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Rewriting The Health Code How mRNA Technology Is Shaping The …

WebBy Stefan Randl and Maaike Everts, Evonik Health Care. The Covid-19 pandemic has ushered in a new era in medicine – that of mRNA technology. But the …

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URL: https://www.bioprocessonline.com/doc/rewriting-the-health-code-how-mrna-technology-is-shaping-the-future-of-medicine-0001

A Regulator Looks Back On What We Learned From Accelerated …

WebBy February 2022, five more SARS-CoV-2 neutralizing mAb products were authorized for emergency use (EUA 91, EUA 94, EUA 100, EUA 104, and EUA 111) 1. …

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Clinical Data Launches PGxHEALTH And COGENICS

WebThe PGxHEALTH and COGENICS divisions collectively position Clinical Data among the largest, independent providers of pharmacogenomics and clinical diagnostics …

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Surge Manufacturing For Biopharma Resilience

WebSurge Manufacturing For Biopharma Resilience. Source: Cytiva. Kayla Hannon was in the trenches at Moderna when the company faced a once-in-a-century …

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Merck CEO Announces Structure And Global Leadership Team For …

WebRichard T. Clark, chairman, president and chief executive officer of Merck & Co., Inc. recently announced a new organizational structure and named top management …

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Essential Elements Of Technology Transfer

WebA comprehensive list of in-process and proposed product release methods is another essential element of the technology transfer package. This list is used by the RU …

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Choosing The Best Regulatory Pathway For Microbiome Products

WebAOBiome is driving live biotherapeutic treatments for skincare with ongoing Phase 2 trials for eczema and rosacea and a planned Phase 3 trial for acne. While the …

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Population-Level Health Impact With Vaxxinitys John Krayacich

WebPopulation-Level Health Impact With Vaxxinity's John Krayacich. Vaxxinity’s John Krayacich likes taking big swings and big indications. He’s played key roles on the teams that …

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Protecting Human Health With Organ-On-A-Chip Technology

WebProtecting Human Health With Organ-On-A-Chip Technology. At the onset, symptoms manifest subtly with just a sense of nausea, but soon give way to abdominal …

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Applied Biosystems Expands Sequencing-Based RNA Analysis …

WebSOLiD™ Whole Transcriptome Expression Kit Provides Comprehensive, Specific Analysis of All Known RNAs Present in Biological Samples. FOSTER CITY, …

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Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations

WebIn the biopharma industry, “human error” is often selected to describe a deviation for which the immediate apparent cause was the behavior, which could be …

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4 Key Takeaways For Combination Products As We Move Into 2023

WebI delve into the summit’s four key takeaways below. 1. Recent & Upcoming Activities Shared By The Office of Combination Products. The main summit session …

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US Congress Passes Bill Supporting New Era of Biopharma …

WebOn Oct. 19, 2021, the House passed H.R. 4369. The bill authorizes $100 million over four years to establish National Centers of Excellence in Advanced and …

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Catalent Announces Partnership With Toyobo Biologics, Inc. To Co

WebCatalent Pharma Solutions, a leading provider of drug and biologic development services, delivery technologies and supply solutions, and Toyobo Biologics, …

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FDA Releases Guidance On CMC Changes To An Approved …

WebThe FDA has issued a new guidance to help applicants and manufacturers of certain licensed biological products to determine the type and scope of changes to their …

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BeiGene FDA ACPHS Announce Pharmacovigilance Fellowship

WebRather than seek employment as a community pharmacist, Dr. Wagner leaned into her own Fellowship at the FDA and took a post there after graduating …

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Mapping The Biosimilar Regulatory Landscape In The Middle East

WebThe biosimilar market in that region is expected to surge ahead at a compound annual growth rate of nearly 4% and reach $623.7 million by 2027, according to an …

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Cleanroom Gowning Compliant With EU GMP Annex 1 An Overview

WebAnnex 1 (2022), Manufacture of Sterile Medicinal Products, produced by the European Commission EudraLex, is the most descriptive guidance on cleanroom gowning. Annex 1 …

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Understanding And Navigating Diverse Regulatory Environments

WebThe diversity of regulatory standards originates from differences in healthcare systems, cultural nuances, and socioeconomic variables. Navigating a myriad …

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"Human Error" Deviations: How You Can Stop Creating (Most Of) …

Web<p>In the time it takes you to read this article, the industry will generate (conservatively) about 115 new process deviations, and about 65 of them will be …

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