Industry Insights
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Process Analytical Technology: Meeting The FDA’s Aspirational Guidance In Continuous Manufacturing
7/9/2018
In 2004, the FDA published an aspirational guidance for industry on process analytical technology. This article describes examples where industry has succeeded in meeting the FDA guidance.
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The Role Of CRISPR Cas9 Plasmids In Gene-Editing
12/12/2023
Plasmids are crucial for CRISPR-Cas9 gene-editing technology, and their role in CRISPR is expected to evolve with ongoing research.
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Combat Major Cell And Gene Therapy Manufacturing Regulatory Obstacles
8/8/2023
As cell and gene therapies grow in the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.
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ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments
2/22/2024
Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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4 Key Considerations When Engaging A New GMP Contract Service Provider
4/12/2017
This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing.
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System Risk Structures: A New Framework For Avoiding Disaster
7/13/2020
Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.
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How To Evaluate & Manage Safety Risks In Biopharma
5/2/2022
Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).
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Detection And Quantification Of Process-Related Impurities
6/1/2023
Finding a partner with the expertise and capabilities to provide solutions for detecting and quantifying process-related impurities ensures the successful development and manufacturing of safe and effective products.
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U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use
1/18/2017
The U.S. Department of Defense recently opened the Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility — the first dedicated advanced manufacturing facility capable of developing and making biological (and small-molecule) products to protect service members who may be exposed to biological weapons or natural threats.
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Is The U.S. Ready For A Re-shored Pharma Supply Chain?
7/2/2020
In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.