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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.

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


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


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


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


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


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.

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