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| Working on mRNA analytics, assay development, or quality control? Join 100 of your peers in Boston this February for the 4th mRNA Analytical Development & Quality Control Summit for 3 days of industry insights and networking to support your therapeutic and vaccine approvals. Confirmed speakers include the FDA, BioNTech, Moderna, Zipcode Bio, Orna Therapeutics and more! See the program here. |
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By AR Welch, Editorial & Community Director, Advancing RNA | During our hour-long conversation, Sagaert and I covered a lot of ground on the current state of the industry. But given his background in quality, it shouldn’t come as a surprise that our conversation ultimately gravitated back to some of the biggest questions we currently have and need to answer about our product’s structure and function — and how to adequately demonstrate this critical knowledge to regulators. |
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This segment features a discussion around the obstacles to establishing a standardized production pipeline for mRNA therapeutics across the industry as well as some the approaches being considered to standardize cold chain management protocols for mRNA products. |
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By BioPhorum | This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities. |
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| Methods For mRNA Poly(A) Sizing | Poster | By L. Hinkel, R. Williams, C. Herren, and T. Legan, Vernal Biosciences | This study used Oxford Nanopore Technologies' Direct RNA Sequencing Kit and obtained successful sizing of poly(A) tail regions. The results are presented in a histogram and table format. |
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| Improving Toxicology Testing For Inhalation Products | Article | Battelle | By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs. |
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