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service

Contract manufacturing

Stemmatters can assure all manufacturing steps from material reception through to fill, finish, storage and retrieval...

Cell Therapy

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).

Stemmatters can assure all manufacturing steps from material reception through to 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. We operate with a range of cell types, including dendritic cells, T-cells, natural killer (NK) cells, pluripotent stem cells, mesenchymal stromal cells (MSCs) and more.

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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.

Biopharmaceuticals

Stemmatters is very well acquainted with the production of biological 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. Stemmatters provides manufacturing and supply services for biological products, and can assist in sourcing of starting materials.

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Quality Control

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

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We understand the importance of developing and operating a full framework of QA / QC practices and procedures. We have experience with a broad range of batch release assays, including:

  • Endotoxin quantification - LAL test
  • Mycoplasma by qPCR
  • Sterility assessment
  • Immunoquantification of cell metabolites
  • Cell viability and morphology evaluation
  • Cell performance evaluation (such as cell metabolic activity, cell growth, cell phenotypic characterization, gene-expression, among others)
  • Integrity filter testing
     

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

Cell Banking

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) and working cell banks (WCB). Establishing a cell bank ensures a ready and sustainable supply of starting material that is fully qualified according to quality specification.

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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.

Aseptic Filling & Storage

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

Stemmatters develops solutions to meet challenges and requirements of aseptic fill & finish of biopharmaceuticals and ATMPs.

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Stemmatters offers 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.