Networking Opportunities
ISPE sponsors several conferences each year. The 2025 ISPE Europe Annual Conference took place 12-14 May in London, England, UK, where industry experts and thought leaders in the pharmaceutical and biopharmaceutical industries, and global regulatory agencies met for four days. Also taking place this spring, the 2025 ISPE Biotechnology Conference, 2–3 June in Boston, Massachusetts, US. The 2025 ISPE Annual Meeting & Expo will take place 26-29 October in Charlotte, North Carolina, US. Featured speakers include John Daniel, a Human Resources Executive and author of Ancestral Mindset, a book that explores leadership and teamwork from an evolutionary-neurological perspective; Brendan O’Callaghan, Executive Vice President of Manufacturing and Supply at Sanofi; and Elaine Shannon, Global Quality Officer at Takeda.
Real-World Insights with ISPE Guidance Documents
ISPE has published over 80 guides with pharmaceutical industry experts who offer practical, real-world insights from industry best practices to regulatory expectations. Guidance documents cover a wide range of topics, arming professionals with best practices and regulatory insights that meet specific needs.
Biopharmaceutical-Focused Guides
ISPE publishes a variety of guides for professionals in biopharmaceuticals. For example, the ISPE Guide: Biopharmaceutical Process Development and Manufacturing offers a universal roadmap for developing cost-effective, regulated biopharmaceutical manufacturing processes that meet their intended use in a timely manner. The Guide focuses on the development, process approaches, and best practices for manufacturing biopharmaceutical products.
The ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products provides a comprehensive overview of product and process development, manufacturing, investigational product supply chain management, quality control/quality assurance, and global regulatory requirements for biopharmaceuticals.
The ISPE Baseline® Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities (Third Edition) includes key discussion points on integrating quality risk management into biopharmaceutical manufacturing to reduce risk and enhance control strategies. It also contains an in-depth analysis of contamination control strategies and their impact on facility design and operational procedures and an exploration into how closed processes influence facility design.
ATMP-Focused Guides
ATMPs are a fast-growing field of interest in the pharmaceutical industry, with many ATMPs in development and continual growth projected. ATMP therapies include gene therapies, somatic-cell therapy, and tissue-engineered medicines, for example. ISPE ATMP-related guides cover allogeneic cell therapy, autologous cell therapy, and recombinant adeno-associated virus manufacturing (rAAV) manufacturing and comparability.
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy focuses on the development and design of manufacturing facilities for these therapies. It provides answers to common challenges faced in allogeneic cell therapy facilities, explores design concepts tailored for these facilities, and presents valuable insights into GMP layout and architectural design development.
The ISPE Guide: Advanced Therapy Medicinal Products – Autologous Cell Therapy primarily focuses on the development and design of manufacturing facilities for autologous cell therapies for parenteral use. The Guide offers an in-depth overview of the key components necessary for designing ATMP facilities. It also explains how unique characteristics and requirements of the manufacturing process and the facility must be specifically aligned for ATMPs.
The ISPE Guide: Advanced Therapy Medicinal Products – Recombinant AAV Comparability and Lifecycle Management outlines best practices for rAAV comparability exercises, equipping manufacturers with a standardized approach for developing process and product comparability strategies.
Professional Development Training
From an overview of biopharmaceutical manufacturing processes to ATMP manufacturing, ISPE offers a range of professional development training opportunities for both newer and seasoned professionals. For more information about these and other benefits of an ISPE membership, email ask@ISPE.org
Join ISPE Today
Becoming a member of ISPE offers numerous benefits, including access to a vast network of professionals, exclusive training events, and valuable resources. As a member, you'll join more than 22,000 of your professional peers from over 120 countries in advancing solutions that lead to improved patient health. Membership provides access to 20+ complimentary ISPE Good Practice Guides, a robust library of on-demand training and e-learning resources, and much more. Learn more and consider joining today.
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