Industry Insights
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Imagine A World Without HIV – Could Gene Therapy Deliver A Cure?
12/12/2023
As our understanding of HIV molecular biology and pathogenesis has broadened, it has opened opportunities to explore gene therapy as a potential solution for delivering long-term viral suppression for patients.
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Introduction To The New ASTM E3418, Standard Practice For Calculating Scientifically Justifiable Limits Of Residues For Cleaning Of Pharmaceutical And Medical Device Manufacturing Equipment And For Medical Devices
12/11/2023
The ASTM E55 Cleaning Team has developed and balloted a new standard practice for calculating safe and scientifically justifiable limits for residues found after cleaning processes. This is the first comprehensive guide to setting limits for use in cleaning validation that includes all types of chemical residues, bioburden residues, endotoxin residues, and visual residues.
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Overcoming The Limitations Of CAR T-Cell Therapy
12/7/2023
Vittoria Biotherapeutics’ CEO shares the company's mission to expand the applications for CAR-based therapeutics by employing novel cell engineering and gene editing technologies.
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FDA Issues Draft Guidance On Remote Interactive Evaluations Of Drug Manufacturing And Bioresearch Monitoring Facilities
12/5/2023
In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
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The RNA Therapeutics Race: How Can Pharma Stay Ahead Of The Wave?
12/5/2023
With more than 970 RNA therapies currently in the development pipeline, the market presents an exciting prospect. This article shares the key attributes of RNA therapies that are paving the way for personalized medicine, novel delivery mechanisms, and more.
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Designing Facility Monitoring Systems For Cleanrooms
12/4/2023
Let's examine the features and advantages of facility monitoring systems, system architecture considerations, and overall system considerations.
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Release Testing Of AAV Gene Therapies For Clinical Trials
11/29/2023
Adeno-associated virus (AAV) gene therapies that are designed to deliver a therapeutic transgene to patients are complex products that can be challenging to manufacture. Because of their complexity, a variety of analytical methods are required to ensure that these viral vectors are of high quality and purity, will function as intended, and have batch-to-batch consistency.
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Can Aptamers In Wearable Sensors Mean A Revolution In Healthcare?
11/28/2023
For decades, biosensor researchers dreamed about having affinity biosensors that were reversible, but most of us thought this was impossible. The key to achieving this was a new class of affinity biomolecule called an aptamer, which are sequences of DNA that do not bind to other nucleic acids but rather bind to small molecules and proteins like antibodies.
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How Can Digital Twins Get Us Closer To Pharma 4.0?
11/28/2023
Digital twins — virtual representations of physical and conceptual assets, processes, or systems — offer a seamless bridge between the present challenges and the vision of Pharma 4.0.
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Your 6 Priority Areas For A Successful 2024
11/27/2023
As we approach the end of 2023, and pharma/biotech companies finesse their road maps for 2024, this article assesses the six priorities vying for attention.