Good Practice Guide: Continuous Manufacturing of Biological Products
Published: December 2025
Pages: 200
Biopharmaceutical manufacturing is entering a new era—one defined by agility, efficiency, and smarter operations. As the industry shifts toward continuous manufacturing (CM) for large-molecule drug substances, companies are unlocking transformative benefits: streamlined production, reduced costs, faster response to market demands, and enhanced product quality.
The ISPE Good Practice Guide: Continuous Manufacturing of Biological Products is designed for innovators, decision-makers, and technical leaders who are driving this change. It offers a strategic lens into the evolution of continuous biomanufacturing (CBM), highlighting the practical solutions and proven frameworks that are reshaping how biologics are made. From hybrid platforms to advanced control strategies, this resource showcases how manufacturers are overcoming challenges and building scalable, compliant, and patient-focused operations.
Guide Core Team
For the full list of contributors to this Guide see Guidance Document Teams
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