Viral Clearance

Nelson Labs' Virology lab performs Viral Clearance studies to provide safety data for biopharmaceutical products or medical devices that are derived from human or animal tissues. We design Viral Clearance studies in compliance with the relevant guidelines and standards such as Q5A Viral Safety Evaluation, ISO 22442-3, and 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. These data are critical for companies who manufacture biopharmaceutical products or medical devices that utilize human or animal cell components to ensure the removal or inactivation of viruses. Viral Clearance studies verify virus inactivation or removal and validate safety of manufacturing processes and final products. BSLI utilizes the following viruses which include but are not limited to:

• Herpes Simplex Virus (DNA, 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.

ISO Standards

ISO standards are a set of guidelines that ensure quality, safety and efficiency for you products. This is not a complete list of BSLI’s capabilities, connect with our experts...

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 encephalopat...

Virology Testing Laboratory

BioScience Laboratories can assist with new product development, R&D projects, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabili...