Bridging the Divide – Streamline The Process Development & Tech Transfer Process
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”.
Traditional Process Development Challenges
Historically two of the biggest challenges that have to be overcome before tech transfer can occur are: developing relevant processes that can scale to higher volume production, and second collecting key process data from these tests in order make crucial process decisions. Commonly R&D and development engineers rely upon manual or simple semi-automated approaches to perform bench scale tests that mimic manufacturing operations such as filling and stoppering. However, these techniques often don’t scale well to a production setting and collecting critical process data is a tedious manual process prone to error. In order to bridge the information and process gap between development and manufacturing, flexible and automated platforms that replicate scaled up manufacturing processes is essential to streamline the overall tech transfer process. Streamlining this critical activity is key to getting products to patients faster.
Data Driven, Scaleable Processes Facilitate Efficient Tech Transfer Process
AST’s GENiSYS® system was purposefully designed to alleviate many of these development challenges by automating key process and making critical process data readily accessible. As an automated platform, GENiSYS® replicates the manufacturing processes used on typical aseptic production lines for processing vials, syringes, and cartridges. Its control system is recipe driven providing a high degree of process flexibility and parameter options that can be manipulated for process experimentation. Further expanding process capabilities the system integrates with multiple pump options and an automated in-process fill weight control system (IPC) to provide accurate and gentle dosing of each filled container.
To collect process data during operation the system’s Electronic Batch Reporting (EBR) system actively captures key process information that can be later exported for further process analysis. Once the process is fully developed and defined the EBR can print out a formal batch report that can be provided to manufacturing with all the relevant process information needed to effectively produce the drug product.
By combining automated scaled-down manufacturing processes, flexible operation and a process data collection system GENiSYS® can simplify the drug development process and streamline the tech transfer process. To learn more about GENiSYS® and its capabilities click here.