Industry Insights
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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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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.
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China’s Rising Role On The Global Stage In The Oncology Market
4/23/2024
The oncology pharma market has largely been dominated by European and U.S. companies. With the ongoing expansion of the Chinese biopharma sector, innovative oncology drugs will emerge from China and compete on the international market.
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GMP Plant Uniform Lockers And Procedures: Best Practices
4/22/2024
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.