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Cell Therapy Process & Analytical Development

A Smarter Path to Scalable Cell Therapy Manufacturing

Minaris Advanced Therapies brings decades of hands-on experience in developing and scaling cell therapy processes for both autologous and allogeneic platforms. Our team has developed processes that have successfully scaled multiple therapies to commercial levels. Our manufacturing team’s expertise in the field includes over 7,500 GMP batches produced.

Our analytical development teams have developed analytical test methods that are fit for purpose, scientifically sound, and ready for release or support clinical processes as in-process control (IPC). These methods address the health authority requirements in describing the final products’ Safety, Identity, Strength, Quality, and Purity.

Whether you’re advancing an autologous therapy or optimizing an allogeneic workflow for global scale-up, Minaris offers technical insight, regulatory familiarity and integrated infrastructure to accelerate your development with confidence.

An Integrated Approach,
From Concept to Clinic

Our cell therapy PD and AD services are fully integrated with upstream and downstream functions across our global network, enabling seamless knowledge transfer, reduced risk and speed from development to GMP.

We support:

  • Autologous and allogeneic cell therapies
  • Viral and non-viral gene-edited products
  • T cell (CAR-T, TCR-T, TIL, and Treg), NK cell, stem cell (HSC, MSC and IPSC), and combination products
  • Closed and semi-closed systems, specific cell type isolation, electroporation, transduction, expansion, formulation and fill and cryopreservation workflows
  • Cell expansion with suspension culture (Xuri, Prodigy, G-Rex, etc.) or adhesion culture (Cell factories, 3D bioreactors, hyperstacks, flasks, etc.).

Minaris offers clinical phase-appropriate development based on our extensive expertise, with the required regulations in mind for the US, EU and Japan and dedicated labs for process and analytical development.

Learn About Our Cell Therapy Service

Empowering Through Expertise and Innovation

For genetically modified cell therapies, high-performing constructs are essential for reproducible electroporation, transduction, or stable integration. We design and develop vectors, plasmids and other delivery formats used in:

 

  • CAR-T and TCR-T engineering

  • CRISPR-based gene editing

  • Non-viral integration systems and transposons

Our scientists draw from experience with hundreds of cell therapy programs to bring best practices, platform learnings and regulatory intelligence into every project.

We provide:

Early-phase tech transfer and protocol onboarding

Protocol development from scratch for early-stage clients

Process development for more closed and automated workflows

Optimization of media formulation, activation, gene editing, transduction, expansion, harvesting, final formulation, filling and cryopreservation steps

Assay development and integrated biosafety and product characterization testing

Evaluation of critical process parameters (CPPs) and critical quality attributes (CQAs)

Scale-up strategies from research to clinical to commercial production

By applying proven approaches from commercial programs, we accelerate process development cycles, enhance quality control and build a strong foundation for long-term manufacturing success.

Tools and Technologies That Challenge the Status Quo

We integrate forward-thinking technology solutions into every development program, helping clients reduce cost of goods, increase consistency and prepare for industrialization.

  • Fast-tracking tech transfer to reduce project timeline
  • Cost-effective process design to reduce process time and cost
  • Closed system and single-use technologies to reduce contamination risk and enhance reproducibility
  • Automated fill and finish systems to support commercial readiness
  • Real-time analytics and in-process controls to enable proactive decision-making
  • Proprietary lentiviral and AAV production systems (XOFLX™, TESSA®) for streamlined vector supply

Global Process Development, Locally Executed

Our PD and AD labs and GMP manufacturing facilities are co-located across North America, Europe and Asia, enabling seamless tech transfer and region-specific regulatory alignment. Each site follows a harmonized quality system to ensure consistency, no matter where development occurs.

Facilities include:

  • Dedicated PD and AD labs in Germany (Munich), the US (Philadelphia, PA and Allendale, NJ) and Japan (Yokohama)
  • Integrated analytics and assay development teams
  • GMP manufacturing in all three regions, minimizing revalidation timelines

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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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