White Paper

Six Strategies To Improve Your Approach To Fill-Finish Manufacturing (Part 1)

Source: Emergent BioSolutions Inc.
Clean room

The global market for biopharmaceuticals continues to grow at a rapid pace, with a 9.5 percent compound annual growth rate (CAGR) predicted over the next eight years. This translates into more than $500 billion in projected growth; thus, it is no surprise that biopharma manufacturers around the world are investing heavily in new facilities, technologies, and pipelines for the manufacturing of biologic products.

Even so, the need to prevent contamination places stringent handling and packaging requirements on biopharma manufacturers. The sterilization of equipment often requires steam autoclaves as well as dry heat, and may even include treatment by irradiation. In fact, the U.S. Food and Drug Administration (FDA) mandates that all containers used in a sterile manufacturing process must be sterilized prior to contact with the drug product itself; and the agency has recently recalled a number of pharmaceutical products for failing to comply with this requirement.

For this reason, a growing number of biologic manufacturers are turning to new aseptic fill-finish technologies, including blow-fill-seal systems and single-use equipment. Even as these new technologies see increasing adoption, the core demands of fill-finish processes remain the same: to keep equipment and formulations free from contamination and to package the product in a way that preserves the biochemical conditions most conducive to the safety and efficacy of each biopharmaceutical product.