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CMC Regulatory Expectations for Biological Therapeutic …

WEB7 General CMC considerations in IND development o For initiation of a Phase I study, product safety is the first and utmost consideration (e.g., viral clearance, …

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URL: https://www.casss.org/docs/default-source/cmc-strategy-forum-china/2021-cmc-china-speaker-presentations/speaker-presentation-jing-xianghong-emily-cder-fda-2021.pdf?sfvrsn=8f9a37d4_6

Project ORBIS: Opportunities and Challenges from the CMC …

WEBParticipation by both Biologic and Radiopharmaceutical Drug Directorate (BRDD; biologics) and Therapeutic Product Directorate (TPD; small molecules) Products are either new …

Category:  Health Go Health

Lessons Learned: Compatibility and In-Use Stability Studies

WEBA potency assay might be the only viable approach to assess protein concentration and drug product degradation for dilute products. other methods may not be sufficiently …

Category:  Health Go Health

World Mental Health Day

WEBOctober 10 is World Mental Health Day. The World Health Organization (WHO) recognizes this day each year to raise awareness about mental health all over the world and to …

Category:  Health Go Health

Microbial Challenge In-use Studies

WEBSpeaker Presentation Leiske Seagen Inc. Zamiri Genentech 2022 Microbial Challenge In-use Studies - Industry efforts to harmonize strategies in collaboration with Health …

Category:  Health Go Health

Emergence and Advancement of Technologies: Regulatory

WEBRegulation of Gene and Cell Therapy Products in Canada (cont’d) Cell and Gene Therapeutic Products. Regulated as Biologics, in Schedule D (Biologic Drugs) of the …

Category:  Health Go Health

Health Canada Implementation of ICH Q12: CMC Changes

WEBIntroduction of the Level III – Immediate Notification reporting category will allow the notification of changes in a timely manner of the changes that have been …

Category:  Health Go Health

Singapore’s New Cell, Tissue and Gene Therapy Products …

WEBSingapore’s New Cell, Tissue and Gene Therapy Products Regulations. Home / Papers and Presentations / Resource. In This Section. Papers and Presentations. Share this article: …

Category:  Health Go Health

Health Canada: Update on Regulatory Activities & Priorities

WEBRegulatory Priorities Examining our review system to determine the best approaches to: • better respond to healthcare system needs, and • improve timely access to effective …

Category:  Health Go Health

Microbial Challenge In-use Studies- Industry efforts on …

WEB| 5 Proprietary Microbial challenge studies evaluate potential for microbial growth • Holding product after breach of sterility represents a risk, in-use storage time …

Category:  Health Go Health

Phase Appropriate GMP Expectations for Analytical Methods …

WEBPhase Appropriate Expectations for Analytical Methods and Process Validation for Expedited Programs: A Regulatory Perspective Megan Powdrill, Ph.D –Biologist/Evaluator

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Accelerating Medicines Partnership

WEBProgram Development Team Identified Major Challenges to Effective Access to Gene Therapy. •. Challenges. •. Opportunity. Lack of understanding of the viral life cycle and …

Category:  Health Go Health

Technology Transfer Approach

WEBTechnology Transfer Introduction. 5. • ICH Q10 defines technology transfer as a stage of the product development life cycle: “The goal of technology transfer activities is to …

Category:  Health Go Health

Roundtable 35: Microbial Challenge In-use Studies and

WEBRoundtable 35: Microbial Challenge In-use Studies and Requirements Facilitator: Camellia Zamiri, Genentech, a Member of the Roche Group, South San Francisco, CA, USA …

Category:  Health Go Health

Multiproduct Facility Design and Control for Biologics

WEB2 BioProcess International 10(11)s De c e m b e r 2012 Fl e x-Facilities Design Multiproduct Facility Design and Control for Biologics Challenges and Considerations Bo Chi, Julia …

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Table 3: Host Cell Proteins Identification, Strategies

WEBTable 3: Host Cell Proteins – Identification, Strategies, Successes and Challenges Facilitators – Dawn Kelly, Merck & Co., Inc. Mark Paciga, Merck & Co., Inc. Scope: Host …

Category:  Health Go Health

January 24, 2023

WEBMicrosoft Word - WCBP 2023 Final Program. 08:00 - 08:30. CASSS Welcome and the 11th Annual William Hancock Award. Presented by: Julia Edwards, Genentech, a Member of …

Category:  Health Go Health

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