Industry Insights
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25 Years Of VST Therapies: The Journey Behind The Technology And Innovation
10/19/2021
This article explains the major stepping stones to preventing and treating serious viral infections in high-risk populations with T cell deficiencies.
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Gene Therapy that Directly Targets The Putamen Results In Favorable And Sustained Improvements in Patients With Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency
10/18/2021
In AADC deficiency, dopamine is not produced in the part of the brain called the putamen, which is, therefore, a prime target for gene therapy.
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New Plug-And-Play Guidances: Computerized Systems Validation And Audit Trail Requirements
10/18/2021
A plug-and-play approach can significantly impact how we design, build, and operate biopharmaceutical facilities. Yet, with such a new and innovative development, there are many challenges for industry to adopt the approach. This article summarizes two recently released BioPhorum standards:_ Plug-And-Play Computerized Systems Validation Strategy_ and _Plug-And-Play Audit Trail Requirements_.
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The Essential Components Of A Sterility Assurance Program
10/15/2021
The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components for a holistic sterility assurance program needed for an aseptic manufactured product.
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Challenges In Analytical Development And Testing For Gene Therapies
10/13/2021
Given the rapid emergence of gene therapies based on recombinant adeno-associated virus (rAAV), there is a great need for appropriate analytical tools to support every lifecycle stage of these products.
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An Introduction To Biopharma Facility Design & Layout
10/11/2021
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
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The Impact Of Market Restrictions On The U.S. Stem Cell Biomaterials Market
10/11/2021
Biomaterials are biomedical materials that can be safely implanted or injected into the body and are, more often than not, a form of biologically active tissue themselves. This article examines stem cell research and the market of cell-based products for orthopedic biomaterials.
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Is A SPAC The Right Option For Your Emerging Biotech?
10/1/2021
As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
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Forging A New Path Forward in Manufacturing Genetic Medicines
9/30/2021
While the past decade’s focus on scientific advances has accelerated the advancement of genetic medicines, including gene and cell therapies, manufacturing is vital to product quality, safety, efficacy and clinical trial and commercial supply. In the case of adeno-associated virus (AAV)-based gene therapy and gene editing product development, manufacturing is no simple task. As the industry advances these genetic medicines, manufacturing is also ramping up, and with it optimization and efficiencies of scale. Since the industry is still maturing, and manufacturing know-how is often kept proprietary, companies must learn, adapt, and master novel innovations as well as challenges on their own.
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FMEA Vs. System Risk Structures (SRS): Which Is More Useful?
9/24/2021
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?