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

Life Sciences, Pharmaceutical, Pharma Manufacturing & Supply Chain, Commercialization & HEOR,
  • Thursday, April 26, 2018

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.



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.

Message Presenter

Who Should Attend?

VPs, Directors and Managers of:

  • Manufacturing
  • Operations
  • Quality
  • IT

What You Will Learn

  • How cell and gene therapies have evolved
  • What challenges are facing the industry as it grows
  • Which tools to consider on the road to product approval and launch

Xtalks Partner


The world’s leading pharma & biotech MES.

Werum IT Solutions is the world’s leading provider of software for production control in the pharmaceutical industry. We develop best-in-class IT solutions for the majority of the world’s top 30 pharmaceutical and biopharmaceutical companies around the globe, and also for many regional and mid-sized enterprises.

Our manufacturing IT solutions help boost your production performance and improve quality and compliance – paving the way to operational excellence and leaner manufacturing.  With PAS-X, Werum offers a mature standard software product for the highly regulated and batch-oriented process industries. The PAS-X MES provides out-of-the-box maximum standard functionality for all applications in the pharmaceutical and biopharmaceutical sector. Companies using PAS-X benefit from lean production and operational excellence.

Business benefits:

  • Increase process efficiency
  • Improve production quality
  • Monitor and boost manufacturing performance
  • Help meeting compliance requirements
  • Reduce time to market

Media Partner


PharmaCompass is the one-stop, pharmaceutical information platform developed for professionals to make your strategic business decisions. It’s your free-access, integrated global database with detailed regulatory information on products and companies. The PharmaCompass’ team directly connects buyers to the right contacts at the suppliers without getting involved in commercial transactions.

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