Optimized Development of Biologics Utilizing Innovative Advanced Aseptic Processing

Aseptic filling of injectable products is an extremely complex process and over the last several years the challenges in the process have manifested into recalls and supply issues. A significant amount of effort has been spent by the industry evaluating technologies to help minimize the risk, and reduce variables in the process to drive change.

One such technology that addresses the root cause of these issues is ADVASEPT™ technology, a glass free injectable filling platform that leverages blow fill seal technology. The technology has the following advantages which drastically reduce the risk of microbial contamination and foreign particulates:

• Leverages an automated forming and filling of the vial
• Reduces variables and eliminates human intervention

In addition to the improved process, the technology delivers a glass free primary container closure for which the biotechnology industry has expressed a strong interest. This transition to plastic vials has the potential to reduce surface interaction of the protein, reduce breakage concerns, and eliminate the delamination issues associated with the traditional glass vials. However, the selection of an appropriate plastic vial format compatible with protein therapeutics requires knowledge of the vial component chemistry and its impact on protein safety and efficacy.

In this presentation, Catalent's expert Dr. Dipesh Shah will discuss through case study examples the compatibility of a model monoclonal antibody (mAb) formulation in glass and compare it with ADVASEPT™ vials (plastic vials) containing uncoated stoppers. Attendees will gain a fundamental understanding of the advanced aseptic processing utilizing Blow Fill Seal Technology (BFS) and how this innovative technology can be applied to the development and manufacturing of biologics in plastic vials.