Drug Discovery & Development’s Post

Thoughts on this? >> White Paper: Navigating the regulatory path of CRISPR-based therapeutics 13 May 2024 - SelectScience >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #pharmaceutical #biotech #competitivemarketing

Thoughts on this? >> White Paper: Navigating the regulatory path of CRISPR-based therapeutics 13 May 2024 - SelectScience >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #healthcare #competitivemarketing #pharmaceutical

Did you know there are more than 800 ongoing clinical trials using CAR-T technology in the United States alone? This means new treatments and cures could be on the horizon for millions of patients.   And all of this could come faster due to recent innovations through plasmid DNA that are improving the efficiency of CAR-T development and manufacturing and providing increased safety profiles of end products.   Aldevron is proud to be a leader in #plasmidDNA, with a team of experts ready to support our clients as they move new therapies from the research stage to final products. Read more from Venkata Shravan K Indurthi on the promise of plasmid DNA in a recent publication from @European Pharmaceutical Manufacturing (page 8)! https://lnkd.in/gfZyaJwB

Did you know there are more than 800 ongoing clinical trials using CAR-T technology in the United States alone? This means new treatments and cures could be on the horizon for millions of patients.     And all of this could come faster due to recent innovations through plasmid DNA that are improving the efficiency of CAR-T development and manufacturing and providing increased safety profiles of end products.     Aldevron is proud to be a leader in #plasmidDNA, with a team of experts ready to support our clients as they move new therapies from the research stage to final products. Read more from Venkata Shravan K Indurthi on the promise of plasmid DNA in a recent publication from @European Pharmaceutical Manufacturing (page 8)! https://lnkd.in/ght9pH6R

Thoughts on this? >> FDA official tells CGT developers to leverage multiple meeting opportunities with agency - Regulatory Focus >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #competitivemarketing #pharma #pharmaceutical

Thoughts on this? >> FDA official tells CGT developers to leverage multiple meeting opportunities with agency - Regulatory Focus >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #biotech #competitivemarketing #pharmaceutical

🔊 Last chance to register! Join our next live webinar tomorrow and gain novel insights into #surfactant characterization methods and #polysorbate degradation mechanisms. 👉 Register here: https://lnkd.in/dbXAaZyz #CoriolisPharma #surfactantcharacterization #polysorbates #poloxamers

🌟 Speaker Spotlight: Dr. Andrey Sarafanov 🌟 Join us at the Extractables & Leachables Summit West 2024 as we welcome Dr. Andrey Sarafanov, Principal Investigator at the US FDA Center for Biologics Evaluation and Research. Dr. Sarafanov will present on "Analytical Assessment of Leachables in Biological Drug Products: FDA Approach and Experience in Reviewing Information." Biological drug products, including therapeutic proteins and gene therapies, undergo complex manufacturing processes involving various materials that can leach into the final product. This poses significant challenges for assessing leachables, often leading to regulatory complexities and post-marketing commitments. Dr. Sarafanov's session will delve into the FDA's approach to evaluating leachables, addressing common pitfalls such as incomplete analytical validations and underestimation of cumulative leachables risks. His insights aim to streamline the submission and review process, ensuring robust regulatory compliance and patient safety. Don't miss this opportunity to gain valuable perspectives from a regulatory expert on navigating the intricate landscape of leachables in biologics. See you at the summit! Learn more here: https://lnkd.in/gti9QPCJ #FDA #Biologics #Leachables #RegulatoryCompliance #DrugSafety #ExtractablesLeachables

Thoughts on this? >> Taysha’s $75M offering; Augustine raises €17M >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #productmarketing #healthcare #pharmaceutical

Don't miss our next #Coriolis Webinar on the highly relevant topic of #surfactants in #biologics tomorrow!