Final fill for recombinant proteins
Progressing from the drug substance to the final injectable drug product requires final packaging vials and stoppers that meet a number of quality requirements.
To meet these 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.
We also offer a range of excipients that are used in drug product formulation — including adjuvants, stabilizers, preservatives and bulking agents — and 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.