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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. Indeed, market research suggests that the global sterile injectables market will grow 11% annually through 2024 (ZionMarket Research, Jan. 2020). In this important white paper, the fill/finish experts at Piramal Pharma Solutions’ Lexington, Kentucky site provide insights into key components of aseptic manufacturing of parenteral drug products, including:
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