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mAbs Formulation and Final fill 

Progressing from the bulk drug substance to the final injectable drug product requires products like our J.T.Baker® line of excipients including surfactants, stabilizers, and bulking sugars. Avantor products meet quality and performance specifications that ensure product stability, solubility, and bioavailability.

mAbs Formulation and Final fill | Avantor

ISO-certified environments critical to final fill

To meet final fill 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 offer a range of excipients that are used in drug product formulation—including adjuvants, stabilizers, preservatives and bulking agents – as well as, final packaging vials, and stoppers— and other critical materials for final fill step. Our production water used in drug product manufacturing and as a diluent, which is processed and meets USP Water-for-Injection (WFI) testing requirements.

Explore product choices for final fill for mAbs

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With cGMP and cGDP chemical and excipients manufacturing, see how Avantor’s offerings can help speed time-to-market.

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Learn how Avantor is the only open-architecture provider of single-use systems to customers around the globe.

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Learn how Avantor Services bioprocessing specialists can help optimize your upstream and downstream operations.

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Avantor’s environmental control solutions include our complete product line and CE specialists with ISO and IEST protocols training.

Explore product choices for final fill for mAbs

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J.T. Baker® Amino Acid range

De-risk your supply chain with Avantor’s US country-of-origin and ChP compliant J.T.Baker® Amino Acid range.

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Related content

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Most monoclonal antibodies (mAbs) are developed with low protein concentrations, and typically delivered to the patient in liquid form via injection or intravenous infusion (IV). However, there are a growing number of indications that prefer intramuscular or subcutaneous injections - mainly so that a patient can self-administer the drug at home and reduce hospital stays and/or treatment costs, increasing patient compliance.

Ready to maximize production efficiency?

Our Bioprocessing Solutions team is here to help.

Yes, let's get started!