By Jon Best, Director, Business Development; Jeff Tremain, Director Business Development; Ted Tharp, Associate Director, Parenteral S&T; Gene Wloch, Director, Parenteral Products, Operations
Aseptic fill finish manufacturing is one of the final but crucial steps between biopharmaceutical development and patient care. Using carefully managed liquid filling or lyophilization processes for vials and syringes, drugs are filled into a safe, convenient delivery form ready to administer to patients. This process is especially critical for highly valuable biologic drug substances since, with vast amounts of time and resources invested upstream, any errors resulting in loss of product at such a late stage have the potential to be catastrophic.
One way to mitigate the risk associated with aseptic fill finish manufacturing of biologics is to partner with a contract manufacturing organization (CMO) demonstrating proven expertise in all aspects of biologics production. An experienced service provider will not only have designed fill finish operations to consider the inherent lability of biologic drugs but will be capable of completing fill finish biologics manufacturing at a scale suitable to meet demand.