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E. coli vaccine development support 

SSI Diagnostica Group’s involvement in vaccine development began over 40 years ago—then as Statens Serum Institut—by supplying antisera for quality control to a global vaccine manufacturer during the development of a pneumococcal vaccine. Today, SSI Diagnostica Group continues to provide leading vaccine developers as GSK, with high-quality products and scientific expertise across multiple disease areas including Escherichia coli

Overview: Current context for E. coli vaccines 

There are currently no widely licensed human vaccines against Escherichia coli for general use. The global burden of E. coli related disease — including diarrheal illness from enterotoxigenic E. coli (ETEC) and invasive infections from extraintestinal pathogenic E. coli (ExPEC)—highlights the ongoing need for effective vaccines. Active development focuses on ETEC and ExPEC; several ETEC candidates (e.g., ETVAX; CssBA with dmLT) are in clinical evaluation1 2 3.  

Our portfolio is structured to meet the evolving needs of vaccine developers from research & development all the way to post-market surveillance. 

 
Research and
development 

Pre-clinical 

Clinical 
studies

Production 

Post market
surveillance 
E. coli strains 
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E. coli antisera  
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High titer antisera*

Customization and contract manufacturing services

*The following antisera are available as high titer antisera off-the-shelf: O1, O2, O4, O6, O15, O16, O18ac, O25, O75. The other antisera can be produced as high titer on request. Please reach out for further information.

Please note: 
Product availability may vary by country. Some products listed in the table might not be registered or available in all markets. For detailed information on distribution and registration status in your region, please contact SSI Diagnostica Group or your local representative.

Research & development 

  • Supporting serotype identification and discovery 
  • Supporting with consistent QC design 
  • Providing raw materials (reference strains)  

Preclinical trials 

  • Raw material and support for in-house assays 

Clinical trials 

  • IVD tests for pre-screening of study participants 
  • Raw material and support for in-house assays 

Production 

  • Scalable supply of validated reagents 

Post market surveillance 

Ongoing support for surveillance and refinement 

Customization and contract manufacturing services  

  • Available across all development stages
  • Trusted by leading vaccine manufacturers for 40+ years 
  • High quality IVD products (IVDD / IVDR) 
  • Stable supply by 100% in-house production
  • Global distribution (130+ countries)
  • Compliant with manufacturing, regulatory and environmental standards / requirements (ISO 13485, ISO 14001, 21 CFR 820) 

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    References

    References

    1. Salvador-Erro, J.; Pastor, Y.; Gamazo, C. Targeting Enterotoxins: Advancing Vaccine Development for Enterotoxigenic Escherichia coli ETEC. Toxins 2025, 17, 71. https://doi.org/10.3390/toxins17020071 ↩︎
    2. IDCRC (NIAID). Trial evaluating ETEC vaccine (CssBA + dmLT) — March 12, 2025: https://idcrc.org/about/news-archive/etec.html ↩︎
    3. Johnson & Johnson Statement on Phase 3 E.mbrace Study (ExPEC9V) — February 13, 2025: https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-phase-3-e-mbrace-study ↩︎