[Technical Seminar] Virus Removal Inactivation Process and Safety Testing for Biopharmaceuticals
Revisions of ICH Q5A (R2) and Future Perspectives on Virus Safety Evaluation
This seminar will explain the virus removal and inactivation processes and safety testing in the biopharmaceutical manufacturing process. It will cover standards for biological raw materials, clearance tests for foreign infectious substances such as viruses, other safety tests, standard manufacturing methods for biopharmaceuticals, tests related to various infectious substances targeting cell banks, raw material management, virus clearance and its evaluation in the purification process, and some revised points of the ICH-Q5A guidelines (R2) along with future prospects. *For more details, please check the related links or the seminar details in the catalog.
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<Event Information> Format: Live Streaming (Zoom) / Archive Streaming Date and Time: 【LIVE Streaming】June 18, 2026 (Thursday) 13:00 - 16:30 【Archive Streaming】June 22 - July 6 (Available for viewing as many times as desired during this period) Participation Fee: 29,700 yen per person (tax included) Instructor: Masahiko Katayama, Ph.D. (Medical Doctor)
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<Seminar Program (Tentative)> Chapter 1: Introduction Chapter 2: Overview of Standard Manufacturing Methods for Biopharmaceuticals (e.g., Antibody Drugs) Chapter 3: Testing for Various Infectious Substances Targeting Cell Banks Chapter 4: Management of Raw Materials Chapter 5: Virus Clearance in the Purification Process and Its Evaluation Chapter 6: Key Points of Amendments in ICH-Q5A Guidelines (R2) and Future Prospects
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