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
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…
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
Unlock Your Potential: Become an Active ISPE Team Player
What does it mean to be a “team member?” What ideas come to mind in your favorite sport where you…
PE Articles
Seamless Integration: ZETA's Approach to Single-Use Systems
Since 2011, ZETA has been delivering customized single-use systems such as bioreactors…
Video
2025 ISPE Annual Meeting & Expo - What to Expect
Discover why the 2025 ISPE Annual Meeting & Expo is a can't-miss event. Find opportunities to…
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
Mar 14, 2025
Data Integrity
Mar 14, 2025
Advanced Manufacturing
Critical Utilities
Feb 16, 2025
Workforce of the Future
Feb 15, 2025
Manufacturing Operations
Feb 13, 2025
Manufacturing Operations
Oral Solid Dosage
Feb 10, 2025
Sustainable Facilities, HVAC, & Controlled Environments
Feb 06, 2025
ISPE in the News
Latest
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Discover Exciting Career Opportunities on the ISPE Career Center
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ISPE Training: GMP Fundamentals: Eleven-Part Bundle Series, On Demand
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EMA Outlines Drug Shortage Monitoring Data Access Policy
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Mallinckrodt, Endo Announce Merger
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Private Equity Firms Eye Purchase of Gerresheimer
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EU Proposes Steps to Increase Domestic Pharma Production
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CDMO Receives GMP Certification for Orphan Drug Fill-Finish Services
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Almac Opens Manufacturing Facility in Northern Ireland
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Integration of AI, IoT Bridges Digital, Physical Worlds
- Pitfalls in Medtech Development, and How to Avoid Them
iSpeak Blog Posts
Pharmaceutical Job Board
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…
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…
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…
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…
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)…