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).
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Pharmaceutical Engineering Magazine Articles
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In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software…
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The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical…
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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…
A Patient-Centric Review of ICH Q6A and ICH6B
The ICH Quality Discussion Group (QDG) has recommended contemporizing the specification setting…
Considerations for a Decentralized Manufacturing Paradigm
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An Evaluation of Postapproval CMC Change Timelines
As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is…
Continuous Manufacturing of Small Molecule Drug Substances
The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because…
Air Change Rate Reduction during Operation: Success at Roche/Genentech
To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside…
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The pharmaceutical industry began applying the principles of continuous processing to the…
Webinars Related to Advanced Manufacturing
iSpeak Blog Posts Related to Advanced Manufacturing
Training Courses Related to Advanced Manufacturing
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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