Contract manufacturing

Stemmatters addresses all manufacturing steps from material reception to the product’s fill and finish, batch release, storage and retrieval, under cGMP compliance. Our quality management system (QMS) ensures complete continuity in the chain of identity and custody, mitigating traceability risk and providing total transparency over our supply chain operations.

Our contract manufacturing services include

Isolation and banking of a wide range of human cells

Establishment of research-grade and/or clinical-grade MCBs and WCBs

Manufacturing of ATMPs, including SCTMPs and TEPs

Design of the cGMP manufacturing process and aseptic process validation strategy

Development of process documents such as MBRs, SOPs, and Forms

Aseptic fill-and-finish services for final product preparation

GMP-compliant storage at ambient, refrigerated, or cryogenic temperatures

QC testing and clinical batch release with full documentation

Access to an in-house Qualified Person (EU) for clinical batch release

Cell banking

Stemmatters develops and implements procedures for the isolation and banking of a wide variety of human cells. We produce well-characterised research- or clinical-grade MCBs and WCBs, stored in vials or bags under vapour-phase liquid nitrogen or in freezers. Our services ensure a sustainable supply of qualified starting material that meets quality specifications, validated through cell characterisation and functional assays.

Advanced therapies

Stemmatters specialises in the manufacturing of advanced therapy medicinal products (ATMPs), including somatic cell therapy medicinal products (SCTMPs) and tissue-engineered products (TEPs). These therapies are produced under validated standard operating procedures (SOPs) and adhere to the regulatory framework of (EC) No. 1394/2007, ensuring compliance and quality at every stage.

Blood-derived biologicals

Stemmatters has valuable experience in the manufacturing of biological products, including blood-derived biologics, exosomes and conditioned media. We have an excellent track record in manufacturing of complex blood-derived biologicals either as medicinal product or non-pharmaceutical/raw materials to support cell culture.

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