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Global Footprint for Local Manufacture

Worldwide Network, Unified Quality

Minaris Advanced Therapies operates one of the broadest infrastructures in the industry with sites across the United States, Europe and Asia. Our global network includes more than 60 GMP clean rooms and 650,000 square feet of facilities. With over 7,500 GMP batches manufactured and more than 1,700 assays developed, we provide capacity, consistency and regulatory confidence at every stage.

Our harmonized SOPs and centralized quality systems ensure local manufacturing that meets global standards. This model delivers faster timelines, reduced risk and broader patient access.

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Global Facilities

United States

Europe

Asia

Philadelphia, Pennsylvania

Philadelphia, Pennsylvania

Description

Facilities

Highlights

The Philadelphia campus is the largest advanced therapies site in the Navy Yard, with three major facilities dedicated to manufacturing and testing.

  • 4701 League Island Blvd: 150,000 square feet for early, late phase and commercial cell therapy and viral vector production
  • 4000 S 26th Street: 55,000 square feet for late phase and commercial autologous and allogeneic non-viral manufacturing
  • 400 Rouse Blvd : 140,000 square foot dedicated testing facility, expanding testing capacity by 136 percent across virology, microbiology and QC.  This is also our corporate headquarters.
  • 16 cell therapy suites across two facilities
  • 8 viral vector suites up to 2000L
  • 12 process development labs
  • Dedicated GMP testing and analytical development laboratories
  • Three facilities with commercial approvals
  • EU approval of two sites
Allendale,
New Jersey

Allendale,
New Jersey

Description

Highlights

Founded as Progenitor Cell Therapy in 1999, the Allendale site boasts over 25 years of experience in cell and gene therapy manufacturing. In 2024, the site received FDA approval for commercial production and completed its first commercial run.

  • 10 Grade B clean rooms
  • 2 process development labs
  • Analytical and microbiology labs
  • Approved for commercial production
Munich,
Germany

Munich,
Germany

Description

Highlights

The Munich site has been GMP certified since 2011, with two commercialized cell and gene therapy products and ten manufacturing licenses. Its new Taufkirchen facility is designed for flexibility, with unidirectional flows and integrated cryopreservation.

  • 6 Grade B clean rooms
  • Process and analytical development
  • Clinical and commercial manufacturing
  • Donor material procurement and global logistics
  • In-house QP services and regulatory support
Yokohama,
Japan

Yokohama,
Japan

Description

Highlights

Licensed for regenerative medicine manufacturing since 2021, the Yokohama site offers comprehensive GMP/GCTP capabilities, with a particular strength in commercial supply. The site supports end-to-end development by integrating process and analytical development with both clinical and commercial manufacturing. It continues to advance CAR T, MSC, and iPSC projects, ensuring a seamless path from early development through large-scale production.

  • 6 Grade B clean rooms
  • 3 process development and analytical development labs
  • 6 quality control labs for microbiology and bioassay testing

Harmonized Global
Quality Systems

Our GMP batch releases are supported by unified quality systems that simplify regulatory submissions and guarantee consistent performance across all facilities. Minaris has successfully passed more than 20 inspections from global health authorities, including the FDA, EMA, PMDA, TGA, and MFDS. With over 100 client and EU QP audits each year, we provide regulatory assurance along with operational excellence.

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Seamless Tech Transfer Across Regions

Minaris facilitates fast and reliable technology transfer between sites, accelerating typical timelines. Our standardized processes reduce risks in late-phase and commercial transitions, while our dual sourcing capabilities support global launches and market growth. Whether you need local access for vein-to-vein autologous therapies or scalable manufacturing for allogeneic platforms, our network offers flexibility and resilience.

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Local Manufacturing, Global Impact

By combining global capacity with local execution, Minaris guarantees therapies reach patients more quickly, efficiently, and with uncompromising quality. Our integrated supply chain, in-house biosafety testing, and regulatory expertise make us a trusted CDMO partner for biotechs and pharmaceutical innovators worldwide.

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Minaris Services

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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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