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
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…
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…
PE Articles
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…
iSpeak Blog
When Analytics Meet Quality
Intersection of Analytical Techniques and Quality Management In today’s data-driven world, the…
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
Jul 15, 2025
Manufacturing Operations
Oral Solid Dosage
Jul 08, 2025
Information Systems
Artificial Intelligence
Data Integrity
Jul 08, 2025
Pharma 4.0™
Jun 20, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Jun 19, 2025
Quality
Lifecycle Management
Validation
May 22, 2025
Webinars
ISPE in the News
Latest
-
Search and Post Jobs at ISPE’s Career Center
-
Regulatory Innovation and Global Collaboration highlighted at the ISPE Europe Annual Conference
-
Partnership Aims to Automate Cell Therapy Manufacturing
-
FDA Posts 200 Complete Response Letters
-
Playbook Helps Prepare for Unannounced Inspections
-
How Data Can Prevent Supply Chain Failures
-
Arkema to Expand Polyamide Production in Singapore
-
Nigeria Aims to Grow Pharma Industry to $10B
-
Myrtelle Begins Manufacturing for Gene Therapy
- Advanced Manufacturing Can Give Edge to US Pharma
iSpeak Blog Posts
Pharmaceutical Job Board
Pharmaceutical Engineering Magazine Articles
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…
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…
Videos
Professional Development Training
ICH Q7: API Guidelines
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
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. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…
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. CEUs are provided once…
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)…