Stemmatters provides manufacturing of cell-based advanced therapy medicinal products (ATMPs), whether somatic cell therapy medicinal product (SCTMP), tissue engineered product (TEP), or gene-modified medicinal product (GMTP).

We can assure all manufacturing steps from material reception to final product’s fill & finish, storage and retrieval. Our integrated QMS ensures complete continuity in the chain of identity and custody, mitigating traceability risk and providing total transparency over our supply chain operations.

ATMPs are provided according to validated standard operating procedures (SOPs), compliant with regulation (EC) No. 1394/2007. Manufacturing at Stemmatters is provided under full cGMP compliance.

Stemmatters is experienced with the production of biological cell- and blood-derived products across all segments of the supply chain, including sourcing and processing of starting materials.

We have experience with isolating blood-derived compounds and producing cell-derived biologics. We provide manufacturing and supply services for biological products and can assist in sourcing of starting materials.

Quality assurance and control is central to patient safety, product performance, regulatory compliance and, ultimately, commercial success.

We understand the importance of developing and operating a full framework of QA / QC practices and procedures and we have experience with a broad range of batch release assays, including but not limited to:

• Endotoxin quantification - LAL test
• Mycoplasma by qPCR
• Sterility assessment
• ELISA/Multiplex for cytokines and growth factor quantification 
• Cell viability and morphology evaluation
• Cell performance evaluation (cell metabolic activity, cell growth, cell phenotypic characterization, gene-expression, among others)

Besides respecting our in-house quality practices, we work closely with our partners to ensure that their own quality programs are robustly implemented into our manufacturing service practices.

Cell banking provides integrity of a cell population and assures that cells are readily available for subsequent application.

Stemmatters offers services to develop and implement procedures for isolation and banking of a large variety of human cells, and to establish and maintain master cell banks (MCB) as well as working cell banks (WCB). Establishing a cell bank ensures a ready and sustainable supply of starting material that is fully qualified according to pre-defined quality specifications.

Storage can be performed in vials and/or bags, in vapour phase liquid nitrogen or in freezers. Cell characterisation and functional assays can be deployed to validate shelf life and storage properties of materials and cells.

Maintaining aseptic conditions through to the final finished product and container closure is critical to protecting product quality.

Stemmatters has several solutions to deliver aseptic fill & finish of biopharmaceuticals and ATMPs. We work with container sizes up to 50 L and can semi-automate sterile fill & finish operations up to 50 mL. Where our solutions are not optimal for your process, we can develop novel solutions bespoke to your needs.

We offer a full range of cost-effective services to develop, implement and validate process-end aseptic fill & finish procedures suitable for your product across a range of technology domains, in compliance with cGMP requirements.