Content focuses on the interactions of multidisciplinary functions and discusses the scientific application of experimental design methodologies as part of the product manufacturing process. Individual topics could include formulation, clinical phases, manufacturing, technology transfer, production scale-up, and optimization.
PE Articles
Lessons from a Cost of Goods Analysis Workshop
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing…
PE Articles
Resilience for Cell Therapy Manufacturers: Five Strategies
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly…
PE Articles
Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access
Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable…
PE Articles
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
Video
Sterilizing-grade Filter Validation
Sterilizing-grade Filter Validation Complimentary Learning Level: Advanced Session Length: 1 hour…
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
A Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from…
Video
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…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
News
How Modeling Predicts Bottlenecks in Takeda's Multimodal Facilities
Minhazuddin Mohammed, Senior Manager of Process Engineering at Takeda’s Massachusetts Biologic…
PE Articles
Continuous Viral Vector Manufacturing
A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene…
Video
AI as the Catalyst for Biomanufacturing Excellence
AI as the Catalyst for Biomanufacturing Excellence Complimentary Learning Level: Intermediate…
PE Articles
Lessons from a Cost of Goods Analysis Workshop
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing…
PE Articles
Resilience for Cell Therapy Manufacturers: Five Strategies
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly…
PE Articles
Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access
Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable…
PE Articles
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
Video
Sterilizing-grade Filter Validation
Sterilizing-grade Filter Validation Complimentary Learning Level: Advanced Session Length: 1 hour…
iSpeak Blog
Igniting Innovation in the East: Reflections on ISPE’s Launch in China
A Message from the President and CEO, ISPE A New Chapter for ISPE in China: Reflections from…
Video
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…
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
News
How Modeling Predicts Bottlenecks in Takeda's Multimodal Facilities
Minhazuddin Mohammed, Senior Manager of Process Engineering at Takeda’s Massachusetts Biologic…
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Jun 19, 2025
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Pharmaceutical Water Systems Certificate Program from ISPE Academy
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ISPE Webinar: Quality Risk Management (QRM) Based Integrated Commissioning and Qualification (C&Q) Series: System Boundaries and System Classification
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Pharma Exec to Lead US FDA's Drug Center
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Compliance Deadline Extended for EtO Sterilization Rule
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What AI Can and Can't Do for Knowledge Workers in Biopharma
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iSpeak Blog Posts
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Pharmaceutical Engineering Magazine Articles
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Reevaluating Transfer of RTU Containers Into Grade A
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines…
ISPE Announces Sustainability Community of Practice
Governments around the world have made international commitments to reduce their environmental…
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
Continuous Viral Vector Manufacturing
A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene…
Lessons from a Cost of Goods Analysis Workshop
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing…
Resilience for Cell Therapy Manufacturers: Five Strategies
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly…
Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access
Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable…
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
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…
Indian Pharmaceutical Industry: Creating Global Impact
India’s pharmaceutical sector is not only a cornerstone of its national economy, but it’s also a…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Reevaluating Transfer of RTU Containers Into Grade A
At first glance, ready-to-use (RTU) primary packaging material (tub systems) give production lines…
ISPE Announces Sustainability Community of Practice
Governments around the world have made international commitments to reduce their environmental…
3R Initiative Within Roche’s Global QC Network
This article describes the numerous activities in the commercial quality control (QC) network that…
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
Continuous Viral Vector Manufacturing
A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene…
Lessons from a Cost of Goods Analysis Workshop
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing…
Resilience for Cell Therapy Manufacturers: Five Strategies
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly…
Unlocking ATMPs: Reducing Cost as an Obstacle to Patient Access
Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable…
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
White Papers
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
November / December 2023
There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
May / June 2022
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to…
