Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product

A white paper by Alex Mello, Director of Project Management, Manufacturing

Biopharmaceutical manufacturing is the production of protein-based therapies which include recombinant proteins, monoclonal antibodies, and vaccines. With such an extensive repertoire of products there are many aspects of testing specific to the type of product being assessed. This whitepaper 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 life cycle: going from the purified bulk drug substance (“PBDS”) to the sterile final drug product (“FDP”). To download the paper, please fill out the form below. (Microtest respects your privacy. We will not give your email address to third parties or send you unwanted email.)