Why Goodwin Biotechnology?
We recognize that one cannot understate the importance of selecting the right Contract Development and Manufacturing Organization (CDMO), because biologics manufacturing is a technologically complex, yet highly regulated process. Large complex protein structures are unstable and have a low tolerance for error. The best product can fall short or even fail if it experiences substantial delays in the development and manufacturing processes, and the slightest delay can lead to high opportunity costs from lost sales. We understand these issues and truly respect the significance of your decision, first to outsource, then to select the best CDMO. Your decision can make or break careers and even companies.
We Think You’ll Agree with these Selection Criteria
- Experience – Goodwin Biotechnology has nearly 30 years of experience as an independent contract development and manufacturing organization (CDMO) and over 18 years in pioneering Antibody Drug Conjugates (ADCs).
- Delivering On Time – The expertise of our highly skilled scientists have proven time and time again to provide solutions by anticipating and addressing challenges before they occur. This, coupled with our transparency (Learn more on Project Management page) and efficiencies, help ensure that timelines are maintained.
- Delivering On Budget – Our expertise with over 150 clients and almost 500 different biologic products assures that we will deliver your project on time and on budget- no surprises!
While meeting and exceeding these selection criteria is imperative, your CDMO partner needs to be flexible because the one constant in cell culture manufacturing is change. Therefore, a valuable consideration is to select a strategic partner who can anticipate the unexpected and proactively develop plans to address, or at least rapidly and cost-effectively overcome the challenge. At Goodwin Biotechnology, our staff has not only learned flexibility, but they honed their skills with over 200 years of industry experience combined.
Recognizing the challenges of manufacturing complex biopharmaceuticals, Goodwin Biotechnology stands ready to help formulate a customized strategic approach to your project with an emphasis on critical development, manufacturing, quality, regulatory, and characterization considerations.
The Importance of Quality by Design
Biopharmaceutical development and cGMP manufacturing processes are not without challenges. The complexity of potential development and manufacturing problems is directly related with the complexity of the molecule. As a result, the concept of Quality by Design (QbD) has been recognized by Regulatory agencies such as the FDA. Simply put, QBD is a systematic and science-driven approach demanding the application of process understanding (process parameters and process controls) and product knowledge (product specifications and product quality attributes) to enable the delivery of a “totality of evidence” that is extremely helpful in gaining clearance to market your biopharmaceutical candidate.
Goodwin recognizes that QBD in the biopharmaceutical industry is essential, so we integrate QBD in biopharmaceutical development of your project to ensure seamless scale up and robust cGMP processes for late-stage clinical trials and commercialization. The importance of this cannot be overstated. By focusing on QBD principles as early as possible in the antibody development process, the greater level of efficiency translates into lower costs and a faster route to market for your biopharmaceutical candidate.
Who Is Goodwin Biotechnology?
Goodwin Biotechnology offers a Single Source Solution™ aimed at producing the highest quality material possible. We are a full-service, customer-focused, integrated contract services provider with nearly 30-year history in cell culture bioprocess engineering and the development and manufacturing of mammalian cell culture-derived monoclonal antibodies, recombinant proteins, and vaccines, and over 15 years of bioconjugation experience and expertise. This makes us one of the most experienced and stable contract development and manufacturing organizations (CDMOs) in the world.
Moreover, our global customer base includes clients from North America, Europe as well as Asia, consists of companies ranging from academic institutions and biotechnology startup firms to large, established, multinational biopharmaceutical companies.
Enhance the value of your biopharmaceutical candidate
Contact us for more information on how Goodwin Biotechnology can enhance the value of your biopharmaceutical candidate.