Enabling Innovators.

Manufacturing Therapies.

Delivering Hope.

Your global partner for cell and gene therapy development, GMP manufacturing and advanced testing services.

Gene Edited Autologous Cell Therapies

Partnering with us enables you to accelerate your gene-edited autologous programs, including CAR-T and TCR-T programs, through proven process development, GMP manufacturing, and in-house testing, reducing vein-to-vein time and improving patient access.

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Gene Edited
Allogeneic Cell Therapies

Our global network supports scalable, off-the-shelf therapies including NK, HSC, and iPSC platforms. We support client-defined allogeneic processes with integrated analytics and regulatory expertise.

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Non – Edited
Allogeneic Cell Therapies

We provide end-to-end support for non-edited allogeneic therapies, combining robust platforms, global GMP facilities, and QC testing to enable reliable cell supply.

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Non – Edited Autologous
Cell Therapies

With more than 25 years of autologous expertise, Minaris Advanced Therapies ensures consistency, scalability, and faster turnaround for patient-specific therapies, from early-phase to commercial supply.

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Vaccines

Our extensive experience makes us a trusted partner for vaccine characterization and lot release, enabling us to accelerate programs from discovery through commercial supply.

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Viral Vector Gene Therapies

Our integrated viral vector services span plasmid design, process development, and GMP manufacturing for AAV and LVV platforms, supported by proprietary TESSA® and XOFLX™ technologies.

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mAbs &
Recombinant Proteins

Our three-tiered biosafety approach ensures regulatory compliance and accelerated release timelines, including characterization, purification process evaluation, and lot release. Our analytical team provides the full characterization, including potency, identity, and purity analysis.

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ABOUT MINARIS

With a robust track record of more than 25 years as a cell and gene therapy CDMO and over 40 years in analytical and biosafety testing, Minaris has produced 7,500+ GMP batches, currently manufactures two commercial therapies and tests more than 25 commercial products.

By the Numbers:

7,500+

GMP batches produced

60+

GMP clean rooms

600,000

f2 of infrastructure

22

patents in discovery services

25+

commercial products tested

40+

years of testing experience

4

commercial approved sites

1,700

developed assays

Capabilities

Comprehensive Cell & Gene Therapy Manufacturing Capabilities

End-to-End Cell Therapy Services

We offer a low-risk, seamless scale-up from Phase 1 to commercial production, with global quality systems that ensure regulatory compliance. Integrated biosafety testing and product characterization services expedite vein-to-vein turnaround times.

Biologics & CGT Testing

Minaris Advanced Testing

Standalone or integrated GMP testing across all biologics modalities, performed in our dedicated 140,000 ft² Philadelphia facility. With over 40 years of experience, we support cell therapies, viral vectors, monoclonal antibodies, recombinant proteins, and vaccines with rapid, regulator-accepted results.

Need standalone or integrated testing?

Explore Testing Services

  • Analytical Development

    Our analytical scientists design, optimize and validate assays across the full lifecycle, from early-phase methods to commercial readiness. Services include potency, purity, identity and stability testing, aligned with ICH Q2 and global regulatory expectations. Integrated with development and manufacturing, we ensure reliable GMP performance across all modalities.

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  • Assay Transfer

    Smooth assay transfer ensures continuity and reliability across sites and studies, maintaining consistency and accuracy. We deliver structured, data-driven transfers, including gap analysis, bridging studies and qualification/validation, in accordance with ICH Q2. Methods are supported across viral vectors, gene-edited cells, monoclonal antibodies (mAbs), proteins and vaccines, ensuring seamless readiness for lot release, stability and comparability studies.

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  • Biosafety Testing

    With more than 40 years of biosafety expertise, Minaris provides GMP-compliant sterility, mycoplasma, endotoxin, adventitious agent and replication-competent virus testing. Our specialized focus on CGT ensures risk-based strategies tailored to viral vectors, plasmids and packaging systems. Results are audit-ready and regulator-accepted, supporting IND, IMPD and BLA submissions worldwide.

