Advanced Therapy Medicinal Products (ATMPs) are medicines for human use based on genes, tissues, or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.
iSpeak Blog
Advancing Precision Medicine with ADCs and Radiopharmaceuticals
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like…
PE Articles
Pharma 4.0 – Plug & Produce Architectural Principles
A set of principles to be considered in the journey to adopting and deploying an architecture…
PE Articles
Greenfield manufacturing in life sciences
In this point of view, Life Sciences greenfield builds, Capgemini’s life sciences manufacturing…
iSpeak Blog
Process Considerations When Designing mAbs Production Facilities
Designing a monoclonal antibody (mAbs) production facility presents a series of unique challenges…
PE Articles
Cell Therapy and Closed Process Manufacturing
To date, there has been a reluctance for cell therapy manufacturing facilities to move away from…
iSpeak Blog
Beyond Automation: The Human Touch in Industry 5.0
The future of manufacturing is not a battle between humans and machines. It is a collaboration that…
PE Articles
Development of an Anomaly Detection Algorithm for Predictive Maintenance in Lyophilization Systems
This paper focuses on the development of a diagnostic tool for predictive maintenance in industrial…
PE Articles
The Shift from CSV to CSA
In today's rapidly evolving pharmaceutical landscape, ensuring compliance with regulatory…
PE Articles
Navigating GxP Compliance in the Cloud: Ensuring Security, Data Integrity, and Performance
When seeking a monitoring system, you are confronted with an abundance of choice. The options are…
PE Articles
Guiding Principles for Combination Product Reliability
Drug delivery devices have become an essential component for many modern medical therapies, and it’s…
Video
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation
ISPE Pharma 4.0 Baseline Guide – Enabling Digital Business Transformation Complimentary Learning…
Video
Connecting ATMP Discovery to Commercial: Improving Manufacturability
Connecting ATMP Discovery to Commercial: Improving Manufacturability Complimentary Learning Level…
Guidance Documents
Advanced Therapy Medicinal Products (1)
Biotechnology (1)
Manufacturing Operations (1)
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Community Discussions
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine 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…
Potency Measurements for Cellular and Gene Therapy Products
Cell and gene therapy (C>) products address various diseases at the cellular or genetic level…
Repurposing a US Cell Therapy Facility for Flexibility and EU Compliance
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
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…
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…
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…
CoP Leader Profiles: Erich H. Bozenhardt
Erich H. Bozenhardt is the Associate Director of Process Engineering in Regenerative Medicine…
Comparability Considerations for Cellular & Gene Therapy Products
Cell and gene therapy (C>) products comprise a rapidly growing field of innovative medicines that…
Optimizing Cost of Goods for Cell Therapy Manufacturing
Facility design decisions made early in conceptual design can have a significant impact on the cost…
Delivering Curative Therapies: Autologous vs. Allogeneic Supply Chains
Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the…
Videos
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…
On Demand Biopharmaceutical Three-Part Bundle Series
$775 Savings by Purchasing All Three Courses Overview ISPE is presenting a three-part series that will focus on an introduction to Large Molecules and the Chemistry, Manufacturing, and Controls (CMC) aspects of biopharmaceutical development with an emphasis on how they differ from traditional small molecule pharmaceutical development. The bundle also 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…
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…
Biopharmaceuticals: C> and ATMP
This 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 platforms are presented as the two most common and established…
ATMP Manufacturing
This course is focused on the commercial manufacture of Advanced Therapy Medicinal Products (ATMPs) drug products in manufacturing facilities. The purpose of this course is to focus on facility engineering issues and how to provide cost-effective facilities to ensure that products of the highest quality are consistently manufactured, as defined in the new Good Practice Guide.
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