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).
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…
PE Articles
Bioreactor Exhausting Systems are Not as Exhausting as They Sound
IPS-Integrated Project Services is a global provider of technical consulting, architecture…
PE Articles
Embracing the Unknown: QRM Strategies for Cell and Gene Therapies Facilities
The pharmaceutical landscape is rapidly evolving, and cell and gene therapies (C>) are at the…
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
The Future of ATMPs: Insights, Opportunities, and Innovations at the 2024 ISPE Annual Meeting
Globally, there is an increase in approved advanced therapy medicinal products (ATMPs), with…
Video
Connecting ATMP Discovery to Commercial: Improving Manufacturability
Connecting ATMP Discovery to Commercial: Improving Manufacturability Complimentary Learning Level…
PE Articles
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
iSpeak Blog
Practice the ISPE Good Practice Guide Series – Expert Workshops at the 2024 ISPE Annual Meeting & Expo
Building off the success of the 2023 ISPE Annual Meeting & Expo, the program committee has developed…
PE Articles
New Guides Expand ATMP Knowledge
The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide…
Video
Unique Aspects of OOS Investigations Related to Biotech Products
Unique Aspects of OOS Investigations Related to Biotech Products Complimentary Learning Level…
PE Articles
Cell Culture Media Manufacturing Controls for Bio-Manufacturing
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) represent a…
PE Articles
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…
Guidance Documents
Advanced Manufacturing (4)
Biotechnology (2)
Data Integrity (1)
Lifecycle Management (1)
Manufacturing Operations (2)
Oral Solid Dosage (1)
Pharma 4.0™ (1)
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…
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…
Computer Software Assurance and the Critical Thinking Approach
In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software…
ISPE Briefs: Introducing New ISPE Baseline® Guides
The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical…
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…
Design Considerations for Large-Scale Stem Cell Manufacturing
There is much that large-scale commercial stem cell therapy processes can adopt from the existing…
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Professional Development Training
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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