for these services, Goodwin has made a significant investment to expand our fill and finish capacity.
Bioconjugation
The bioconjugation of monoclonal antibodies and recombinant proteins with other molecules is a specialty of Goodwin Biotechnology’s bioconjugation development and manufacturing groups.
