Goodwin Biotechnology is becoming GBI, but that’s not the only significant change for this CDMO — they are also 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 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 SolutionTM 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?
Often, clients who start with small-scope work end up working with GBI over the long term, says Associate VP Manufacturing & Technology Andrew Majdoch. “We do get approached just to do one facet or one piece of development or a proof of concept. After being successful in these activities, it typically grows into a bigger and longer relationship with that client. They come back to us with larger work scopes and different projects for us to execute. We’re highly focused, refined, and have a lot of experience in what we do. And we do it well.”
“We take a holistic approach to the activities based on our experience and really educate our clients, who are often small to mid-sized companies, including “virtual biotechs,” that need CMC-related expertise, as we go through the process with them, teaching them about the why, where, and how things need to be done,” explains Schellin, “Our infrastructure and agility allow us to start both early- and late-stage projects faster, and our expert teams rely on transparent and proactive project management to help make that happen as quickly and efficiently as possible.”
Sesay says, “We thrive in our ability to predict at-scale GMP needs while developing processes early in the cycle and focus on our understanding and control of critical quality attributes and other important considerations, including scalability, process economics, and compliance — which are all requirements, as we are a highly regulated organization. We’ve participated in over 50 successful IND filings with the FDA, the EMA, and regulatory authorities in Canada, Asia, and elsewhere.”
Majdoch adds, “Our facilities are highly compliant and fit for purpose and our quality systems are phase-appropriate, which provides us the unique ability to efficiently handle early-stage as well as late-stage products with the quality compliance that each requires. This has ensured that we’ve undergone many successful audits and inspections by clients as well as the FDA."
“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.”
What Can You Expect from Working with GBI?
Even as GBI grows, the company is dedicated to operating around the guiding principles established within the company decades ago. Formed from the Goodwin Institute for Cancer Research in 1992, GBI has always approached its work with the goal of keeping patients in mind from the start. The company’s Single Source Solution™ has been designed with that intention at its core: finding the fastest and most reliable, regulatory-compliant, and effective path to aseptic fill and finish of the final biopharmaceutical product so that it can help patients as soon as possible — without ever sacrificing quality.
“We work backwards,” says Meek of GBI’s methodology, “We look at the process economics. We look at the compliance level. We look at the scalability. We anticipate the reaction times. Ultimately, how many multigrams to kilograms are you going to need for your clinical studies? Will you need 10 kilos for commercial launch in a few years? We never lose sight of the late stage, which is the key to successfully understanding and developing the product and the process from the tech transfer through clinical trials and beyond, to commercial manufacturing. Our experience makes that transition relatively easy, instead of it taking years.”
“We provide clients with a transparent and almost real-time experience working with us,” says Amita Quadros, Ph.D., Associate VP of Client Services. “Our engagement model and truly consultative approach supports clients that know what they want, but also those that are not quite sure. We provide flexibility within our project-execution model, which is very valuable for clients who are used to an industry notorious for rigid and inflexible ways of doing things.”
“Our expert teams will support your project from process development through manufacturing and until your drug vials, syringes, or cartridges are ready. We will also ship them for you,” adds Quadros, “and we do it all with agility, flexibility… and a smile!”
Concludes Schellin, “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.”
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