Biopharmaceutical Testing by Product Category | Charles River

manufactured products 

Current Good Manufacturing Practice (cGMP) testing is required for manufactured products in order to meet the compliance standards of the international regulatory authorities. Charles River Biopharmaceutical Services (BPS) offers a comprehensive range of tests for medicinal drugs and medical devices. Our global testing capabilities and extensive in-house experience enable us to design testing packages that specifically suit your needs, while following the relevant guidelines.

Medicinal Drug (Oral Solutions/Injectables/Nasal)

  • Finished product (cGMP)
  • Endotoxin testing
  • Excipient testing
  • General safety testing
  • Identity testing 
  • Preservative effiicacy
  • Physico-chemical characterization
  • Potency
  • Purity/impurity profiling
  • Pyrogenicity
  • Stability
  • Sterility
  • Toxicology


Medical Devices

  • Raw Materials
    • (Bioburden, cytotoxicity, in vitro endotoxin testing, microbial analysis of water, microbial limits, sterility)
    • Process validation
  • Finished Product
    • (Bioburden, in vitro endotoxin testing, microbial limits, sterility)
    • Process validation
  • Drug delivery
    • Injectables, drug-coated devices
    • Endotoxin, pyrogenicity, sterility


To check which of our BPS facilities perform these services, click here. For additional information, please contact us at askcharlesriver@crl.com or 1.877.CRIVER.1.

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For more information, contact us at:

1.877.CRIVER.1 (1.877.274.8371)
askcharlesriver@crl.com

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