Stem cell and advanced cell / gene therapy requires ultra-controlled cleanroom environments that ensure sterility, product integrity, and regulatory compliance. Whether you produce autologous or allogeneic therapies, iPSC lines, primary cells, viral vectors, or regenerative medicine products, MRC Cleanroom Systems delivers GMP-compliant, aseptic cleanroom solutions engineered for the unique demands of cell-based manufacturing.

​

Our Services for the Stem Cell & Cell Therapy Industry

MRC provides a fully integrated cleanroom solution, including:

​

• Cleanroom design & consultancy

• Turnkey construction

• HVAC & MEP engineering

• MRC GRP and MRC HPL modular cleanroom panels

• Doors, vision panels, pass-boxes and accessories

• Validation support (IQ/OQ/PQ)

​

Our GRP and HPL panels deliver seamless, hygienic, non-porous surfaces ideal for aseptic environments, with long-term resistance to cleaning agents, disinfectants, and bio-decontamination processes including H₂O₂.

​

Regulatory & Specification Considerations

We design and build stem cell and advanced therapy cleanrooms fully aligned with:

​

• EU GMP Annex 1 – Aseptic manufacturing requirements

• EU GMP Part IV / ATMP Guidelines

• FDA cGMP – 21 CFR Parts 210/211 & Part 1271 (HCT/Ps)

• ISO 14644-1 / ISO 14644-2 – Cleanroom classification & monitoring

• ISO 20399 – Laboratory equipment and workflows for cell processing

• Requirements for Grade A/B aseptic zones and segregated processing

• Environmental monitoring integration for viable and non-viable contamination

• Material & personnel flows designed to prevent cross-contamination

​

We incorporate industry-specific needs such as segregated suites, closed vs. open processing layouts, cryogenic storage integration, vector-handling zones, and cleanroom designs that support clinical and commercial-scale cell processing.

​

​

Why Choose MRC for Stem Cell & ATMP Facilities?

• Deep experience delivering GMP facilities for biotech and cell therapy

• Seamless GRP panel systems ideal for aseptic and cleanable environments

• Proven designs for Grade A/B/C/D cleanrooms and BSL-2/BSL-3 areas

• Walk-on ceilings and robust structures for heavy equipment access

• Long lifespan, low particulate shedding, and minimal maintenance requirements

​

​

Build Your Next Cell Therapy and ATMP Cleanroom

Speak to our team for early design development, facility retrofitting, modular expansions, or complete turnkey cell therapy cleanroom projects.