GMP Cell Manufacturing and Process Development

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Cell Processing and Engineering Services

Is your CAR or TCR therapy ready for the next step in scale and production? We can take your current process and get it ready for GMP manufacturing in under five months. From large scale isolation to cell engineering steps to activation methodologies and culture vessels to final fill and finish. Our new clean room facility provides in-house process development for any gene modified therapy, cGMP patient processing for Phase I and Phase II clinical trials, and cGMP manufacturing of iPSC cell lines.

 

Expertise You Need, Flexibility You Want

Our mission as your partner extends beyond an optimal process for your therapy. From the onset we work with you to build in the flexibility needed to meet the demands of scaling to commercialization. If you are ready for the next steps, set up a free consultation today.

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Process Development

Partner with our experts to develop an optimized process to take your CAR or TCR therapy to the clinic.

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Contract Development & Manufacturing

CDMO services for your gene modified therapy to process you phase I and phase II clinical trials.

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Process Development Services

Early Stage Process Development

Are you GMP-ready? We will work with you to ensure your process is:

  • Optimized for cost and repeatability of performance
  • Capable of dual sourcing for critical components
  • Future proofed for Phase I and Phase II studies
  • Built with key flexibility points to avoid non-conformity

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Contract Development and Manufacturing Organization (CDMO)

Our ISO 7 cleanrooms are fully operational and open for business. Are you looking for a CDMO to process your Phase I/II clinical trials or to manufacture GMP-grade engineered mammalian cells? We offer process development services for any gene modified therapy, cGMP patient processing for Phase I and Phase II clinical trials, and cGMP manufacturing of iPSC cell lines.

Our state of the art 6,000 square foot cGMP facility is strategically located in Minneapolis, MN, USA. Our US-based suites currently comply with ISO Class 7 (Class 10,000) classification to meet U.S. requirements.

Shared Goals of our Cell Processing and Engineering Services

We are exceptionally cognizant of the need to get your therapy into the clinic. Our non-viral gene transfer platform means we can have you in the clinic in four months. We are not only fastidious about patient safety, we are keenly focused on helping you bring down the cost of cell and gene therapies. With our simplified and lean services, we can provide your therapy with a quicker pathway into the clinic than any other CDMO out there today, without sacrificing quality. Rather than working with multiple vendors, our new clean room facility means R&D Systems can offer in-house process development for any gene modified therapy, cGMP patient processing for Phase I and Phase II clinical trials, and cGMP manufacturing of iPSC cell lines.

Let us help you achieve:

  • A four-month pathway to gene modified therapies
  • Reduction in materials costs with gene transfer reagents that are 40% the cost of viral-based reagents
  • Reduction in your patient cell processing costs through competitively priced CDMO services

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New Clean Room Facilities

  • 2 Clean Rooms
  • 575 ft2
  • 2 Development Labs
  • 1 In-House Quality Control Lab