GMP Certification | Cellcolabs

Q: What is Good Manufacturing Practice (GMP)?

Good Manufacturing Practice (GMP) is a pharmaceutical quality framework that defines how products must be produced, tested, and documented to ensure safety and consistent quality. It includes detailed requirements for facilities, equipment, personnel training, controlled processes, documentation, and traceability.

Q: Why is GMP important?

GMP ensures that products are manufactured to the same verified standard every time, minimizing risks such as contamination, mix-ups, and variability. For cell-based therapies, GMP helps secure consistent viability and quality across batches so clinical studies can generate reliable and comparable data.

GMP Certified. Built for scale.

Independently certified.

Certified by the Swedish Medical Products Agency, our Stockholm facility meets all requirements for producing mesenchymal stem cells (iATMPs).

Every batch is traceable.
Every step is documented. 
Every deviation is investigated.

What our certification covers:

Facility and cleanroom classification
Qualified personnel and documentation control
Validated equipment and aseptic processes
Traceability from donor → final product → clinical use

What our quality control includes:

Phenotyping confirms stem cell identity through defined surface markers (CD90, CD73, CD105).
Cell counting and viability testing ensure accurate dosing and functional activity.
Karyotyping verifies chromosomal integrity and genetic stability.
Sterility and endotoxin testing confirm aseptic conditions and exclude immune-reactive contamination.
Mycoplasma testing detects microbial contaminants that can affect cell behavior.
Environmental monitoring (EM) continuously verifies the quality of cleanroom air, surfaces, and equipment.

Before any batch is approved, a Qualified Person independently reviews all documentation, safety data, and test results to confirm full GMP compliance. Only then can the product be used in regulated clinical research.

Download GMP certificate ↗

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Frequently asked
questions

What is Good Manufacturing Practice (GMP)?

Good Manufacturing Practice (GMP) is the pharmaceutical framework that defines how products are produced, tested, and documented to ensure quality and safety. It sets detailed requirements for facility design, equipment, staff training, documentation, and testing — ensuring that every product is manufactured under controlled, traceable, and verifiable conditions.

Why is GMP important?

GMP ensures that every product is manufactured to the same verified standard of quality, no matter when or where it is produced. It minimizes risk by preventing contamination, mix-ups, and variability — maintaining strict control over safety, purity, and consistency.

For cell-based therapies, this ensures that every study receives cells of consistent viability, allowing clinical trials to generate accurate, comparable data.

How does a GMP facility differ from a standard research laboratory?

A GMP facility operates under pharmaceutical-grade controls. Every process is validated, every environment is monitored, and every material is traceable.
Unlike research laboratories, which are designed for exploration, GMP facilities are designed for precision and reproducibility — ensuring that results can be trusted, repeated, and reviewed by regulatory authorities.

Potent and consistent

Cryopreserved at Passage 3 for optimal cellular capacities and potency.

Defined cell identity

Phenotyping confirms MSC markers (CD90, CD73, CD105), ensuring purity.

Genetically stable

Karyotyping verifies chromosomal integrity across passages.

Antibiotic-free and sterile

All batches undergo bacterial and mycoplasma testing.