Baseline Guide Vol 6: Biopharmaceutical Manufacturing Facilities 3rd Edition


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Published: November 2023
Pages: 194

The biopharmaceutical industry has adapted to reflect available technologies such as single-use technologies and modular construction methodologies, products with more focused patient populations, evolving regulatory conditions, unrelenting pressures on costs, and increased focus on robust product supply while maintaining high-quality standards. This Guide presents concepts that reflect how these changes affect biopharmaceutical manufacturing facilities without sacrificing product quality, by reducing risk and enhancing the manufacturing control strategy.

This third edition of the  ISPE Baseline® Guide: Biopharmaceutical Manufacturing Facilities intends to further reinforce the concepts described in the second edition of the Guide, provide examples of how these concepts can be put into practice, and detail the value and benefits of the approaches described. In addition, this revision includes new topics and details regarding Quality Risk Management (QRM), Contamination Control Strategies (CCS), and the impact of closed processes on facility design.

The globally recognized concepts around product protection, driven by aseptic and low bioburden practices and closed system designs, provide the foundation for a risk-based approach that examines the relationship between product, process, and facility. This Guide is intended to provide individuals and teams with the tools to make informed decisions about layouts, area classifications, segregation strategies, project delivery approaches, and operational approaches, all aimed at creating compliant, cost-effective biomanufacturing facility assets.

Guide Core Team

Ronald A. Berk
Chief Technical Officer
Hyde Engineering + Consulting Inc
Jose A. Caraballo
VP Quality Systems, Compliance, and Quality Engineering
Kite Pharma, Inc.
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Carl Carlson
Senior Process Engineer
Genesis AEC
Vince Cebular
Senior Vice President, Compliance Services
Peter W. Cramer
Principle Process Architect/SME
Jacobs Engineering
Norman A. Goldschmidt
Genesis AEC
Jeffery N. Odum, CPIP
Practice Leader: ATMPs & Biologics
Genesis AEC
Brian Pochini, CPIP
Principal Engineer
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James A. Quinn, PE, CPIP
Mechanical Engineer
CRB Group
Mark S. Von Stwolinski, RA
Senior Fellow of Process Architecture
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Kelly Waldron
Business Unit Manager, Quality and Manufacturing Science Consulting
Valsource Inc

For the full list of contributors to this Guide see Guidance Document Teams