Because they occur after two highly engineering, and science-driven phases of biomanufacturing – expression and purification – biopharmaceutical fill and finish processes have not received the respect traditionally that they deserve. Yet of all competencies associated with bringing biopharmaceuticals to market, fill and finish arguably are the most specialized.
This eBook reports on the technical and operating challenges impacting the latest formulations and devices including: outsourcing, contamination, standardization (pre-filled syringes), lyophilization, and serialization.
Here is an excerpt:
An Easy Decision: Contracting Out
A 2016 survey by BioPlan Associates noted that although outsourcing is growing only modestly overall — in the 2–4% annual range — about three-fourths of respondents indicated that fill–finish was part of their outsourcing strategy (1).
“Small biotech companies are fueling much of that growth [in outsourcing],” observes Peter Soelkner (managing director at Vetter in Ravensburg, Germany). “These companies are highly risk-averse, particularly in early clinical phases, when they hope to attract investors or create outlicensing opportunities.” That leads to the early decision to engage with an experienced contract manufacturing organization
(CMO) for fill–finish.
“For many drug developers, selecting the right fill–finish CMO will be critical. Sponsors usually get only one chance to get it right,” Soelkner says. And he provides a must-have checklist for qualifying fill–finish contractors:
• Experience with relevant compound classes
• Strong regulatory expertise
• Creativity and flexibility to meet evolving demands
• Strong commitment to quality standards
• Financial stability
• Compatible corporate culture.
Outsourcing fill–finish is an easy decision because very few biopharmaceutical companies have the resources or the product stream to justify constructing a dedicated filling plant. “This niche is complex and highly specialized,” notes Paul Ruther (director of fill–finish at Ajinomoto Althea in San Diego, CA). “Doing it right requires special facilities, equipment, and a tremendous amount of operator training.”