Industry Insights
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Evaluating, Validating, And Implementing NAT-Based Mycoplasma Detection Methods
5/3/2024
Regulatory authorities advocate using alternative adventitious agent tests, but adoption has been slow. Here’s how to validate an alternative mycoplasma detection assay.
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New Initiative Seeks To Back Up ICH's Harmonization Mission
5/3/2024
An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.
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Forum Notebook: Quick Takes From USP’s mRNA Virtual Summit
5/1/2024
The United States Pharmacopeia held a forum in February to exchange ideas about analytical methodologies and release testing. Here's a recap of the event.
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Assessing pDNA Purity For Cell & Gene Therapies
5/1/2024
Plasmid DNA (pDNA) is used in gene therapies, vaccines, and RNA therapeutics. Along each step of development, we need to evaluate potential impurities.
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mRNA: The Fourth Pillar Of Pharmaceutical Innovation And Intervention
4/26/2024
mRNA medicines represent the genesis of a fourth pillar of pharma innovation. While exciting, there are several critical challenges we must solve to strengthen this pillar, including stability and deliverability.
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Advancing PSC-Based Therapies: The Application Of Non-Integrating Engineering Strategies To Improve Directed Differentiation
4/25/2024
This article explains why the incorporation of non-integrating, traceless engineering tools in PSC directed differentiation approaches could significantly help streamline the development of allogeneic cell therapies.
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Integrating Quality Processes And Documentation After A Merger
4/25/2024
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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Inside BlueRock Therapeutics' Parkinson's Disease Trial with Dr. Ahmed Enayetallah
4/25/2024
BlueRock Therapeutics' SVP Head of Development, Dr. Ahmed Enayetallah, joins Cell & Gene: The Podcast Host, Erin Harris, to discuss the company's phase I clinical trial for Parkinson’s disease, which continues to show positive trends at 18 months.
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NK Cell Therapies: How Artiva Biotherapeutics Leverages Its “Manufacturing First” Approach
4/24/2024
We caught up with Chris Horan, Artiva Biotherapeutics' CTO, to discuss natural killer cell therapies and Artiva’s experiences and strategies with its candidate, AlloNK.
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Improving Governance And Compliance With Knowledge Management
4/23/2024
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.