GMP-Creative Biolabs provides one-stop customer-oriented services including biopharmaceutical contract R&D, process development, cGMP manufacturing, QA & QC solutions for scientific research, preclinical, clinical and commercial supply. We proceed your projects according to your specific demands in quality, timeline and budget, supporting researchers across different therapeutic areas. Clear, open and regular communication with customers is as important to our success as our in-depth scientific knowledge. more
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Creative Biolabs provides fully cGMP-compliant Viral Clearance Services with a wide selection of viral removal or viral inactivation processes, which is indispensable to demonstrate the safety of your cGMP manufacturing /cleaning processes. For each project, Creative Biolabs assembles a strong team of Ph.D. scientists with more than 20 years of experience, to optimize the design and performance of viral clearance processes using a customized approach and deliver the most suitable viral clearance service according to your budget, timeline, and specific requirements.
Service features
• Design of viral clearance studies (TSE clearance studies are also available)
• Establishment and verification of the process for viral clearance
• Multiple solutions to viral clearance
• Fully qualified facilities and instrumentation
• International regulatory support
Viral clearance testing is mandatory for investigational new drug (IND) submission and is a critical part of the biologic manufacturing process. Creative Biolabs provides viral clearance service compatible with ICH Q5A and other European, US and WHO regulatory guidelines.
Our viral clearance service on a diverse array of cGMP biopharmaceutical products including:
Methods of Viral Clearance Process
Viral Removal:
• Ethanol Precipitation
• Multiple Chromatography Systems
• Virus Removal Filtration
Viral Inactivation:
• Low or High pH
• Solvent/Detergent
• Chemical Treatment
• UV Treatment
• High Temperature Short Time(HTST) Treatment
• Pasteurization
To discuss your Viral Removal demands or to request a proposal, please contact us.
For Research Use Only. Not For Clinical Use.