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Cell Therapy GMP Manufacturing

Clinical and Commercial-Scale Manufacturing for Cell Therapies

Scaling a cell therapy from clinic to market requires a CDMO partner that not only understands the science but also offers the infrastructure, regulatory expertise and agile manufacturing capabilities to deliver seamless success at every stage. Minaris Advanced Therapies offers comprehensive GMP manufacturing for autologous and allogeneic cell therapies, spanning from clinical supply to global commercial product launches.

With a legacy spanning over 25 years and more than 7,500 GMP batches produced, we support our clients with clinical-grade manufacturing that seamlessly scales into commercial-ready systems, all under a globally harmonized quality model.

Whether you’re preparing for first-in-human or post-approval supply, Minaris brings the discipline and adaptability to deliver consistently, compliantly and with confidence.

FROM CLINICAL TO COMMERCIAL

GMP That Grows with You

Minaris offers phase-appropriate GMP manufacturing solutions tailored to the evolving needs of your therapy as it advances from early-stage development through licensure:

Early-Stage Clinical Manufacturing

Flexible cleanroom access, shared or dedicated equipment models and agile scheduling for rapid program onboarding and support for your local health authority submissions.

Late-Stage Clinical Manufacturing

Enhanced automation, increasing batch scale, validation-ready systems and robust supply chain integration to support pivotal trials and BLA readiness.

Commercial-Scale Manufacturing

Dedicated cleanroom suites, automated fill/finish, commercial QA/QC systems and global distribution infrastructure. Currently manufacturing licensed commercial cell therapies.

Built for Modality-Specific Requirements

We manufacture across a wide range of cell therapy types and engineering approaches, including:

  • Autologous T cell therapies (CAR-T, TCR-T, TIL, HPC and Treg)
  • Allogeneic CAR-T and NK cell therapies
  • Stem cell therapies (HSC, MSC and iPSC)
  • Gene-edited products (CRISPR, TALEN, viral vector-modified)
  • Non-viral and electroporated products

Global Manufacturing Network, Harmonized Execution

Minaris offers GMP manufacturing from three regions under a globally harmonized quality system in North America, Europe and Asia.

Our Network includes:

  • Commercial and clinical manufacturing facilities in Germany (Munich), the US (Philadelphia, PA and Allendale, NJ) and Japan (Yokohama)
  • Modular cleanroom suites for autologous and allogeneic manufacturing processes
  • Integrated aseptic fill capabilities (manual and automated)
  • Co-located testing and cell banking for process continuity
  • Suites that can be utilized in a ballroom configuration for high capacity

Each site operates on a unified way-of-working model to reduce revalidation risk, streamline tech transfer and enable seamless scaling as you grow across geographies.

Integrated Testing for Smarter, Faster GMP Execution

Minaris Advanced Testing builds analytical development and testing directly into our manufacturing workflows. Co-located QC labs eliminate delays in sample transfer, while harmonized assay platforms reduce variability and risk.

Our in-house services include:

  • Lot release testing (Safety, Identity, Strength, Quality and Purity)
  • In-process controls and real-time analytics
  • Stability and biosafety testing
  • Assay development, qualification and validation

We operate with full regulatory alignment and audit readiness, supporting both product and process validation testing for BLA and MAA filings.

Discover Our Full Testing Capabilities

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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