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
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…
PE Articles
Real-Time Process Monitoring: Why Have It and How to Get It
Real-time process monitoring involves integrating physical sensors into production processes to…
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…
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)
- Good Practice Guide: Technology Transfer 3rd Edition
- Good Practice Guide: Operations Management
- Good Practice Guide: Project Management for the Pharmaceutical Industry
- Good Practice Guide: Good Engineering Practice 2nd Edition
- Good Practice Guide: Management of Engineering Standards
- The Cultural Excellence Report - Six Key Dimensions
Quality Assurance (3)
Supply Chain Management (1)
Community Discussions
Community Discussions
Feb 10, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Feb 06, 2025
Feb 03, 2025
Jan 30, 2025
Jan 27, 2025
Jan 27, 2025
Regulatory
Regulatory
Jan 27, 2025
Information Systems
Webinars
ISPE in the News
Latest
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ISPE Training: Aseptic Processing and Annex 1 Training Course, In Person
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ISPE United Kingdom Affiliate 2024 Member of the Year: Chris Leman
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Oman Signs Purchase Agreements With 6 Drugmakers
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Hong Kong Funds Advanced Pharmaceutical Manufacturing
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Initiative Aims for RNA Vaccine Manufacturing in Egypt
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Labcorp Expands Somerset County, N.J., Facility
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MRPC Upgrades Cleanroom for Surgical Implant Components
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Recipharm Completes Production Run in Modular Sterile Filling System
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Comparison of Vaporized, Aerosolized H2O2 for Sterilization
- Iowa Biomanufacturing Center Receives $1M Grant
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Engineering Magazine Articles
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…
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…
Videos
Professional Development Training
ICH Q9(R1): Guidelines on Pharmaceutical Risk Management
Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. Course Price: $300 (non-member) / $270 (member) Buy Now Return to Online Learning
ICH Q6A: Specifications, Test Procedures, and Acceptance Criteria for New Drug Substances and Products
Delivery Mode: Webinar This course covers testing and quality control requirements in marketing authorization/new drug applications, emphasizing ICH guidelines. It focuses on ICH Q6A, detailing test procedures and acceptance criteria for new drug substances/products to ensure global consistency and safety. The course also integrates later guidelines (ICH Q8, Q9, Q10, Q11), introducing science and risk-based approaches. Participants will learn to navigate global marketing authorization/new drug applications, contributing to high-quality pharmaceutical product development. Buy Now Return to…
Biopharmaceuticals: Webinar C> e ATMP
Biopharmaceuticals: Webinar de treinamento em C> e ATMP Visão geral Este webinar é uma gravação do novo curso de instrutor que é um curso de nível avançado sobre therapies C e Gene T (C>) e Medicamentos de Terapia Avançada (ATMP). O curso também fornece umavisão geral dos componentes mais comuns e estabelecidos que são aproveitados em produtos C> (por exemplo, plasmídeos, mRNA, nanopartículas lipídicas, vetores virais), cobrindo terminologia, processos de fabricação e subsequente caracterização analítica de os componentes fabricados e os produtos terapêuticos. As plataformas de células T…
Produtos Biofarmacêuticos: Aspectos CMC
Modo de Entrega: Webinar Produtos Biofarmacêuticos: Webinar de Treinamento sobre Aspectos CMC Visão geral Este webinar é uma gravação do novo curso de instrutor, que é um curso de nível avançado sobre aspectos de Química, Fabricação e Controle (CMC) do desenvolvimento biofarmacêutico. O objetivo deste curso é fornecer uma compreensão avançada dos aspectos CMC de biofármacos desde o desenvolvimento até a comercialização. O que você vai aprender Visão geral do desenvolvimento biofarmacêutico Qualidade por Design (Quality by Design – QbD) Linhagem Celular e Desenvolvimento a Montante (Upstream)…
GMP Fundamentals: Production & Process Controls
This course offers an overview of Good Manufacturing Practices (GMP) for medical product production and process control. You will learn about GMP compliance, product design and development, process validation, control systems, and quality control procedures. Regulatory requirements, including FDA and international standards, will be covered. Upon completion, you will understand the fundamental principles and practices of GMP in medical product production. Interactive Course: What to Expect CEUs are provided once you achieve an 80% passing grade and complete the evaluation. Buy Now Return to…