Recombinant proteins formulation and final fill

Progressing from the drug substance to the final injectable drug product requires final packaging vials and stoppers that meet a number of quality requirements.

ISO-Certified environments critical to final fill

To meet packaging quality requirements, products must be prepared in an ISO Class 5 environment and meet USP71, USP85 and USP758 requirements to be sterile, pyrogen-free and particulate-free. They must also be validated for use in storage of frozen or lyophilized drug product and for compatibility with the protein and excipients in final formulation.

Not only do we offer a large range of excipients that are used in drug product formulation — including adjuvants, stabilizers, preservatives and bulking agents — but our scientists can support your formulation development. We also offer production water processed and meeting testing requirements in accordance with USP Water-for-Injection (WFI) regulations used in drug product manufacturing and as a diluent.