How Digitalization Helps Cell And Gene Therapy Manufacturers Overcome Operational Challenges

Life science companies aiming to capitalize on the expanding global cell and gene therapy (CGT) manufacturing market will require cutting-edge tools and technologies.

However, many of these organizations are insufficiently equipped to meet the high safety standards, rapid production needs, and strict traceability requirements that CGT manufacturing demands. To successfully participate, they must adopt a process that ensures compliance to a recipe or Master Batch Record (MBR), provides verifiable proof of compliance, securely records all manufacturing data to prevent alteration or deletion, and archives this data for tracking, auditing, and continuous improvement.

Traditional protocols and methods are inadequate for this challenge, so manufacturers must find ways to optimize processes for fast and reliable production. Continue reading to discover how digitalization can offer better control and increased speed for cell and gene therapy manufacturers.