Aseptic fill/finish is a crucial step in biopharmaceutical manufacturing, as it refers to the last step before a parenteral drug is packaged and ultimately delivered to the patient. More specifically, it is the process by which biopharmaceutical manufacturing companies transfer a filtered sterile drug product through a filling needle into an aseptic vial. If the drug is not sufficiently stable as a liquid formulation, lyophilization can be an important part of this process to keep the drug product as a lyophile and enhance shelf life. The need for reliable, sterile pharmaceutical manufacturing processes for parenteral drug products is paramount to deliver much-needed vaccines and other injected, infused, and implanted drugs to people worldwide.
The global vaccines market was forecast to boom even before the COVID-19 pandemic, estimated to reach a value of $100 billion by 2025 (Research & Markets, 2019). To help sustain this expansion, experienced contract development and manufacturing organizations (CDMOs) with strong regulatory and technological expertise will be critical. Read our whitepaper to learn more.
