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
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Product
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
Published: July 2024 Pages: 258 Table of Contents Special Pricing for Emerging Economies Advances in…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
PE Articles
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
PE Articles
Potency Measurements for Cellular and Gene Therapy Products
Cell and gene therapy (C>) products address various diseases at the cellular or genetic level…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
iSpeak Blog
Elevate Your Career and Stay Ahead: Join Industry Leaders at the 2024 ISPE Annual Meeting & Expo
As the pharmaceutical landscape rapidly evolves, staying informed and connected with industry…
iSpeak Blog
Message From the Chair: Why Attend the 2025 ISPE Facilities of the Future Conference
The 2025 Facilities of the Future Conference will explore innovations in facility design and…
iSpeak Blog
Innovation Meets Talent: 2024 ISPE Annual Meeting & Expo Tackles the Future of Pharmaceutical Workforce
The unstoppable progress in technology and scientific knowledge is reshaping our industry. It is…
iSpeak Blog
Navigating the Latest US FDA Draft Guidelines on Use of Decentralized Clinical Trial Designs
The landscape of clinical trials has evolved significantly with the pandemic and interest in…
iSpeak Blog
The Pharmaceutical Industry’s Mission to Advance the Next Generation of Medicines in Collaboration with Regulators
The ongoing evolution of the pharmaceutical industry, aimed at propelling the next generation of…
Video
Attend the 2024 ISPE Annual Meeting & Expo
Attend the 2024 ISPE Annual Meeting & Expo Our comprehensive education program offers cutting-edge…
Product
GAMP Good Practice Guide: Computerized GCP Systems & Data 2nd Edition
Published: July 2024 Pages: 258 Table of Contents Special Pricing for Emerging Economies Advances in…
iSpeak Blog
Unlock New Insights and Innovations: Explore the 2024 ISPE Annual Meeting & Expo Education Tracks
The 2024 ISPE Annual Meeting & Expo is the pharmaceutical industry’s gateway to discovering the…
PE Articles
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
PE Articles
Potency Measurements for Cellular and Gene Therapy Products
Cell and gene therapy (C>) products address various diseases at the cellular or genetic level…
iSpeak Blog
Pharma 4.0™ and Annex 1 – The Perfect Fit
What do the EU GMP Annex 1 and the ISPE Baseline Guide Volume 8: Pharma 4.0™ (First Edition) have to…
iSpeak Blog
Unleash Your Potential at the 2024 ISPE Annual Meeting & Expo: Dive into Cutting-Edge Expertise and Unrivaled Networking Opportunities
As the global pharmaceutical industry continues to evolve, staying ahead of the curve is more…
Guidance Documents
Active Pharmaceutical Ingredients (1)
+Drug Shortages (1)
+Investigational Products (1)
+Knowledge Management (4)
+Lifecycle Management (1)
+Process Analytical Technology (1)
+Project Management (6)
+Quality Assurance (3)
+Supply Chain Management (1)
+Community Discussions
Community Discussions
Apr 08, 2025
Validation
Apr 08, 2025
Data Integrity
Apr 07, 2025
Advanced Manufacturing
Biotechnology
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Mar 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Mar 20, 2025
Mar 20, 2025
Webinars
Upcoming
On-Demand
ISPE in the News
Latest
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ISPE Members: Volunteer with ISPE
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ISPE Webinar: QRM Based Integrated C&Q Series - Engineering Change Management (ECM)
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Belgian Regulators Sharpen ATMP Expertise
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AI Can Streamline Quality Auditing
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Novartis Plans $23B US Investment
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Buffer Recycling Feasible in Downstream Processes
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Automation, AI Could Cut CGT Production Costs
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Experts Present Framework for PAT in Biopharma Manufacturing
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ISPE Delivers ICH Q12 Training to Singapore's Health Authority
- Coming Soon and Recently Published ISPE Guidance Documents
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Engineering Magazine Articles
Evolving China’s Regulatory System in Alignment with ICH
With the Chinese government initiating drug regulatory reform in 2015 and China joining the…
Using Industry Survey Data to Shape Cell Therapy Facility Design
Cell therapies have been used to treat thousands of patients worldwide ever since the CAR T cell…
ATMP-Focused Online Seminars Educate and Inspire
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements…
Live Biotherapeutic Products: Moving the Microbiome to the Patient
Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However…
Comparability Considerations for Cellular & Gene Therapy Products
Cell and gene therapy (C>) products comprise a rapidly growing field of innovative medicines 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…
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…
Post-Approval Change Management for Cell and Gene Therapy Products
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and…
Evolving China’s Regulatory System in Alignment with ICH
With the Chinese government initiating drug regulatory reform in 2015 and China joining the…
Using Industry Survey Data to Shape Cell Therapy Facility Design
Cell therapies have been used to treat thousands of patients worldwide ever since the CAR T cell…
ATMP-Focused Online Seminars Educate and Inspire
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements…
Live Biotherapeutic Products: Moving the Microbiome to the Patient
Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However…
Comparability Considerations for Cellular & Gene Therapy Products
Cell and gene therapy (C>) products comprise a rapidly growing field of innovative medicines 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…
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…
White Papers
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…
Lifecycle Approach to Biotech Process Validation
This discussion paper proposes ideas for answering the questions about the application of the…
Stage 3 Process Validation: Applying Continued Process Verification Expectations
This discussion paper proposes ideas for answering the questions “How is Stage 3 monitoring and…
