Development and manufacture of chemically defined, xeno-free cell culture media for 2D and 3D cell culture
CELLnTEC Advanced Cell Systems
Bern, SwitzerlandNew on Amplifa
About CELLnTEC
CELLnTEC Advanced Cell Systems is a developer and manufacturer of chemically defined, xeno-free and serum-free cell culture systems based in Bern. The company produces precision media for human primary cells, stem cells, iPSCs and advanced in-vitro 3D models, including formulations for epithelial cells, fibroblasts, melanocytes, endothelial cells and co-cultures. The products contain no components of animal or human origin and support reproducible, standardized 2D and 3D cell culture systems, including 3D airlift culture. Production is carried out according to Standard Operating Procedures with documented workflows from raw material receipt through manufacturing to packaging and release; every batch is tested against defined specifications. Higher Certified (HC) products with extended testing accompany the transition from research to Phase I–III clinical trials. Customers are biotech and pharmaceutical companies as well as academic research laboratories worldwide; media production scales from small to large liquid volumes, from bottles to bags.
- Site
- Bern
- Processes
- Development and manufacture of chemically defined, xeno-free and serum-free cell culture media, Manufacture of Higher Certified (HC) media for the transition from laboratory to clinical trials, Scaling of cell culture media from small to large liquid volumes, from bottles to bags, 3D airlift culture (differentiation of epithelial cells), Technical support by the R&D team (support@cellntec.com), Order and logistics support (orders@cellntec.com), Scalable media production from small to large liquid volumes, from bottles to bags, Process development and biological expertise for scale-up
- Materials
- Chemically defined media, Xeno-free and serum-free media, Higher Certified (HC) products, 3D airlift culture
- Certificates
- QMS based on ISO-9001 principles, Batch testing according to defined specifications, Qualification and calibration of critical equipment, Extended testing for HC products
- Industries
- Biotechnology, Pharma, Regenerative Medicine / Cell Therapy (ATMP), Academic Research, Preclinical Research / New Approach Methods (NAMs)
- 01
Media development
- 02
Raw material qualification and goods receipt
- 03
Manufacturing according to SOP
- 04
Batch testing according to defined specifications
- 05
Packaging and release
- 06
Worldwide distribution and technical support
Media Formulations and Culture Systems
Chemically defined media
Fully defined formulations free of components of animal or human origin for reproducible 2D and 3D culture.
Xeno-free and serum-free media
Formulations free of xeno-components for human-relevant, regulatory-compliant cell culture systems.
Higher Certified (HC) products
Media with extended testing for use in regulated environments and Phase I–III clinical trials.
3D airlift culture
Media for the differentiation of primary human epidermal keratinocytes and other epithelial tissues in 3D airlift culture.
Locations
Bern
CHHeadquarters, development and production
- Materials
- Chemically defined, xeno-free and serum-free cell culture media
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development and manufacture of chemically defined, xeno-free and serum-free cell culture mediaEngineering | – | – | – | – | – |
| Manufacture of Higher Certified (HC) media for the transition from laboratory to clinical trialsEngineering | – | – | – | – | – |
| Scaling of cell culture media from small to large liquid volumes, from bottles to bagsEngineering | – | – | – | – | – |
| 3D airlift culture (differentiation of epithelial cells)Engineering | – | – | – | – | – |
Additional services
Quality
CELLnTEC operates a comprehensive quality management system based on the core principles of ISO 9001. Every product batch is tested according to defined specifications; the performance of the media is evaluated in relevant cell culture assays.
| Evidence | Bern |
|---|---|
| QMS based on ISO-9001 principles | |
| Batch testing according to defined specifications | |
| Qualification and calibration of critical equipment | |
| Extended testing for HC products |
History
Founded with the vision of replacing animal experiments with human-relevant in-vitro systems; the 3R principles (Replace, Reduce, Refine) are part of the founding vision.
More than two decades of scientific experience: publications, preclinical programs and clinical trials (Phase I–III) are supported with the products.
Launch of the new website to improve access to cell culture solutions, technical resources and application support.