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This article by Clinical Excellence GmbH's Jessica Cordes breaks down why high-quality Good Clinical Practice (#GCP) training is a must for investigators and staff involved in #CGT #clinicaltrials. She offers suggestions for developing a GCP training strategy and why trainee certification is a crucial part of the process. #cellandgenetherapy https://lnkd.in/eAZQNTtS
Sterility Assurance: The Fundamentals https://lnkd.in/eRWEBAam - By Yadnyesh Patel, microbiology subject matter expert This article series outlines the key components of sterility assurance, including the validation of sterilization processes, environmental monitoring, and stringent quality control measures.
The Latest Strategies For Quantifying AAV Capsid Titer https://lnkd.in/ev5xj5p8 - By Marília Barros, Ph.D., Regeneron Accurate quantification of capsid titers is essential for determining appropriate dosing regimens, as the total capsid count impacts both the efficacy and safety of the therapy.
Computer Systems Validation Pitfalls, Part 1: Methodology Violations https://lnkd.in/e8eS3U3V - By Allan Marinelli and Abhijit Menon A lack of QA leadership management/technical experience can result in pharmaceutical, medical device, cell & gene therapy, and vaccine companies losing profits, efficiencies, and effectiveness.
Don’t miss the next Cell & Gene Live digital event on October 29th! https://lnkd.in/evarZusd The field of non-viral genetic engineering is advancing quickly, with exciting research focused on enhancing transfection efficiency, precision targeting, and the safety of delivery systems. Host Erin Harris welcomes Celularity Inc.’s Robert Hariri, MD, PhD and Beam Therapeutics’ Paul Kopesky. Registration is free thanks to the support of MaxCyte, Inc.
How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside https://lnkd.in/eaxb-fqf A conversation with Aki Ko, CEO, Elixirgen Therapeutics, Inc. Therapeutics
Join us! In this 💥 final Advancing RNA Live discussion of 2024, we sit down with three LNP experts to parse out the current opportunities and unknowns facing the 🔬development of next-generation LNPs. Registration is free thanks to the support of Helix Biotech, Inc. Our host Anna Rose Welch and industry experts will tackle unique LNP manufacturing hurdles, and unpack what's in the immediate future for RNA-LNP R&D and CMC. 🔗 Reserve Your Spot: https://lnkd.in/eKT_xKPj 📅 Wednesday, November 06, 2024 🕙 10:00 AM EDT | 1 HR #rna #lnp #cmc #RNAtherapeutics
Don’t miss the next Cell & Gene Live digital event on October 29th! https://lnkd.in/edE4yp6j The field of non-viral genetic engineering is advancing quickly, with exciting research focused on enhancing transfection efficiency, precision targeting, and the safety of delivery systems. Host Erin Harris welcomes Celularity Inc.’s Robert Hariri, MD, PhD and Beam Therapeutics’ Paul Kopesky. Registration is free thanks to the support of MaxCyte, Inc.
Cell & Gene Therapy In The Asia Pacific Clinical Trial Landscape https://lnkd.in/eFgcSBxG - Source: Novotech Treatment is expensive, and clinical research assessing safety and effectiveness are primarily carried out in high-income countries.
In this edition of Cell & Gene "In Focus": TRENDING CONTENT - Catch Up #1. The Future Of Autologous CAR-T Manufacturing: Balancing Innovation With Improvement #2. How To Leverage Platform And Process Characterization Data To Accelerate Cell & Gene Therapies #3. Mammoth Biosciences On Epigenetic Editing #4. 4 Strategies For Modernizing The Manufacturing Quality Control Lab #5. Tips For Viral Vector Production #6. Adeno-Associated Virus: Enabling Genomic Medicine
