Development and manufacture of in-vitro diagnostics for blood group serology, microbiology and immunoassays, as well as contract manufacturing of monoclonal antibodies.
sifin diagnostics gmbh
Berliner Allee 317–321, 13088 BerlinNew on Amplifa
About sifin diagnostics
sifin diagnostics gmbh is a family-owned diagnostics company based in Berlin. It emerged from the diagnostics division (microbiology, blood group serology) of the former State Institute for Immunological Preparations and Culture Media of the GDR; an investment by a German entrepreneurial family in 1992 secured its continued existence. The company develops, manufactures and distributes in-vitro diagnostics for human and veterinary applications, including blood group serological diagnostics, bacteriological test reagents (including for Salmonella, Shigella, Yersinia, E. coli), culture media in dehydrated and ready-to-use form, supplements and detection reagents, as well as immunoassays. A further area is the production and purification of monoclonal antibodies, which is also offered as contract manufacturing in concentrate, bulk or ready-to-use reagent format; in addition, an assay platform for agglutination tests. The portfolio comprises more than 600 standard products. As a distribution partner, sifin also offers the TECHLAB product line (rapid tests and ELISA) for gastrointestinal diagnostics. Export activities have been intensified in the target markets of Europe and Asia; the company operates worldwide. Around 90 employees work at the single site in Berlin.
- Site
- Berlin
- Processes
- Contract manufacturing of monoclonal antibodies (production and purification), Contract manufacturing of antibodies, Contract manufacturing of ready-to-use culture media, Contract manufacturing of bacteriological test reagents, Contract manufacturing of blood group serological products, Assay platform for agglutination tests, Contract manufacturing of monoclonal antibodies (concentrate/bulk/ready-to-use reagent), Distribution of TECHLAB product line (rapid tests and ELISA)
- Materials
- Monoclonal Antibodies, Culture Media, Bacteriological Test Reagents, Blood Group Serological Diagnostics, Immunoassays, GLY Virus Transport Medium
- Certificates
- DIN EN ISO 9001:2015, DIN EN ISO 13485:2021, DIN EN ISO/IEC 17025, ZNU Standard for Sustainable Business, ISO 9001, ISO 13485, ISO/IEC 17025
- Employees
- ca. 90
- Industries
- In-vitro Diagnostics, Medical Technology, Human and Veterinary Medicine, Microbiology, Blood Group Serology, Food Microbiology
- 01
Development of diagnostics
- 02
Cell culture-based production of monoclonal antibodies
- 03
Purification
- 04
Manufacture of test reagents and culture media
- 05
Filling/packaging
- 06
Distribution (own sales organization and export partners)
Product Areas and Processes
Monoclonal Antibodies
Production and purification as concentrate, bulk or ready-to-use reagent, also as contract manufacturing.
Culture Media
Dehydrated culture media, supplements, base materials, additives and ready-to-use culture media.
Bacteriological Test Reagents
Diagnostics for serotyping of Salmonella, Shigella, Yersinia and E. coli.
Blood Group Serological Diagnostics
Reagents for the determination of blood group antigens, bedside cards and automated system kits.
Immunoassays
Detection systems, including rabies virus detection.
GLY Virus Transport Medium
Ready-to-use glucose-lactalbumin-yeast transport medium for virus-containing samples, suitable for PCR.
Locations
Berlin
DEDevelopment, manufacture and distribution of IVD products; production and purification of monoclonal antibodies
- Materials
- Blood group serology, bacteriological test reagents, culture media, monoclonal antibodies
Products and Services
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Contract manufacturing of monoclonal antibodies (production and purification)Engineering | – | – | – | – | – |
| Contract manufacturing of antibodiesEngineering | – | – | – | – | – |
| Contract manufacturing of ready-to-use culture mediaEngineering | – | – | – | – | – |
| Contract manufacturing of bacteriological test reagentsEngineering | – | – | – | – | – |
| Contract manufacturing of blood group serological productsEngineering | – | – | – | – | – |
| Assay platform for agglutination testsTesting | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
The quality management system is certified to DIN EN ISO 9001:2015 and DIN EN ISO 13485:2021; a certificate according to DIN EN ISO/IEC 17025 is also listed in the product list.
| Evidence | Berlin |
|---|---|
| ISO 9001 | |
| ISO 13485 | |
| ISO/IEC 17025 | |
| ZNU Standard for Sustainable Business |
History
- 1992
An investment by a German entrepreneurial family secured the survival of the diagnostics division (microbiology, blood group serology) of the former State Institute for Immunological Preparations and Culture Media of the GDR; formation of sifin diagnostics gmbh.
- 2024
First systematic recording of sustainability activities; certification according to the ZNU Standard “Sustainable Business” in December 2024.
- 2025
Plastic reduction of 19% (overall) and digitalization of further processes.