Aseptic Filling Operations – To Keep In-House Or Outsource?

For decades, competitive innovations have been driving the sizes of devices smaller and the prices lower. This has been clearly achieved in computer tech with advances in microchips, and the same has been developing in the biotech equipment industry with both analytical test equipment and drug manufacturing equipment, making them more accessible to startup biopharmaceutical companies. Are aseptic filling technologies moving in the same direction? For some startup companies, the advancement of small, aseptic filling equipment that fits on a benchtop seems like a great entry into an operation that typically requires automated filling lines in large, dedicated portions of a cleanroom facility. With an ever-increasing number of Phase 1 and Phase 2 clinical trials, especially in personalized medicine, startup biopharmaceutical companies are choosing to invest in their own smaller filling equipment. Manufacturers such as Bausch and Stroebel, Bosch/Syntegon, and AST, that are renowned for the top of the line aseptic filling lines, are now offering benchtop filling, sealing, and closing systems. However, the majority of these smaller systems are manually operated. This poses dramatic sterility risk to the drug product, as well as major challenges for implementing this equipment from a quality perspective. While the personalized medicines that these new companies target are revolutionary, manual aseptic filling is clearly a step backward, and establishing in-house filling is a costly proposition.