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.
iSpeak Blog
Biotech Sessions at the 2025 ISPE Europe Annual Conference Highlight ATMPs including Large Molecules and Cell and Gene Therapies
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large…
Video
Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
iSpeak Blog
Unlock Industry Expertise with Free Access to ISPE’s Select Guidance Documents: A Key Membership Benefit
The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying…
iSpeak Blog
Diverse Case Studies at the 2025 ISPE Aseptic Conference
As aseptic processing evolves rapidly both from technological and regulatory perspectives, the 2025…
iSpeak Blog
A Message from the 2025 ISPE Europe Annual Conference Chair
The 2025 ISPE Europe Annual Conference will take place from Monday, 12 May to Wednesday, 14 May 2025…
iSpeak Blog
Technology and Innovation: The Spirit of Discovery
Space Exploration and Pharmaceutical Science: An Unlikely Pairing? Many years ago, during my high…
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
iSpeak Blog
The Power of Connection: Building Knowledge, Community, and Impact at ISPE
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into…
PE Articles
Indian Pharmaceutical Industry: Creating Global Impact
India’s pharmaceutical sector is not only a cornerstone of its national economy, but it’s also a…
iSpeak Blog
Announcing Pharma 4.0™ and Digitalization Transformation Track at the 2025 ISPE Europe Annual Conference in London, United Kingdom
The future of the pharmaceutical industry is being shaped by rapid advancements in digital…
iSpeak Blog
From the Sidelines to the Field: Career Growth Through Industry Engagement
Imagine your favorite sports team. Maybe it’s a football club with a rich history, a devoted fan…
iSpeak Blog
ISPE Members: Optimize Your Membership Experience with ISPE Engage
Unlock the Power of ISPE Engage: Your Essential Networking and Technical Hub As an ISPE member, one…
iSpeak Blog
Biotech Sessions at the 2025 ISPE Europe Annual Conference Highlight ATMPs including Large Molecules and Cell and Gene Therapies
The biotech sector, which includes advanced therapy medicinal products (ATMPs) including large…
Video
Actively Identifying Limiting Factors in Speed to Launch Drug Products
Actively Identifying Limiting Factors in Speed to Launch Drug Products Complimentary Learning Level…
iSpeak Blog
Unlock Industry Expertise with Free Access to ISPE’s Select Guidance Documents: A Key Membership Benefit
The pharmaceutical industry is one of the most dynamic and regulated fields globally, where staying…
iSpeak Blog
Diverse Case Studies at the 2025 ISPE Aseptic Conference
As aseptic processing evolves rapidly both from technological and regulatory perspectives, the 2025…
iSpeak Blog
A Message from the 2025 ISPE Europe Annual Conference Chair
The 2025 ISPE Europe Annual Conference will take place from Monday, 12 May to Wednesday, 14 May 2025…
iSpeak Blog
Technology and Innovation: The Spirit of Discovery
Space Exploration and Pharmaceutical Science: An Unlikely Pairing? Many years ago, during my high…
iSpeak Blog
GAMP® at the 2025 ISPE Europe Annual Conference: Where Quality, AI and Compliance Meet
In today’s rapidly evolving pharmaceutical landscape, advancing technologies, shifting regulatory…
iSpeak Blog
The Power of Connection: Building Knowledge, Community, and Impact at ISPE
In the pharmaceutical industry, expertise is essential—but connection is what turns expertise into…
PE Articles
Indian Pharmaceutical Industry: Creating Global Impact
India’s pharmaceutical sector is not only a cornerstone of its national economy, but it’s also a…
iSpeak Blog
Announcing Pharma 4.0™ and Digitalization Transformation Track at the 2025 ISPE Europe Annual Conference in London, United Kingdom
The future of the pharmaceutical industry is being shaped by rapid advancements in digital…
Guidance Documents
Active Pharmaceutical Ingredients (1)
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+Investigational Products (1)
+Knowledge Management (4)
+Lifecycle Management (1)
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+Project Management (6)
+Quality Assurance (3)
+Supply Chain Management (1)
+Community Discussions
Community Discussions
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Artificial Intelligence
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Mar 20, 2025
Data Integrity
Mar 14, 2025
Advanced Manufacturing
Critical Utilities
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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Coming Soon and Recently Published ISPE Guidance Documents
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Pharmaceutical Compounding: A US FDA Perspective
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Mexico to Recognize GMP Certifications from North, South American Authorities
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UK Launches Monthly Bulletins on Device, Drug Safety
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Inside Africa's Plan to Produce Vaccines Locally
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Pharma Companies Developing Protein Interaction Prediction Model
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CDMO Building 2nd Manufacturing Facility in Portugal
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Flexible Robot can Automate Medical Device Manufacturing
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New Method May Improve CHO Efficiency
- How Digital Shadows Can Enhance Downstream Processing
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Engineering Magazine Articles
Industry Perspectives on Practical Application of Platform Analytical Procedures
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development…
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
Cell Culture Media Manufacturing Controls for Bio-Manufacturing
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a…
Building Better Therapies With Antibody Engineering
Antibody engineering has transformed the development of therapeutic antibodies, enabling the…
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
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…
Potency Measurements for Cellular and Gene Therapy Products
Cell and gene therapy (C>) products address various diseases at the cellular or genetic level…
Industry Perspectives on Practical Application of Platform Analytical Procedures
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development…
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
Cell Culture Media Manufacturing Controls for Bio-Manufacturing
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a…
Building Better Therapies With Antibody Engineering
Antibody engineering has transformed the development of therapeutic antibodies, enabling the…
Continuous Buffer Management System: Large-Scale Buffer Preparation
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they…
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…
White Papers
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…
Stage 3 Process Validation: Applying Continued Process Verification Expectations
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and…
