Viral Clearance Testing | Bioscience Labs

Viral Clearance

Viral Clearance

BioScience Laboratories Virology lab performs has Viral Clearance studies to provide safety data for biopharmaceutical products or medical devices that are derived from human or animal tissues. capabilitiesWe design Viral Clearance studies in compliance with the relevant guidelines and standards such as Q5A Viral Safety Evaluation, ISO 22442-3, The European Note for guidance on virus validation studies.  to verify and provide safety data for biopharmaceutical products or medical devices that are derived from human or animal cell lines[KB1] . This data is critical for companies who manufacture biopharmaceutical products or medical devices that utilize human or animal cell components to ensure the removal or inactivate viruses. Performing a Viral Clearance studyies is verify virus inactivation or removal  an important part ofand  any validate safety of manufacturersing processes and final products. to ensure product safety. BSLI performs viral clearance studies using utilizes the below viruses which include but are not limited to:

  • Herpes Simplex Virus (BDNDNA, enveloped)
  • Influenza A (RNA, enveloped)
  • HIV (RNA, enveloped)
  • Bovine Viral Diarrhea (RNA, enveloped)
  • Zika Virus (RNA, enveloped)
  • Poliovirus (RNA, non-enveloped)
  • Hepatitis A virus (RNA, non-enveloped)
  • Adenovirus (DNA, non-enveloped)

Viral strains to be used are specific to each individual study. Contact us today to speak to one of our experts and get your study design started.

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Virology Laboratory

BioScience Laboratories assists clients with new product development, R&D projects, marketing claims, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabilities with over 23 years of experience in conducting GLP and GCP compliant studies, we can offer a start-to-finish solution. Our personnel lead by Dr. Volha Teagle…

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ISO 22442-3

Medical devices utilizing animal tissues and their derivatives – Part 3:  Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (December 15, 2007).

BioScience Laboratories provides a scale down testing per ISO 22442-3 to meet ICH Guideline “Q5A Viral Safety Evaluation of Biotechnology Product Derived…

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