Embarking on the Journey to Market with Confidence®
Introduction
Virus clearance studies are pivotal in bringing biologics to the market, ensuring the robustness of purification procedures against viral contamination. With its Confidence® Validation Services, Biotech Verde offers GLP virus clearance studies and expert consultation, providing a quicker path to achieving high log reduction values (LRV)
Key Advantages
Fast Turnaround
Rapid completion with a 9-week turnaround time for a typical GLP phase I study.
Highly Purified Viruses
Employing highly purified viruses for accurate and reliable results.
Proven Experience
Leveraging years of experience in virus clearance studies.
Customer-Focused Services
Tailored solutions and expert consultation to meet your specific needs.
Consolidated Solutions
Comprehensive services covering various aspects of virus clearance.
The Fundamentals of Virus Clearance Studies
Learn about the basic principles of virus clearance studies and gain insights into the critical aspects of conducting studies with Biotech Verde. Explore the video to understand more about our virus clearance service offering.
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Importance of Virus Clearance Studies
Patient Safety
The ultimate goal is patient safety, guarding against potential harm and drug shortages.
Regulatory Requirement
A regulatory requirement to demonstrate a manufacturer’s ability to handle unexpected viral contaminants.
FDA Guidance
Retrovirus clearance studies are recommended before Phase 1 trials.
Clearance studies for other viruses before Phase 2/3 trials are subject to process changes.
[Source: FDA-1994-D-0318]
ICH Q5A
Emphasizes careful design of viral clearance studies using different methods for maximum clearance.
Evaluation studies are performed to clear known viruses and provide assurance against undetected or potential adventitious viruses.
[Source: ICH Q5A]
EMEA/CHMP/BWP
Phase I studies require evaluation for enveloped and non-enveloped viruses.
Significant changes in manufacturing may necessitate additional virus studies.
[Source: EMEA/CHMP/BWP/398498/2005]
Confidence® Virus Clearance Services Packages
Biotech Verde combines expertise in virus clearance services with specific clearance technologies, offering a holistic solution. Our services, often paired with Virosart® virus filters, Sartobind® membrane adsorbers, and CIM® monoliths, ensure a comprehensive approach.
GLP Virus Clearance Studies
Regulatory-required studies for investigational new drug (IND) submissions before biologics license application (BLA). She is examining the ability to remove or inactivate viruses.
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Feasibility Studies
A thorough investigation of existing process challenges before GLP studies. They are preventing delays in product development by ensuring good results.
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Learn More About Virus Clearance Validation Services
Common Challenges in Completing Virus Clearance Validation Studies
Discover the unique challenges in virus clearance validation studies and how to overcome them to ensure optimal purification results.
[Read Blog Post]
Webinars
1. Preventing Unexpected Results in a GLP Study
Learn how Virus Clearance Feasibility Studies can help avoid development delays and cost overruns.
[Watch Webinar Online]
2. Ensuring High Virus Clearance Using AEX Membrane Adsorbers
Gain insights into best practices for optimizing and sizing AEX membrane adsorbers for purification processes.
[Watch Webinar Online]
Related Assets
Case Study
Virus Clearance Studies Demonstrate Robust Performance of Sartobind® Q at High Loading
Flyer
Confidence Virus Clearance Service Flyer
Related Topics
Explore a spectrum of relevant subjects and stay informed with our comprehensive resources on the latest advancements in the field.
Virus Clearance
Process Chromatography
Monolithic Chromatography
Virus Clearance:
Safeguard your processes with our cutting-edge virus clearance solutions, ensuring the purity and safety of your biopharmaceutical products.
Process Chromatography:
Optimize your separation processes and enhance product purity through our advanced and tailored process chromatography solutions.
Monolithic Chromatography:
Experience efficiency and speed in chromatographic separations with our innovative monolithic chromatography techniques, revolutionizing your bioprocessing workflows.
Embark on your journey to market with Confidence® Virus Clearance Services – your trusted partner in ensuring the safety and success of biologic products.
