Our Expert Network
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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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A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
4/19/2024
Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
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Unpacking The Importance Of Lipid Nanoparticle Production Platforms
4/15/2024
Batch processing platforms for LNPs lack efficiency, appropriate controls, and yield optimization. Continuous manufacturing platforms may address some of those issues.
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A Promising Approach To Develop An Inhalable, Temperature-Stable COVID-19 Vaccine
4/12/2024
There are limitations to the currently available COVID-19 vaccines. An inhalable dry powder approach offers promising benefits, such as eliminating cold chain requirements, allowing for more widespread immunity.
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
4/8/2024
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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When Does GMP Matter In Non-GMP Settings?
4/5/2024
Would you ever need to follow GMP standards in workspaces where GMP is not required or possible? This article digs into why, when, and how to follow the principles of GMP.
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Fine-tuning Analytical Development Strategies For Every Phase
3/22/2024
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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Navigating Grades And Sources Of Materials In Drug Manufacturing
3/22/2024
From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.