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A Guide to Viral Clearance-Strategies for Biopharmaceutical Safety


Description: Currently, the global market for biopharmaceuticals is valued at $41 billion and is estimated to grow at a compound annual rate of 21% over the past five years.

Over the years, biologicals obtained from mammalian blood and tissues have proven their therapeutic efficacy. The completion of the human genome project has opened the path to the design of personalized biological therapeutics. However, there remains the potential for the transmission of diseases, specifically viral, through any biological that uses a mammalian-derived component in the manufacturing process.

With regard to virological safety (which is a regulatory requirement), the current 'state-of-the-art' precludes making a claim of absolute absence of any viral presence in the product. The practical approach applied by regulatory bodies is safety evaluation on a 'case-by-case' basis, keeping in mind current virus contamination concerns (e.g., West Nile Virus) and the availability of adequate technologies for detection and clearance of these viral agents. Regulatory guidelines stress a holistic approach that includes appropriate sourcing of materials, demonstration of the capability of the manufacturing process for viral clearance, and in-process testing.

This Guide to Viral Clearance is intended to highlight regulatory requirements, facilitate understanding and appreciation for the philosophies that underlie these regulations, and provide a toolkit to the reader in order to evaluate viral clearance methods and design process validation studies to document their efficacy.

Questions Answered within this report:

- What should be the basis for evaluation of viral clearance methodologies?
- When do I start evaluating and planning to ensure my process includes adequate process steps for viral clearance?
- Do I conduct viral validation studies at process scale or on scaled-down models?
- How much viral clearance is 'enough'?

This Guide Will Greatly Benefit the Following Professionals:

Heads of Process Development, R&D, and Manufacturing within the pharmaceutical, biopharmaceutical, and biotechnology industries involved in the production, QC and QA of biologicals and biotech-derived products. Contract manufacturers whose input is sought for specifying viral clearance in the manufacturing process. Start-up companies who have limited knowledge of regulatory requirements.

In addition to Group Directors and Lab Directors within Universities who are focusing on R&D, and Physicians and Researchers within Hospitals who are involved in development of patient-specific therapies.


Contents: 1 Executive Summary


2 General Overview of Viruses
Brief Discussion of Viruses
Virus Contamination of Biologicals - Historical Perspective and Lessons Learnt
Products Requiring Viral Safety Assessment

3 Control of Production Processes for Viral Safety
General Considerations
Raw Materials
Cell Bank Production Characterization and Validation
Adventitious Contaminants

4 Virus Detection Methods
General
Types of Viral Detection Assays
Summary Comments

5 Regulatory Considerations: A Risk Based Approach to Viral Safety
General Considerations
Risk Assessment
Risk Minimization
Risk Management: How Much Viral Clearance is 'Enough'?
Summary Comments

6 Virus Clearance Methods
General Considerations
Virus Clearance Methods - Serendipitous Versus Deliberate
Virus Clearance Methods - Inactivation and Removal
Virus Removal Methods

7 Process Validation for Viral Clearance
General Considerations
Viral Clearance Evaluation (Validation) Studies
Virus Stock-related Considerations
Importance of Adequate Controls
Considerations in Data Interpretation and Estimating Viral Clearance
Viral Clearance Validation Studies: Pitfalls and Cautions
Summary Comments

8 Moving Forward - Summary Comments

9 List of Relevant Regulatory Documents

10 Glossary of Terms




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