Advanced Manufacturing

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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Considerations for a Decentralized Manufacturing Paradigm
An Evaluation of Postapproval CMC Change Timelines
 |  PE Articles
An Evaluation of Postapproval CMC Change Timelines
EU MDR: What’s New and What's Challenging?
 |  PE Articles
EU MDR: What’s New and What's Challenging?
Cloud-Based Pharma
Engineering of a Pharmaceutical Project
 |  PE Articles
Engineering of a Pharmaceutical Project
Continuous Manufacturing of Small Molecule Drug Substances
Guidance Documents
SIRI framework Pros
Figure 1: Electricity consumption at Genentech California sites.
A Comprehensive Reference for Continuous Manufacturing of OSD
USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics

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Pharmaceutical Engineering Magazine Articles

Considerations for a Decentralized Manufacturing Paradigm
Considerations for a Decentralized Manufacturing Paradigm
The biopharmaceutical industry must develop and implement innovative ways of working to be effective…
An Evaluation of Postapproval CMC Change Timelines
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
Continuous Manufacturing of Small Molecule Drug Substances
The adoption of continuous manufacturing (CM) in the pharmaceutical industry is increasing because…
Figure 1: Electricity consumption at Genentech California sites.
Air Change Rate Reduction during Operation: Success at Roche/Genentech
To improve the energy efficiency of cleanrooms, the Roche Global Engineering and Oceanside…
A Comprehensive Reference for Continuous Manufacturing of OSD
ISPE Briefs: A Comprehensive Reference for Continuous Manufacturing of OSD
The pharmaceutical industry began applying the principles of continuous processing to the…
USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics
USP/BIOPHORUM Workshop on Continuous Manufacturing of Biologics
In the interest of understanding the current state of continuous manufacturing for biologics and to…
A Systemwide Approach to Managing the Risks of Continuous Manufacturing
A Systemwide Approach to Managing the Risks of Continuous Manufacturing
Understanding and managing risks to continuous manufacturing (CM) technology is central to any…
ICH Q13 and What Is Next for Continuous Manufacturing
ICH Q13 and What Is Next for Continuous Manufacturing
The creation of a new ICH guidance document, Q13,International Council for Harmonisation of…
Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing
Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing
Continuous manufacturing (CM) challenged regulators’ expectations and regulatory frameworks. This…
Enhanced Intervention Detection in Aseptic Fill Using AI/ML
Enhanced Intervention Detection in Aseptic Fill Using AI/ML
We will show how continuous, real-time capturing of data with immediate data analysis by an ML…
The Road to Explainable AI in GXP-Regulated Areas
The Road to Explainable AI in GXP-Regulated Areas
Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with…
2022 ISPE Biotechnology Conference: Ongoing Growth & Development
2022 ISPE Biotechnology Conference: Ongoing Growth & Development
More than 400 attendees learned about the latest developments in biopharmaceuticals, cell and gene…