By Joe Hoff
Preparing drug products for tech transfer can be a daunting task. Traditional process development practices tend to be labor intensive, difficult to scale to a manufacturing environment, and gathering the critical process data to make informed decisions can be a challenge. This article describes how the advantages of AST's GENiSYS® system can streamline the tech transfer process by enabling efficient drug development activities and process data collection.
Process development engineers face a number of challenging tasks when it comes to determining the correct containers and manufacturing processes best suited for their drug products. Multiple factors are considered in order to optimize product stability, sterility, the primary container and manufacturing variables; all influence the overall efficacy of the drug. Understanding and optimizing these parameters is an essential part of the process required to get the drug product from the lab to manufacturing. This process is commonly referred to as "tech transfer".