Abstract

Current Technical and Regulatory Topics in Formulation and Product Development of Biologics

Satish Singh, Head, Lonza Inc

Sterile biological injectables are an increasingly important part of the therapies being developed for serious unmet medical needs. Although sterile parenteral products have been around for a long time, the technical and regulatory requirements for these products are continuously increasing, both as technology improves and as the standards are raised for safer products. This presentation will cover some recent developments in these areas.