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Viral Safety of Biotechnology Products – Changing the Regulatory Landscape, Modalities and Analytical Technologies - English

‐ Dec 6, 2022 11:00am

The ICH Q5A guideline considers testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. Since the Q5A(R1) was finalized in 1999, the manufacturing technology, product types, analytical methodology, and strategies for virus clearance have emerged and evolved over the past 20 years. The R1 guideline is still referred to actively and considered quite useful. However, it was recognized that a revision of the Q5A guideline was necessary to reflect the current scientific knowledge and biotechnology advances.

This year, the Q5A(R2) draft guideline reached Step 2 of the ICH process and has been published on the ICH Website for public consultation. The draft guideline reflects current scientific knowledge and biotechnology advances, for example, new product types in scope, new analytical methodologies and alternative testing approaches to align with the 3Rs principles, points to consider about viral safety for continuous manufacturing, the scientific principles to allow flexible strategies of testing and/or virus clearance including risk-based approach and applying prior knowledge. 

In this session, key points of the revised guideline will be explained, and the expected benefits or challenges in the virus clearance strategies and better viral safety supporting data will be discussed, from perspectives of regulator and industry including CROs with viral testing and virus clearance evaluation, in terms of both product types of emerging and with extensive manufacturing experiences. 

Key Questions:
-Concerning Q5A(R2) guideline, what kind of benefits and challenges are expected in virus clearance strategies or validation approach?
-Are there any challenges or expectation in terms of virus clearance strategy of emerging product type/class which will be scope of revised guideline, such as AAV?
-In terms of product type with extensive experiences of manufacturing such as Mab, are there any challenges or expectations concerning flexible and alternative approach of virus clearance and validation including prior knowledge?
-Are there any challenges or expectations to implement alternative virus detection method as replacement/supplement of existing assay?
-Are there any desirable suggestion or challenges concerning virus clearance strategies of continuous manufacturing process?

Session Speakers:
09:05 - 09:30
Concept of the ICH-Q5A Second Revision
Akira Sakurai, PMDA-Pharmaceuticals and Medical Devices Agency, Japan

09:30 - 09:55
An Industry Perspective on CHO Cell Product Virus Safety
Shohei Kobayashi, Chugai Pharmaceutical Co., Ltd., Japan

10:05 - 10:30
ICH Q5A (R2) Expansion of Scope to Include Viral Vectors: Application of Prior Knowledge for Adenovirus-Vectored Vaccines
Gilles Chénard, Janssen Vaccines & Prevention B.V., Netherlands

10:30 - 10:45
ICH-Q5A Update and Possible Impact on Approach to Virus Clearance Study
Munehisa Masuda, Merck Life Science

10:45 - 11:00
Progress of Blazar Platform with the Background of ICHQ5A R2
Huixing Feng, Merck Life Science

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