Testing from drug substance to final product

From purified bulk drug substance to sterile finished product, routine sampling and testing throughout the process ensures a quality end result.

By John Dobiecki and Alex Mello, Microtest Laboratories

Biopharmaceutical manufacturing is the manufacture of protein-based therapies, which include recombinant proteins, monoclonal antibodies, and vaccines, to name a few. With such an extensive repertoire of products, there are many aspects of testing specific to the type of product being assessed. However, there are typical tests that are universal for all these types of products, in addition to traditional synthetic pharmaceuticals (small molecules), that are performed during the manufacturing process.

This article will discuss the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer. Specifically, the focus will be on what many consider the most critical part of a biological drug product’s manufacturing lifecycle: going from the purified bulk drug substance to the sterile final drug product.

While it’s a given that no two products and processes are alike, the approach described herein provides a good general basis for establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities. While the focus is on processing of biologics, this approach is also applicable for the most part to small-molecule drug product formulation and fill/finish.

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