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Gene Therapy Process Development

Scientist working on gene therapy in laboratory

You need a partner with a proven track record of advancing gene therapy product development and manufacturing, and the ability to adapt to your needs. As your trusted expert in life science, we provide optimized viral vector manufacturing platforms, packaging cell lines, media and reagents, characterization tools, and testing – all required to tackle the bottlenecks of gene therapy commercialization.

Our Gene Therapy Process Development Services allow you to:

  • Accelerate successful research into scalable, industrialized processes
  • Increase patient access through cost-effective, robust manufacturing
  • Remove subjectivity and operator error through closed and automated processes
  • Reduce the time to bring your therapy to clinical trials and commercialization, based on our technical expertise and knowledge transfer

Process Development

Leveraging our in-house expertise, we offer a complete range of process development (PD) services to improve yield and quality of your viral vectors. Our PD capabilities include different upstream bioprocessing and downstream purification approaches involving various virus types and diverse modes of adherent or suspension cultures. The breadth of our experience allows us to develop robust production processes to move your gene therapy products quickly through clinical trials and to commercialization.

Technical Transfer

We have established a full tech transfer team to ensure successful knowledge transfer and scaling-up of developed production/purification processes for cGMP manufacturing. The tech transfer team delineates acceptance criteria for engineering and cGMP programs, working collaboratively with our manufacturing team and clients. We have averaged more than twenty new tech transfer projects annually and have helped clients achieve faster speed-to-market.

To learn more about our Process Development Services for gene therapy manufacturing, contact us today.

Related Product Resources

Article: Three Cost Modeling Insights to Reduce Gene Therapy Manufacturing Cost
Article: Avoid Costly Process Development Mistakes
Article: Avoiding Costly and Time-consuming Mistakes in Gene Therapy Process Development
Article: Considerations for Bioreactor Process Development and Scale-up for Transient Transfection-based Lentivirus Production in Suspension
Article: Considerations for Development of a Platform Lentivirus Harvest Clarification Process for Cell and Gene Therapy

Article: Process Development is Key to Patient Success
Article: Process Development for Viral Vector Manufacturing
Article: Scaling Up Your Viral Vector Therapy
Article: The Importance of Scalability in Viral Vectors

Our extensive expertise and manufacturing experience make us an ideal partner to advance and translate your work to gene therapy success. Connect with us today to discuss your specific application.

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The Mobius® Bioreactor family includes the bench scale (2 mL and 3 L), pilot, clinical and commercial manufacturing (50 – 2,000 L) single-use bioreactors that enable cell culturing capabilities from early process development through commercial batch production.
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Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
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Growing viral vectors for new gene therapies poses complex upstream decisions about raw material sourcing, cell culture media preparation, filtration, transfer, storage, and point of use. Choices made upstream can have a large impact on the downstream process.
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Demand for new gene therapies is challenging manufacturers to accelerate development. By replacing legacy purification technologies with more scalable alternatives, downstream operations can produce greater economies while delivering higher yield and throughput.
Viral Vector Formulation, Final Filtration and Filling
New gene therapies must be formulated as a unique response to regulatory requirements, optimizing downstream products and processes to achieve reproducible product quality, safety, yield, titer, and purity.
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Viral Vector Contract Testing, Development, & Manufacturing Services (CTDMO)
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