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Update to Avantor’s response to the coronavirus (COVID-19) pandemic

Final fill for gene therapy

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.

Explore solutions for final fill of gene therapy

Single-use solutions

Biopharma Production Chemicals and Excipients

Bioprocessing facility support

Assays

Explore product choices for final fill for gene therapy

Ready to Maximize Lab Efficiency?

Our Bioprocessing Solutions team can help you streamline your recombinant protein processes!

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