Goodwin Biotechnology, Inc.
Eliminating the Risk in Manufacturing Complex Biologics

Bringing biological products from concept to the market is arduous without the guidance of seasoned veterans operating in sophisticated facilities. Aside from the many manufacturing risks a company faces when advancing product candidates through development, creating an efficient manufacturing process that is robust and scalable to produce material for early- through late-stage clinical trials, then on to commercialization, all while selecting and managing a complex supply chain are vital areas that require significant attention. Achieving a perfect score on these fronts can be daunting while concentrating on costs and time. With the help of Goodwin, taking a biological candidate from its initial stages of pre-clinical development through to commercialization is an investment in a promising future for the product and the company.

Based in Florida, Goodwin is a biologics contract development and manufacturing organization (CDMO) that promptly sets itself apart in the market by being nimble and delivering robust biomanufacturing solutions since 1992. Goodwin proffers high-quality, cost-effective, flexible, and cGMP-compliant manufacturing solutions in an efficient and timely manner to produce complex biologic therapeutics for companies across the globe. Through its fully-integrated manufacturing flagship offering, the Single Source Solution, the company helps clients manage their biomanufacturing projects from discovery and pre-clinical work, process development, and cGMP manufacturing, supporting clinical trials through commercialization all in one location. “As an independent contract manufacturer, we have worked as a strategic partner with companies and institutions of all sizes, helping them navigate the challenges of bringing their biological candidate to market,” says Darrin Schellin, Goodwin’s CEO.

The Single Source Solution that Goodwin employs comprises a full range of mammalian cell culture development and manufacturing services to deliver monoclonal antibodies, multi-specific antibodies, antibody fragments, stem cell derived nanoparticles, recombinant and fusion proteins, Antibody Drug Conjugates (ADCs), radioimmunoconjugates, and other complex proteins.

The company streamlines and simplifies the creation of upstream and downstream bioprocesses to develop drug substances for proof of concept (POC) studies and clinical trials and provides aseptic Fill and Finish services. Biopharma companies can rely on Goodwin’s unique and unrivaled expertise in the development, validation, characterization, and commercial-scale manufacture of these complex biologics.

Over the last three decades, Goodwin has served more than 150 clients, bringing more than 500 varying biologic projects to fruition. Moreover, Quality by Design (QbD) is at the heart of everything the company does. Complementing and supporting their core services are assay development and qualification, analytical characterization and quality control (QC), and quality assurance and regulatory affairs (QA/ RA), which have manifested in more than 50 Investigational New Drug (IND) filings and building an enviable reputation for regulatory compliance. This, coupled with superior service, helps Goodwin meet and exceed its clients’ expectations.

Goodwin is pivoting from being a highly scientific early-stage biologic CDMO to become a vertically integrated commercial partner, focusing on meeting our customers’ needs and delivering to their highest levels of expectation

For instance, Goodwin recently engaged with a client to manufacture their bioconjugate for Phase III clinical trials. However, the process that was transferred to Goodwin tended to cause aggregation problems, and as a result, the material was not suitable for clinical use. Leveraging their process knowledge, the highly skilled development team at Goodwin analyzed the situation and informed the client of the challenges that limited their progress. Goodwin looked at different resins and columns, conducted small-scale downstream studies, generated numerous Proof of Concept batches, and recommended a proven process that eliminated the aggregation risk. Based on Goodwin’s development results, the client implemented all of the suggested process improvements, resulting in the successful execution of every manufacturing run that has been performed with the new process.

By helping organizations overcome their biomanufacturing challenges to bring the potential of their client’s products to the patient, the company is pivoting from being a highly scientific early-stage biologic CDMO to a vertically integrated commercial partner, focusing on meeting customers’ needs and delivering to their highest levels of expectation. While remaining a mid-sized biological CDMO to retain flexibility in delivering world-class biologicals, the company will soon be expanding its bioreactor capacity to a 2,000-liter scale while adding highly-skilled scientists, relevant technical infrastructure, and enhancing its development and manufacturing facilities.