GRADE C INJECTABLE DRUG PROCESSING
Injectable drugs must meet high standards of quality, purity, and sterility. Our Grade C suites allow us to develop injectable drug products that can be terminally sterilized after manufacture. This permits a high guarantee of product sterility with heat, gamma, or e-beam exposure. All injectable drug processing is conducted in our Grade C, cGMP facility, which has been inspected by both the FDA and the European Union Quality Personnel.
TERMINAL STERILIZATION VS. ASEPTIC PROCESSING
Terminal sterilization is a convenient, cost-sensitive alternative to aseptic manufacturing. Aseptic manufacturing involves separate sterilization processes for each component of the product being manufactured. As the number of variables increase, so does the chance of product contamination and cost. With terminal sterilization, only the complete final product is sterilized. This decreases development time and expense.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.