A contract development and manufacturing organization (CDMO) provides drug development and manufacturing services to the pharmaceutical sector. In recent years, a variety of factors have fueled significant growth in the global pharmaceutical CDMO market. In 2021, this market was worth USD 183.62 billion and is expected to achieve a 7.29 percent CAGR over the next five years.
However, the CDMO industry needs to respond swiftly to challenges as biopharmaceuticals become more complicated. There is now a greater need for innovation and effective solutions to quickly and efficiently develop and manufacture these important biologics. Therefore, biologic CDMOs like Goodwin must be agile and flexible, bringing together professionals from multiple disciplines to find solutions that increase efficiency.
Darrin T. Schellin, CEO of Goodwin Biotechnology shared their success story.
Inception of Goodwin Biotechnology
Since 1992, Goodwin has been a CDMO focusing on specialized biologics, including antibodies (monoclonals, and multi-specifics), recombinant proteins, antibody drug conjugates (ADCs), radio-immunoconjugates, conjugated vaccines, fusion proteins, and stem cell-derived therapeutic nanoproteins. Typically, biologics have complex processes that are not amenable to scaling and manufacturing at the higher yields required. The complexities often cause delays, generate potential quality issues, and increase costs that jeopardize the entire campaign.
Goodwin has a history of successfully resolving these problems because they have highly skilled and experienced scientists who develop compliant, scalable and economical processes for manufacturing the biologic for early and late-stage clinical trials. As important, Goodwin has a specialized facility to manufacture those products under cGMP (current Good Manufacturing Practices), and in compliance with the FDA and other regulatory agencies.
Their Journey Towards Success
Since 1992, Goodwin has provided process development and cGMP manufacturing services for complex mammalian cell culture-based biologics. This impressive track record is driven by a balanced team of executives and highly skilled scientists who have significant expertise in biologic development and manufacturing. As a result, Goodwin continues to be approached by and work with companies that have the greatest innovations imaginable. These companies continue to drive Goodwin’s growth in terms of size, capability sets, compliance levels, and enhancing the quality of people that the company hires.
Trends in the Industry
The increase in outsourcing demand drives consolidation in the biopharmaceutical CDMO space. Companies have been acquiring smaller specialty firms and upscaling their operations, but changes often require the inherent ability to be flexible and responsive to customer needs to be lost. Further, the increased bureaucracy and overhead increase prices and extend lead times.
While fewer, but much larger-sized CDMOs are in this marketplace, Goodwin continues to remain independent and one of the smaller, more specialized CDMOs.
In addition, scientists are continually inventing new biologics that target particular diseases, and the therapeutics are becoming increasingly personalized for each patient. Some products may be designed to benefit a few hundred patients and the amount of product required is quite small. This “small” CDMO site suddenly becomes attractive for producing such medicines, and Goodwin is taking advantage of this strength.
While biologics are revolutionizing therapeutics, they are extremely complex to develop and manufacture, and often require several components to be brought together. As a result, CDMOs are relied upon to advance a company’s product from the proof-of-concept stage, process development, then cGMP manufacturing. As a result, instead of investing in brick-and-mortar facilities and acquiring many employees, the companies partner with CDMOs to develop and manufacture their biologic.
The challenge is to find a CDMO that can manage the whole supply chain. Goodwin maintains micro-scale development bioreactors through large-scale 500L capacity and is currently undertaking a facility buildout of three, state of the art, upstream bioreactors with dedicated downstream purification trains, including expanding capacity to the 2,000L scale, and a new fully automated sterile filling suite for vials and syringes, all designed to meet clients’ needs. By minimizing the complexities of the supply chain, clients can avoid delays, potential quality issues, and unexpectedly prohibitive costs, any of which can jeopardize the entire clinical campaign.
GOODWIN HAS DEVELOPED A PEDIGREE IN ELIMINATING THE MANUFACTURING RISK FOR INNOVATIVE, COMPLEX BIOPHARMACEUTICALS BY LEVERAGING NIMBLENESS AND A VAST EXPERTISE IN BIOLOGICS.
In short, Goodwin has developed a pedigree in eliminating the manufacturing risk for innovative, complex biopharmaceuticals by leveraging nimbleness and a vast expertise in biologics. For example, Goodwin offers bioconjugation, such as Antibody Drug Conjugates (ADCs), where a monoclonal antibody is linked to a payload (a chelating agent for radioisotope labeling supporting both diagnostics and therapeutic indications, an adjuvant such as Aluminum Hydroxide-Antibody conjugate, controlled substances protein vaccine conjugates, fluorescent dye or other ligand, radioisotope, dye, or even another antibody). The resultant compound targets specific cells, such as cancer, without harming healthy cells. These targeted therapies often require smaller batches of product, and Goodwin is well positioned to make this happen.
Mr. Schellin sees strong tailwinds in biologics and outsourcing will continue to remain strong to develop and successfully manufacture these biopharmaceuticals.
For three decades, Goodwin has blended its process development and manufacturing experience, with regulatory, product characterization, sterile Fill and Finish, and supporting analytical services. To date, Goodwin has completed nearly 500 biologic projects for over 150 satisfied clients and participated in the filing of over 50 Investigational New Drug (IND) applications with the FDA. And more than 80 percent of its business comes from existing or referred clients, which is a testament to the level of client satisfaction that Goodwin has worked hard to achieve and continues to enjoy.
Goodwin provides solutions that the market needs a biological CDMO with the breadth of services and capabilities all under the same roof while mitigating challenges to develop and manufacture biopharmaceuticals. With “Goodwin Delivers” as resounding client feedback, their Single Source Solu- tion™ uniqueness has helped Goodwin become the preeminent provider of high quality, cost-effective, flexible, and timely cGMP manufacturing solutions.
Not stopping there, they are taking the company to the next level by adding industry-recognized leadership with the recent appointment of a new CEO. In addition, they have recruited key executives in manufacturing operations, as well as quality and regulatory groups to enhance their scientific and technical capabilities. Next, Goodwin has significantly expanded their space by acquiring the campus which they previously leased near Fort Lauderdale. And, this year, they are expanding their capabilities within this facility to manufacture commercial biopharmaceutical supply.