Viral Clearance Studies

Virus

Viral clearance is critical in the development of monoclonal antibodies, recombinant proteins and glycoproteins, tissue and blood-derived products and medical devices. Viral contamination usually comes from the use of cell lines, tissue sources or raw materials of animal origin. The ICH Q5A Regulatory Guidelines recommend that biopharmaceutical products for human use should ensure that their products' safety is not affected by potential contaminants.

Creative Biolabs offers a comprehensive, fully cGMP-compliant virus clearance service that spans all stages of the development, manufacture and release of biological products. Our virus clearance team has conducted thousands of tests for biopharmaceutical customers, all of which have been fully validated and followed ICH Q2 requirements.

Process Steps for Virus Clearance

Virus Inactivation

  • Organic Solvent
  • Detergent
  • Caprylate
  • Chaotropes
  • Low pH
  • High pH
  • Enzymes
  • Dry Heat
  • Pasteurization
  • Vapor Heating
  • High Temperature Short Time
  • Photo Inactivation
  • UV with Photoactive Compounds
  • Gamma Irradiation
  • Microwave

Virus Removal

  • Chromatography
  • Affinity
  • Ion Exchange
  • Hydrophobic
  • Gel Filtration
  • Nanofiltration

We offer virus clearance services for a variety of viruses to help you submit regulatory requests, including:

  • Adenovirus clearance
  • Retroviral clearance
  • Parvovirus clearance
  • Pseudorabies virus clearance
  • Influenza virus clearance
  • More…

Examples of products for virus clearance studies:

  • Monoclonal antibodies
  • Recombinant proteins
  • Blood-derived products
  • Gene therapy vectors
  • Viral vaccines Tissues
  • Urine-derived products
  • Tissue-derived products
  • Medical devices (including collagen-derived products)
  • Enzymes

With years of experience and a GMP-qualified laboratory, Creative Biolabs’ viral clearance services ensure that your biological production process complies with international guidelines.

For more details, please feel free to contact us for project quotations and more minute information.

For lab research only, cannot be used for any clinical use.

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