Aseptic processing to maintain the integrity of ancillary materials for cell therapy manufacturing

Aseptic processing is one of the most critical steps in the production of biopharmaceuticals. It is uniquely challenging in its requirements for personnel and facilities. Avoiding contamination requires careful planning, effective personnel training, attention to detail on the part of technicians, and specialized facilities and equipment. These activities, skills, and facility features are necessary to

Manufacturing Scale Up

The problems that arise when scaling up from small research batches to pilot-scale production to large-scale manufacturing aren’t always what you might expect them to be. While the concentration of the components in the formulation may not change, plenty of subtle idiosyncrasies noticed in the research phase can become huge hurdles on the commercial end

From sterile filling to custom manufacturing: How Akron’s unique services and capabilities can work for you

Akron’s sterile manufacturing facility, presented here before, enables the unique preparation of products within a fully aseptic manufacturing environment, including sterile filtration and container-closure filling. And while this allows Akron to manufacture cGMP-compliant, sterile-filled cytokines and ancillary materials for cell therapy, Akron also extends these capabilities as services to serve the industry: Owing to our unique facilities, our manufacturing capabilities are among