SGS Cephac, The French Bioanalytical Unit Of SGS Life Science Services
Has been Reconducted in its GLP Certification
SGS is proud to confirm that its services continue to be provided in a GLP environment. Both the French site (Poitiers) and the Belgian site (Wavre) have been successfully audited by the respective national monitoring authorities, and both have been recertified.
Please consult the web site attached GLP certificates.
Has Invested in Flow Cytometry
In response to the increasing number of therapeutic antibodies and recombinant proteins entering the development phase, there is a greater need to assess potential immunogenicity. Over the past few years, SGS has invested in this area to come up with a bioanalytical service offering that is more complete than ever.
SGS now offers the highly versatile technology of Flow Cytometry to support clinical development. We currently operate a BD FACSCanto II (3 lasers - 8 colors) equipped with a High Throughput Sampler.
SGS Life Science Services is a global CRO with the expertise to develop assays from scratch and to support large scale routine sample analyses, from pre-clinical (pK IND toxicology submission packages) and clinical studies.
The following are examples of our immunoanalysis services:
- Immunogenicity screening assays (peptide drugs and therapeutic monoclonal antibodies)
- Detect levels of anti-drug antibodies present in subjects, including neutralizing antibodies
- Eliminate false negatives by selecting the appropriate cut-off point
- Discriminate between pre-existing and treatment-induced antibodies
- Development of appropriate cell-based assays for neutralizing antibodies
- Drug-antibody interference
- Quantification of therapeutic proteinsor antibodies to support Pre-clinical pharmacokinetic/toxicokinetic studies
- Clinical studies across all phases
Mark Di Diioia
SGS Life Science Services
90 av des Hauts de la Chaume
86281 Poitiers- France.
t: +33 (0) 5 49 57 50 35
f: +33 (0) 5 49 57 22 39
The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.