GMP Manufacturing 

Minaris Regenerative Medicine has over 20 years of experience as a specialized cell and gene Contract Development and Manufacturing Organization (CDMO). We perform GMP manufacturing of all types of cell products and have a clear understanding that each project has unique characteristics and needs.

Regulatory Compliance

We offer you comprehensive manufacturing experience fully compliant with relevant regional regulatory requirements of our global facilities in the USA (FDA), Germany (EU-wide, EMA), and Japan (PMDA).


Learn more about how our experts can support your GMP manufacturing project starting from technology transfer to clinical manufacturing, and ultimately to commercial production of your ATMPs.


Technology Transfer

Minaris Regenerative Medicine has completed more than 100 successful technology transfers for cell therapy products. We take a systematic and strategic approach to transfer your technical knowledge/experience, specifications, procedures, and other critical data to our organization. If required, we offer in-house process development to adapt your process to GMP conditions or to further optimize the process

Our goal is to establish a GMP-compliant manufacturing process based on state-of-the-art technologies that is required for your respective clinical stage and that meets all regulatory requirements (FDA, EMA, or PMDA).

State-of-the-art technology services established for contract manufacturing 

  • Thawing (e.g. ThawStar, Plasmatherm)
  • Automated and closed washing/isolation (e.g. CliniMACS Plus, Sepax, Sefia) 
  • Genetic modification (e.g. viral, non-viral, electroporation)
  • Automated and closed cell manufacturing platform (e.g. CliniMACS Prodigy)
  • Culture of suspension and adherent cells (e.g. CellStack , culture bags, G-Rex)
  • Bioreactor systems (e.g. Xpansion, Xuri, Sartorius 50 L) 
  • Manual and semi-automated Fill and Finish (e.g. cryovials, cryobags)
  • Cryopreservation (e.g. Bio-Freeze, CryoMed)


Clinical Manufacturing

Minaris Regenerative Medicine listens to your specific needs, challenges, and goals, and creates a customized cell-based therapy clinical contract manufacturing program designed for a fruitful and valuable partnership.

We help you progress through the various stages of clinical development and optimize your manufacturing process towards commercial viability by providing an ideal environment. 

Our GMP manufacturing capabilities include:

  • Automated cell therapy manufacturing processes, including the Fill and Finish of the product. This allows us to create closed systems that enhance the efficiency and reliability of production and improve GMP compliance for the product.
  • Extensive experience with cGMP manufacturing for Phase III trials. We help you bring your product towards commercial manufacturing readiness by identifying issues potentially affecting the quality, scalability, sustainability, and cost of goods, and providing advice on how to overcome them.

Providing an optimal environment for clinical contract manufacturing

  • Pharmaceutical Quality System (PQS) in accordance with essential national and international regulations
  • Various control strategies to prevent microbial, endotoxin and particle contaminations
  • Matrix-based training system that can be tailored to the needs of the employees for GMP-compliant work
  • Supply chain with ERP system to guarantee availability of GMP-compliant materials
  • Confidential communication with local regulatory authorities during implementation of the manufacturing process
  • Smoke studies based on our in-house experience to ensure efficient air circulation and to eliminate detrimental impact on manufacturing processes 
  • EU: General and commercial ATMP manufacturing authorizations for fast transition towards production

Commercial Manufacturing

Flexible capacities to support commercial contract manufacturing:

  • Six state-of-the-art facilities with appropriate infrastructure on three different continents (North America, Europe, and Asia Pacific)
  • Cleanrooms of various classes (grade A to D)
  • In total >30 cleanrooms (grade B) 
  • Seamless transition to commercial production for late-stage products
  • Established multi-batch concept for parallel manufacturing in one cleanroom
  • Electronic hygiene monitoring system (MODA) for efficient control of the hygienic status of the cleanrooms
  • Electronic manufacturing execution system (MES) to streamline and accelerate commercialization
  • Long- and short-term cryostorage of starting materials, intermediates, and final products
  • Batch certification / release services by Qualified Person (QP) for products manufactured for the European market