KBI Biopharma offers cGMP manufacturing and release of Active Pharmaceutical Ingredient (API) for use in pre-clinical and Phase I and Phase II clinical trials. We have extensive experience in cGMP manufacturing, testing and release of drug substance – expertise that ensures your product is delivered according to planned timelines.

Our clinical manufacturing capabilities include both bacterial and cell culture based protein products. These capabilities, along with our extensive process development experience, ensure a smooth, delay-free transition and successful small scale manufacturing.