VACCINE TESTS (INACTIVATED) EP 0153 AND USP 1235

SGS, a leading Life Science bio/pharmaceutical, analytical and bioanalytical contract organization, offers its expertise on GMP analyses. Our tests are made according to Pharmacopeia : EP, JP, USP or based on analytical methods validated according to ICH guidelines.

LIFE INSPIRED, QUALITY DRIVEN

LIFE SCIENCES

VACCINES FOR HUMAN USE

EXPERTISE

SGS LIFE SCIENCESSGS Life Sciences enables themedical and health innovators to deliver life-changing solutions in the quickest, safest and most effi cient way, helping improve the lives of many. We provide the highest quality services, reliable expertise and guidance through our network of laboratories conveniently located around the globe.

MICROBIOLOGICAL TESTS

• Sterility (EP 2.6.1 / USP 71)

• Particulate contamination (EP 2.9.19 / USP 788)

• Bacterial endotoxins (EP 2.6.14 / USP 85)

CHEMICAL TESTS

• pH (EP 2.2.3 / USP 791)

• Adjuvants : aluminium (EP 2.5.13) and Calcium (EP 2.5.14)

• Formaldehyde (EP 2.4.18)

• Phenol (EP 2.5.15) and antimicrobial agents (USP 341)

• Water content (EP 2.5.12 / 2.5.32 / USP 921)

• Loss on drying (EP 2.2.32 / USP 731)

• Extractable volume (EP 2.9.17)

• Deliverable volume (USP 698)

• Glass containers for pharmaceutical use (EP 3.2.1 / USP 660)

• Rubber closures (EP 3.2.9 / USP 381)

ADDITIONAL TESTS AVAILABLE THROUGH THE SGS NETWORK

• Molecular weight

• Peptide mapping

• RMN or DSC (circular dichroïsm)

• Viral testing / Biosafety

• Extractables and Leachables « E&L »studies

• Stability Studies (according to ICH guidelines)

WE’RE ALSO ABLE TO PERFORM TESTING ON STABILIZERS ACCORDING TO USP CHAPTER LIKE :

• Amino acids

• Sugars

• Triton like residues

• Antibiotic residues

• Content by SEC (size exclusion chromatography)

SGS is a leading Life Science bio/pharmaceutical, analytical and bioanalytical contract organization providing biologics characterization, biosafety, and quality control testing to large pharmaceutical and biotechnology firms. Through their network of laboratories conveniently located in North America, Europe, and Asia-Pacific, SGS offers GMP/GLP compliant contract laboratory services including analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis.

CONTACT SGS LIFE SCIENCES

sgsgroup.fr/fr-fr/life-sciences

@SGSFrance

www.sgs.com/Linkedin-Life

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