Since the 1990’s cell and gene therapies have offered new hope to patients suffering from rare and difficult to treat diseases. The reliance on specialized equipment and strict regulations has created barriers to becoming fully digitized in the manufacturing process. To satisfy stringent regulatory requirements, exhaustive paper documentation became the status quo across the Advanced Therapies industry. But as more therapies are exiting the development pipeline in the fastest growing market in the biopharma industry, more companies are looking for ways to streamline their operations – while maintaining good manufacturing practice (GMP) compliance. When producers make digitalization a priority during tech transfer, they can more quickly take advantage of automation systems to achieve these goals.
In fact, the optimal automation solution can provide significant operational flexibility and greatly reduce the effort on the receiving end of tech transfer. For advanced therapies, a manufacturing execution system (MES), like FactoryTalk PharmaSuite® or PlantPAx® can consume the digital data generated during tech transfer – and ease production management and compliance. By integrating production systems and enterprise resource planning (ERP) systems, producers can electronically track patient or donor cell samples, raw materials, and equipment. These integrated systems also provide continues process verification (CPV) to ensure processes are in a state of control.
Just as important, an MES automates and enforces adherence to established standard operating procedures (SOPs), thereby controlling both the recipe and the workflow. This is a tremendous benefit in the early state of an evolving industry like Cell and Gene Therapies and especially with autologous therapies where processes can be highly manual and require skilled operators.
Laying the foundation to prioritize digitalization early in the process of manufacturing is critical in this rapidly growing field to improve patient outcomes. Find out more about ATMP manufacturing and how Rockwell Automation can help you achieve desired outcomes here.
This blog is adopted from the whitepaper “Transforming Cell and Gene Therapy Manufacturing”. Download the free whitepaper to get an in-depth look at how digitization can combat common manufacturing challenges and improve your speed to market in the CGT environment.
