ICH Q5A (R2) Revision: Seminar on Viral Safety Evaluation for Biopharmaceuticals
The IR Institute of Technology Education will hold an online seminar on viral safety evaluation in biopharmaceutical manufacturing processes. It will cover key revision points of ICH Q5A (R2) and practical trends in viral safety assessment, targeting engineers and experts in related industries.
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The IR Institute of Technology Education will host an online public seminar focusing on virus removal/inactivation processes and safety testing in biopharmaceutical manufacturing, specifically addressing the revised points of ICH Q5A (R2) and practical trends in viral safety evaluation.
Biopharmaceuticals inherently carry risks of pathogen contamination originating from raw materials and manufacturing processes, primarily due to expression in animal cells. Among these, viral contamination in cell banks and intermediates can be challenging to identify. Therefore, ensuring safety requires an appropriate combination of negating contamination at the raw material stage and evaluating removal (clearance) during the purification process.
Furthermore, the revised version (R2) of the ICH Q5A guideline has achieved trilateral agreement, and partial revisions have been issued by the Ministry of Health, Labour and Welfare in Japan, making the organization and updating of viral safety evaluation critically important.
Seminar Overview
Seminar Name: Viral Removal/Inactivation Processes and Safety Testing in Biopharmaceutical Manufacturing
Format: Online (LIVE streaming via Zoom + Archive streaming)
Date & Time:
* [LIVE Streaming] Thursday, June 18, 2026, 13:00-16:30
* [Archive Streaming] June 22 - July 6 (available for viewing multiple times during the period)
Participation Fee: 29,700 JPY (incl. tax) / per person (group discounts available)
Lecturer: Dr. Masahiko Katayama (Medical Doctor)
Course Details
This seminar will organize viral safety evaluation in biopharmaceutical manufacturing processes from the perspectives of raw materials, cell banks, purification processes, and guideline revisions.
Seminar Program
* Introduction:
Various modalities and manufacturing processes, challenges in stable production, importance of viral safety evaluation
* Overview of Standard Manufacturing Methods:
Expression cell construction, Cell Stability Test, condition determination by DoE, scale-up considerations
* Testing for Cell Banks:
Characterization of MCB/WCB, EoPC and unprocessed/unpurified bulk testing, electron microscopy observation
* Raw Material Management:
Adventitious agents and traceability, biological raw material standards, media HTST/UV-C treatment, filter utilization, considerations for new modalities
* Viral Clearance and Evaluation in Purification Processes:
Low pH treatment, scale-down models, reusable columns, nanofiltration (integrity testing, process control)
* ICH Q5A (R2) Revision Points and Future Outlook:
Revision history, continuous manufacturing, alternative methods to animal testing/molecular biological methods, utilization of prior knowledge, future industry trends
Target Audience
* Those involved in biopharmaceutical development projects at pharmaceutical companies and startups
* Those involved in quality control / production management / CMC regulatory affairs for biopharmaceuticals
* Those with basic knowledge of biochemistry, cell biology, and protein structure analysis at universities, etc. (easy-to-understand explanations are also planned for beginners)
*For more details on this seminar, please visit:
https://nihon-ir.jp/seminar/biopharmaceutical_virus-removal_inactivation-process_safety-testing/
The IR Institute of Technology Education will continue to provide practical knowledge and know-how through technical education services (seminars, e-learning, training, publishing) for the manufacturing industry.
Nihon IR Co., Ltd.
In addition to patent and intellectual property solutions with over 50 years of experience, Nihon IR Co., Ltd. offers a wide range of highly specialized practical services centered on technology, including technical information research and analysis, technical education for the manufacturing industry, and technical content creation.
* Company Website: https://nihon-ir.jp/
* IR Institute of Technology Education: https://engineer-education.com/
15-1 Kanda Iwamotocho, Chiyoda-ku, Tokyo 101-0033, Japan
TEL: 03-6206-4966
Biopharmaceuticals inherently carry risks of pathogen contamination originating from raw materials and manufacturing processes, primarily due to expression in animal cells. Among these, viral contamination in cell banks and intermediates can be challenging to identify. Therefore, ensuring safety requires an appropriate combination of negating contamination at the raw material stage and evaluating removal (clearance) during the purification process.
Furthermore, the revised version (R2) of the ICH Q5A guideline has achieved trilateral agreement, and partial revisions have been issued by the Ministry of Health, Labour and Welfare in Japan, making the organization and updating of viral safety evaluation critically important.
Seminar Overview
Seminar Name: Viral Removal/Inactivation Processes and Safety Testing in Biopharmaceutical Manufacturing
Format: Online (LIVE streaming via Zoom + Archive streaming)
Date & Time:
* [LIVE Streaming] Thursday, June 18, 2026, 13:00-16:30
* [Archive Streaming] June 22 - July 6 (available for viewing multiple times during the period)
Participation Fee: 29,700 JPY (incl. tax) / per person (group discounts available)
Lecturer: Dr. Masahiko Katayama (Medical Doctor)
Course Details
This seminar will organize viral safety evaluation in biopharmaceutical manufacturing processes from the perspectives of raw materials, cell banks, purification processes, and guideline revisions.
Seminar Program
* Introduction:
Various modalities and manufacturing processes, challenges in stable production, importance of viral safety evaluation
* Overview of Standard Manufacturing Methods:
Expression cell construction, Cell Stability Test, condition determination by DoE, scale-up considerations
* Testing for Cell Banks:
Characterization of MCB/WCB, EoPC and unprocessed/unpurified bulk testing, electron microscopy observation
* Raw Material Management:
Adventitious agents and traceability, biological raw material standards, media HTST/UV-C treatment, filter utilization, considerations for new modalities
* Viral Clearance and Evaluation in Purification Processes:
Low pH treatment, scale-down models, reusable columns, nanofiltration (integrity testing, process control)
* ICH Q5A (R2) Revision Points and Future Outlook:
Revision history, continuous manufacturing, alternative methods to animal testing/molecular biological methods, utilization of prior knowledge, future industry trends
Target Audience
* Those involved in biopharmaceutical development projects at pharmaceutical companies and startups
* Those involved in quality control / production management / CMC regulatory affairs for biopharmaceuticals
* Those with basic knowledge of biochemistry, cell biology, and protein structure analysis at universities, etc. (easy-to-understand explanations are also planned for beginners)
*For more details on this seminar, please visit:
https://nihon-ir.jp/seminar/biopharmaceutical_virus-removal_inactivation-process_safety-testing/
The IR Institute of Technology Education will continue to provide practical knowledge and know-how through technical education services (seminars, e-learning, training, publishing) for the manufacturing industry.
Nihon IR Co., Ltd.
In addition to patent and intellectual property solutions with over 50 years of experience, Nihon IR Co., Ltd. offers a wide range of highly specialized practical services centered on technology, including technical information research and analysis, technical education for the manufacturing industry, and technical content creation.
* Company Website: https://nihon-ir.jp/
* IR Institute of Technology Education: https://engineer-education.com/
15-1 Kanda Iwamotocho, Chiyoda-ku, Tokyo 101-0033, Japan
TEL: 03-6206-4966