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:

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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 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.

Upstream Process Control

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.

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Bioconjugation

The bioconjugation of monoclonal antibodies and recombinant proteins with other molecules is a specialty of Goodwin Biotechnology’s bioconjugation development and manufacturing groups.

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