Our platform for cell and gene therapies enables delivery of GMP lots, QC tested, and released faster and with greater predictability.

Platform Therapeutic Compatibility

Viral Vectors like AAV and Lenti

Viral and Non-Viral Cell Therapies

Platform Components

Strategic focus on all process inputs designed to fast-track timelines.

Supply Chain Assurance

Ensures high demand raw materials and supplies are in stock and readily available, paving the way for rapid deployment.

Accelerated Program Start

By streamlining the early stages of the production program with qualified materials, pre-trained staff, template batch records, platform testing plan, and GMP Readiness, we are able to ramp up to GMP production faster than a traditional tech transfer.

Integrated GMP Manufacturing and Testing

Accomplished through innovative project engineering and over three decades of release testing experience, we have been able to compress timelines with our integrated approach enabling swift delivery of GMP product.

Scalable and Transferrable

Built to facilitate expedited entry to clinical trials, the platform can also be adapted with the help of our process and analytical development experts to meet the demands of a commercial launch. Thinking about launching an advanced therapy in another geography? Contact us to discuss our GMP manufacturing capabilities located in China.

Platform Advantages:

  • Accelerates development and manufacturing timelines
  • Augments unrefined processes – ideal for conserving financial and personnel resources
  • Reduces outsourcing complexity – end to end solution provided by one vendor
  • Alleviates industry bottlenecks such as material sourcing/supply, manufacturing/testing capacity, and talent shortages

 

Are platform modifications possible?

Timelines will be shorter when utilizing our defined criteria, however, our platform can accommodate certain changes with the assistance of our Process and Analytical Development teams. The best way to determine if your process falls into either a platform, hybrid, or custom would be to schedule a detailed discussion with our technical team.

Ready to discuss feasibility and timelines?

Speak to our technical team.

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