Selecting a CMO in a Risk-Averse Environment

One cannot understate the importance of selecting the right CMO, because

• Biologics manufacturing is a technologically complex, highly regulated process.
• Large complex protein structures are unstable and have a low tolerance for error.
• Even the best product can fail if it experiences substantial delays in the development process.
• Even 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 CMO. It's a decision that can make or break careers and even companies.

Two important selection criteria are Experience and Flexibility. GBI has nearly 20 years of experience as an independent contract manufacturing organization (CMO), and we have developed into a world-class, fully integrated cGMP manufacturer of monoclonal antibodies and recombinant proteins for preclinical and clinical trials.

The Experience To Anticipate The Unforeseen

While a few decades of experience may be impressive, one 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 GBI, our staff has not only learned flexibility, with over 200 years of industry experience, we've also learned to anticipate problems and proactively address them.

Check out our latest FDA Establishment Inspection Report and / or hear what a few of our clients have to say and ask the hard questions.