PE Magazine | May / June 2025
Streamlining the Vein-to-Vein Process: The Future of Automated Cell Therapy Manufacturing

Cell therapies, especially autologous chimeric antigen receptor T cell (CAR T cell) treatments, are transforming personalized medicine, bringing new hope to patients with conditions once thought untreatable.

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PE Magazine | May / June 2025
Final Preparation of ATMPs at Point of Care

ATMPs, which include cell and gene therapy (C&GT) products, frequently require handling steps between quality control release and patient administration. These steps take place directly at the point of care and are especially critical for C&GTs with limited shelf life after preparation.

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iSpeak Blog | 02 June 2025
A Visit to 中外製薬工業株式会社 Chugai’s Award-Winning Tokyo Facility: A Benchmark in Social Impact and Excellence

A Message from the President and CEO, ISPE - In late May, I had the distinct pleasure of visiting 中外製薬工業株式会社 Chugai Pharmaceutical Manufacturing Co., Ltd.’s UK4 biological drug substance manufacturing facility in Tokyo, Japan—Category Winner of the 2024 ISPE Facility of the Year Awards (FOYA) in Social Impact.

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Pharmaceutical Engineering® Reader Picks for April 2025
A Regulatory Surveillance and Advocacy Framework

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Baseline Guide Vol 8: Pharma 4.0
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Highlights From ISPE Knowledge Network

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Facilities & Equipment
  1. Driving Excellence in Pharma: Explore the Manufacturing, Quality Control, and Operational Excellence Track at the 2025 ISPE Annual Meeting & Expo
  2. Navigating the Horizon: ISPE’s Vision for Tomorrow
  3. ISPE's Role in Advancing Pharmaceutical Manufacturing
  4. When Analytics Meet Quality
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Information Systems
  1. Unlocking the Future of Pharma: Mentor ISPE Launches Expert Webinar Series with a Deep Dive into Machine Learning (ML)/Artificial Intelligence (AI) Case Studies
  2. AI as an Enabler for a Sustainable Quality Transformation
  3. Navigating the Horizon: ISPE’s Vision for Tomorrow
  4. ISPE's Role in Advancing Pharmaceutical Manufacturing
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Management
  1. Navigating the Horizon: ISPE’s Vision for Tomorrow
  2. ISPE's Role in Advancing Pharmaceutical Manufacturing
  3. When Analytics Meet Quality
  4. Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
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Product Development
  1. Navigating the Horizon: ISPE’s Vision for Tomorrow
  2. ISPE's Role in Advancing Pharmaceutical Manufacturing
  3. When Analytics Meet Quality
  4. Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
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Quality
  1. Driving Excellence in Pharma: Explore the Manufacturing, Quality Control, and Operational Excellence Track at the 2025 ISPE Annual Meeting & Expo
  2. Navigating the Horizon: ISPE’s Vision for Tomorrow
  3. ISPE's Role in Advancing Pharmaceutical Manufacturing
  4. When Analytics Meet Quality
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Regulatory
  1. Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference
  2. EMA Support for Innovation in Pharmaceutical Manufacturing
  3. Navigating the Horizon: ISPE’s Vision for Tomorrow
  4. ISPE's Role in Advancing Pharmaceutical Manufacturing
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Supply Chain
  1. Navigating the Horizon: ISPE’s Vision for Tomorrow
  2. ISPE's Role in Advancing Pharmaceutical Manufacturing
  3. When Analytics Meet Quality
  4. Empowering Biotech’s Future: Operational Readiness and Cultural Excellence Take Center Stage at the 2025 ISPE Biotechnology Conference
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Arlington, VA US

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Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing
Advancing Aseptic Processing: The Future of Flexible Solutions and Robotics in Pharma Manufacturing…
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems
Introduction to the 2nd Edition of the GAMP GPG on GCP Systems Complimentary Learning Level…
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection, Environment
Real Life Case Studies featuring ML/AI including Predictive Maintenance, Defect Detection…
How to Perform a Compliant Human Error Investigation
How to Perform a Compliant Human Error Investigation Complimentary Learning Level: Advanced Time…
Effective Process Validation Strategies for Successful Product Commercialization
Effective Process Validation Strategies for Successful Product Commercialization Complimentary…
Sterilizing-grade Filter Validation
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Life Cycle Approach to Process Validation- Stage 3 Implementation
Life Cycle Approach to Process Validation- Stage 3 Implementation Complimentary Learning Level…
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QRM Based Integrated C&Q Series - User Requirement Specification
QRM Based Integrated C&Q Series - User Requirement Specification Complimentary Learning Level…
AI as the Catalyst for Biomanufacturing Excellence
AI as the Catalyst for Biomanufacturing Excellence Complimentary Learning Level: Intermediate…
ISPE Tariff Forum
ISPE Tariff Forum Learning Level: Intermediate Session Length: 1.5 hours The ISPE Oral Solid Dosage…
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies
Disruptive Medicine Innovation: Next Generation of Combination Product Technologies Complimentary…
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control
AI/ML in Regulated Life Sciences (GxP) Sectors – Operation Phase: Maintaining a State of Control…
QRM Based Integrated C&Q Series - Engineering Change Management
QRM Based Integrated C&Q Series - Engineering Change Management Complimentary Learning Level…
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q
QRM Based Integrated C&Q Series - Good Engineering Practices as a Key Enabler for Integrated C&Q…
Navigating the PFAS Challenge in Pharma: Regulatory Landscape, Risk Management, and Health Implications
Complimentary Learning Level: Intermediate Session Length: 1 hour Per- and polyfluoroalkyl…
Complimentary Member Orientation and Benefits Webinar
Join us for the complimentary ISPE Member Orientation and Benefits webinar to unlock your membership…
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory
Automation Isn’t Automatic: Strategy for Designing and Building a Fully Autonomous Laboratory…
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense
QRM Based Integrated C&Q Series - New Program Initiation, Objections, Audit Defense Complimentary…
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning & Qualification
QRM Based Integrated C&Q Series - Implementing a Science and Risk Based Approach to Commissioning &…
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May / June 2025

May / June 2025

The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products, the costs associated with patient access, and readiness.
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