Who We Are
Goodwin Biotechnology offers you a Single Source Solution™ with a full range of mammalian cell culture development and 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.
- Approximately 30 percent of our scientists have Masters and Ph.D. degrees with experience working at many of the largest global Biopharma and CDMOs
- Experience with over 150 clients on almost 500 different biologic projects
- Experienced in successful FDA and EU regulatory agency inspections
- Preparation of over 45 IND submissions (CMC sections) in Goodwin’s history
Goodwin Biotechnology eliminates the manufacturing risk for companies developing complex biologic therapeutics by being the pre-eminent provider of high-quality, cost-effective, flexible and timely cGMP-compliant manufacturing solutions, from pre-clinical development through commercial product supply.
Our Heritage and Focus
While many CMOs entered the biotechnology CMO market as a for-profit organization, Goodwin Biotechnology has a different heritage. Born from the Goodwin Institute for Cancer Research, one of the first manifestations was the value of blending scientific expertise with a passion for the patient. This fueled a number of promising advancements in the treatment of cancer at the bench-top level. The rigors of scaling up with therapeutics to test that promise, coupled with governmental rules and regulations, fueled an important business decision in 1992, Goodwin Biotechnology, Inc. was born. Since then, we’ve maintained one key attribute, a focus on the patient. That’s what motivates us to do a great job on your project.
In the biologics CDMO niche, Goodwin Biotechnology was the first to engineer the concept of “full integration”, which enables us to work with our clients from Proof of Concept through the manufacture of preclinical and clinical trial products. It is a process we termed “GMPnization”. In other words, we begin with the end in mind. Regardless of whether you are working on a proof-of-concept project or need a partner to manufacture material for clinical studies, we employ cGMP quality from the initial production step of developing the genetically engineered “production” cell line all the way through scale up and vialing of the final biopharmaceutical product.
Goodwin Biotechnology has an enviable reputation for regulatory compliance and, throughout our history, we have provided superior service for our clients that not only meets, but exceeds their expectations. We look forward to helping you realize the promise of your protein!
We can help you realize the promise of your protein.