Cell Therapy and Gene Therapy: A Case Study On Scaling Up For Commercial Manufacturing

There are two new players on the biologics industry block – cell therapy and gene therapy. Join our featured speaker for a discussion of how cell and gene therapies differ from pharmaceuticals and learn about the challenges to achieving commercial manufacturing.

Imagine you are an up-and-coming cell therapy company. You have gone through the exploration phase, with all of its complexities and are in the process of finalizing a breakthrough treatment. At this point, you begin to consider how you can get that cell therapy to a commercial manufacturing setting, with all the tools and systems in place to support the process. The tools and systems that worked well for you in the past may not necessarily work moving forward. There will be a need to consider new tools and new ways of doing things within the company to be successful moving forward.

As the vision of achieving commercial manufacturing becomes clearer, there have to be some major considerations on ways to improve and streamline the manufacture of cell and gene therapies. Some of the considerations include:

• Cost of production
• Ability to ensure that these lifesaving drugs are delivered to the patient on time
• Elimination of paper from the shop floor
• Preserving the chain of identity throughout the entire process
• Reduction of manual processes to reduce human error and the effort required to scale
• Increased quality through standardization of processes
• Coordination of supply chain tracking
• Process optimization – product to patient feedback loop
• Raw material quality – how to control for differing patient health samples
• Regulatory filing

A unique requirement for cell and gene therapy companies is that the development processes up to commercial manufacturing are not sequential as with other industries. It is a continuously evolving process, where updates are consistently being made in a positive feedback loop. Even after a path to manufacturing has been realized, the improvement process continues with major considerations still at play.

Join us as we walk along the journey of two companies who started from similar beginnings but diverged in the decisions they made on how to scale into commercial manufacturing for their respective cell and gene therapies. The decisions they made around these major considerations and the tools they used to address them will have a lasting impact on the success of their treatment, from scale-up of a developmental therapy to long after the therapy has been approved and is used in patients.

Speaker

Mucahit Agirtmis, MES Consultant, Werum IT Solutions

Mucahit Agirtmis is a Sales & Business Consultant with Werum IT Solutions. He has a background in Chemical Engineering with a focus in Bio-manufacturing. He works with the sales team to establish strong relationships with customers based on knowledge of customer requirements and commitment to value (solutions, project and company expertise). Through his work as a consultant for our CAR-T customers, he has developed a unique understanding of the synergies between Werum’s Solution offering and the challenges facing the cell and gene therapy industry today.

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