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  • Cell Line Characterization

    We provide comprehensive, regulatory-compliant characterization of Master, Working and End-of-Production Cell Banks, including sterility, mycoplasma, endotoxin, retroviral and identity testing. Our services align with the guidelines of the ICH, FDA, EMA and PMDA, enabling the faster release of GMP cell banks and seamless integration into development and manufacturing workflows.

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  • Lot Release

    A reliable lot release ensures that therapies reach patients without delay. Minaris provides a comprehensive GMP testing panel across various modalities, including sterility, identity, potency, purity, residuals, RCL/rcAAV and more. With thousands of batches tested, our validated assays support global submissions and commercial approvals, minimizing risk and accelerating patient access.

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  • Potency

    Potency is a critical quality attribute. We design and validate custom assays, ranging from cell-based functional studies and reporter gene assays to ELISA, PCR and transduction efficiency tests. All assays meet ICH Q2 standards, providing meaningful biological insights that satisfy regulators and support product release and lifecycle management.

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  • Stability

    We deliver ICH Q1-compliant stability programs, including long-term, real-time, accelerated and ongoing studies. Our methods support all biologic and advanced therapy modalities, with submission-ready data for global regulators. By evaluating shelf life and storage conditions, we ensure that therapies maintain their safety, quality and efficacy throughout distribution and patient use.

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  • Viral Clearance

    A global leader with 3,000+ studies and zero regulatory rejections, Minaris designs viral clearance studies aligned with ICH Q5A(R2), FDA, EMA and WHO guidelines. Dedicated viral clearance suites with AKTA systems ensure rigorous validation across vectors, proteins and vaccines, safeguarding patient safety and accelerating regulatory approvals.

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State-of-the-Art Facilities

Global Network for
Manufacturing, Testing and R&D

Minaris operates five sites across the U.S., Europe and Asia, encompassing GMP manufacturing, advanced testing and R&D facilities.

    • Allendale, NJ : Commercially approved facility with 10 GMP suites specializing in CAR-T, MSC, HSC and iPSC programs.
    • Philadelphia, PA : Three facilities, including our 140,000 ft² dedicated testing facility.
    • Munich, Germany : Brand new state-of-the-art facility, 10+ years of experience on site.
    • London, UK : Discovery and R&D focused on viral vector and plasmid technologies
    • Yokohama, Japan : Licensed for regenerative medicine and equipped with advanced 3D bioreactor platforms.

QUALITY

Commitment to Quality & Innovation

At Minaris, quality is built into every step of development, manufacturing and testing. Our global Quality Management System (QMS) ensures consistency across sites, adapting to the program stage, from early-phase flexibility to commercial-scale rigor. Recent successful inspections by the FDA, EMA, PMDA, MFDS, TGA and USDA reflect our proven compliance record.

  • Proven Global Compliance

    Our facilities and processes meet international standards:

    • ISO/IEC 17025:2017 accreditation
    • FDA drug establishment registration
    • EMA, TGA and PMDA GMP certificates
    • USDA registration for applicable products

  • Quality First

    • Global QMS: Integrated systems harmonize SOPs, training, quality events and change control across all facilities.
    • Inspection Readiness & Audit Support: Hosting 100+ client and EU QP audits annually with full inspection-readiness planning.
    • Phase-Appropriate Quality Controls: Tailored to each development stage, balancing agility in early phases with compliance for late-phase licensure.
    • Change Control & Continuous Improvement: Strong frameworks to maintain quality, effectiveness and optimize processes.
    • Qualified Person (QP) Release: EU-based QP services enable compliant release of ATMPs into European markets.

Why Minaris?

Minaris unites global manufacturing and testing expertise to accelerate cell and gene therapies, lower costs and expand access to life-changing treatments for patients worldwide.

  • One Minaris

    A unified approach that eliminates tech transfer barriers and ensures seamless scaling.

  • Industry Leadership

    25+ years of experience in cell therapy manufacturing, supporting global biotech and pharma innovators.

  • Patient-Centric Approach

    We are committed to accelerating cures and expanding access to life-changing therapies.

Knowledge Center

Explore More Resources

Through our Knowledge Center, we share data-driven insights and best practices from across the industry to help you stay ahead of evolving expectations.

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Minaris Services

Contact Us

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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