Goodwin Biotechnology, Inc. Is Now GBI!

PLANTATION, FL-- Goodwin Biotechnology is becoming GBI and expanding to launch a brand-new, larger-capacity cGMP biologics facility.

Though the name may change, GBI’s mission remains the same: from clinical to commercial products, providing high-quality, cost-effective, flexible, and timely cGMP-compliant manufacturing solutions to eliminate the manufacturing risk for companies developing complex biotherapeutics.

GBI says it is as committed as ever to bringing its decades of experience to new and existing partnerships with those seeking a reliable CDMO that can nimbly face the various challenges that arise throughout every stage of the development and manufacturing cycle.

What Does GBI Do?

“Since we started more than 30 years ago,” says CSO Muctarr Sesay, Ph.D., “We’ve completed over 500 projects for more than 150 clients. We continue focusing on monoclonal antibodies (mAbs) because GBI has so much experience and depth with them. Still, we also have experience with modified and more complex antibody-based molecules, such as fragments, bi- and tri-specifics, other recombinant proteins, as well as the very specialized area of bioconjugation (antibody–drug conjugates (ADCs) and bioconjugates).

“Our two greatest strengths are our process and technology development and our cGMP manufacturing capabilities for biologics — including both drug substance (DS) and drug product (DP). We have clients who are doing first-in-human and early-stage clinical trials, as well as products that are in late-stage trials; thus, our integrated IND- and BLA-enabling experience and robust platform-based approach is critical for them.”

“GBI has handled many different projects in both late and early stages,” says VP of Business Kenneth Meek, “which has enabled us to develop what we call a Single Source Solution for our clients. This includes GMP cell banking, analytical methods development, antibody characterization services, clinical cGMP manufacturing, upstream cell culture production, downstream purification, bioconjugation, stability testing, and aseptic fill and finish. We even offer connections to our strategic partner networks for cell line development and other services. Our capabilities over such a large breadth of specialized services means we provide our clients with the solutions and support their project needs when they need it."

GBI’s CEO Darrin Schellin says, “We’re an end-to-end CDMO, simplifying the process and speed to and through the clinic while maintaining comprehensive communication and transparency, flexibility, and agility that our clients need. We have deep experience with complex biologics, having successfully produced various classes of DS and DP, not only antibodies but also ADCs and many other bioconjugates (including theranostics, radioimmune conjugates, photoimmune conjugates, antibody–peptide conjugates, vaccine conjugates, and others), bispecifics, Fc fusion proteins, recombinant proteins, cytokines, enzymes, growth factors, extracellular vesicles, exosomes, biosimilars, and biobetters, all from our facility in Florida, USA.”

What Sets GBI Apart?

“At the end of the day,” says CEO Schellin, “in this age of high innovation, complex, high-tech products, stretched supply chains, and geopolitical risks, GBI is built to help its clients simplify their product supply chains by providing technology, analytics, GMP drug substance and GMP drug product manufacturing, all within one over-arching relationship and from the same site in Florida. And while we’ve worked with large companies, we do this particularly well for those smaller, nimble, highly innovative companies who need a partner that intrinsically understands them. That is our sweet spot, what is unique and truly sets us apart.”

Schellin adds, “The next several years are going to mark a significant period of growth for us. GBI is launching a brand-new, fully integrated cGMP biologics facility that will expand our capabilities, with multiple bioreactor manufacturing trains ranging from 200 L to 2000 L, and make it easier and faster than ever to work with GBI, no matter the scale or stage of your project.

“We thank our clients for their continued and unwavering support. Our committed team is on a journey to commercialize our clients’ products as we move GBI into a late-stage clinical and commercial manufacturing focus. We have a cultural commitment to meeting the market’s expectations, and our very experienced scientists and engineers are dedicated to solving our client’s problems every day by shepherding their products toward the success they and their patients are waiting for.”