Featured Pharma Online Editorial
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How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development
12/22/2021
Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. Here's how AstraZeneca did it.
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The 4 Ways AI Implementation Is Changing The Future Of Precision Medicine
12/10/2021
Part 1 of this two-part series examined how recent advances in for oncology diagnosis and treatment preview the full potential of precision medicine. This article, Part 2, shares insights on the 4 challenges the industry must overcome before individualized healthcare can be fully realized.
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Model-Based Control In Continuous Biomanufacturing
11/24/2021
In comparison to batch manufacturing, continuous manufacturing offers shorter development time, improved product quality, lower capital cost, and easy scale-up. The primary focus lies on establishing a flexible and standard platform with real-time monitoring, automated start-up/shut down, and a control strategy to address dynamic conditions.
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Two Emerging Fields Propelling AI In Precision Medicine
11/22/2021
Advances in AI-based analysis paradigms have created an unprecedented momentum in computational medical imaging applications, giving rise to new areas of precision medicine research. This article examines how recent medical imaging advances in oncology are bringing about new areas of precision medicine and previews its full potential.
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Juno v. Kite: Implications For Functionally Claimed Biologics
11/12/2021
The Federal Circuit recently reversed a jury verdict in the case Juno Therapeutics, Inc. v. Kite Pharma, Inc.., wiping out a $1.2 billion judgment for Juno in the lower court by invalidating claims directed to the functional properties of biological compounds that could be used as therapies. What does this mean for biologics developers going forward?
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Model-Based Control In Continuous Manufacturing of Biotherapeutics
11/10/2021
During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.
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Opportunities For Implantable Drug Delivery To Modernize Drug Therapy
11/8/2021
The implantable drug delivery system allows targeted and localized drug delivery for achieving an optimum therapeutic effect. This article examines the clinical significance of implantable drug delivery systems as well as opportunities that can be leveraged by drug therapy developers in meeting global health needs, particularly in the areas of women's health, cancer treatment, and ocular disease treatment.
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How To Mitigate The Risks Posed By "High-Risk" Host Cell Proteins
11/3/2021
Host cell proteins are processārelated impurities that may copurify with biopharma drug products. Some of these can be considered high-risk, including those that are immunogenic, biologically active, or enzymatically active with the potential to degrade molecules or excipients used in formulation. Here's how to mitigate those risks.
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Where Is Technological Innovation Needed For CAR-T Manufacturing?
10/29/2021
Investment in cell therapy biomanufacturing has continued to follow a steady upward trend. Even with the anticipated increases in capacity, there are still concerns facing current and future cell therapy manufacturing capacities, including an anticipated “capacity crunch.” This article examines where technological innovation is needed to avoid this capacity crunch.
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The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials
10/25/2021
While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques.