Advanced Manufacturing (Adv Manuf) is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. Examples of some cross-cutting advanced manufacturing technologies include continuous manufacturing and additive manufacturing (e.g., 3D printing).
PE Articles
Formulation Challenges in Lyophilized Products
Formulation challenges in pharmaceuticals are increasing in complexity due to the rise of…
PE Articles
Volunteer Profile: Krisha Patel, ATMP Community of Practice Co-Chair
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and…
PE Articles
Continuous Viral Vector Manufacturing
A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene…
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…
PE Articles
Message from the Chair: ISPE Guides and Resources on Biopharma, ATMPs, and C>
Biopharmaceuticals continue to proliferate in the pharmaceutical industry leading to advancements in…
iSpeak Blog
Approaches to Lifecycle Management and Regulatory Readiness in Advanced Therapies
At the 2024 ISPE Annual Meeting & Expo, a session focused on lifecycle management considerations for…
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…
iSpeak Blog
Exploring the Future of ATMP Manufacturing from Digitalization to Navigating Regulations
In an era where advanced therapy medicinal products (ATMPs) are revolutionizing healthcare, the 2024…
Guidance Documents
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Lifecycle Management (1)
Manufacturing Operations (2)
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Pharmaceutical Engineering Magazine Articles
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…
Final Preparation of ATMPs at Point of Care
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products…
The Role of AI and ML in Efficiency and Innovation
The integration of artificial intelligence (AI) and machine learning (ML) into bioprocess…
Artificial Intelligence in Drug Target Discovery
The intersection of AI and drug development has ushered in a transformative era, revolutionizing the…
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
Gene Editing and Facility Retrofits for CRISPR and Beyond
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies…
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…
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…
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
A Sustainable Approach to Steam Quality Management
The world is beginning to grasp the huge challenge of achieving net-zero carbon emissions, or carbon…
iSpeak Blog Posts
Professional Development Training
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
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…
Biopharmaceuticals: C> and ATMP
Biopharmaceuticals: C> and ATMP Training Course Overview This new instructor lead course is an advanced level course on Cell and Gene Therapies C> and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C> products (e.g. plasmids, mRNA, lipid nanoparticles, viral vectors), covering terminology, manufacturing processes and subsequent analytical characterization of the manufactured components and therapeutic products. The adeno-associated virus (AAV) and chimeric antigen receptor (CAR) T-cell…
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