Andelyn Biosciences’ Post

Hope you can make this webinar as AI continually speeds the process of innovation and it is more crucial then ever to be compliant and audit ready!!!!

Rich insights from Industry Giants - Rob Schulz and James Wabby. Take a moment to listen, truly worthwhile. Regulatory intelligence must consider cultural norms and political climate to drive a successful regulatory submission strategy. Find out how.

In mRNA drug production, controlling dsRNA residuals is crucial for ensuring safety and efficacy. At YXgene, we offer advanced processes that precisely manage dsRNA levels, providing reliable technical support for your projects. ✅ Standard Preparation: dsRNA residuals to <0.1% ✅ Specialized Preparation: dsRNA residuals to <0.01% 💡 We offer a range of IVT processes tailored to your specific production needs, ensuring every step meets your exact standards. Choose YXgene for high-quality, precision mRNA manufacturing. Together, let's advance the future of gene therapy. 🔗 Learn more about our manufacturing processes and technology. #mRNA #GeneTherapy #dsRNA #Biotechnology #YXgene

Last chance to register | Expert Roundtable: Streamlining Cell and Gene Therapy Scalability With 2024 CGT approvals by the FDA anticipated to reach double figures, now more than ever it is critical to consider the end product from the earliest stages of development. We’re uniting an esteemed panel from AAVantgarde Bio, Axovia Therapeutics, Gamma Biosciences, and Nanoscope Therapeutics Inc. to uncover: - Key differences between material requirements for research vs. GMP vectors - The importance of standardizing materials and manufacturing processes - Real-world examples of how the pathway to the clinic can be streamlined Join us on May 13: https://okt.to/plBhUF James Cody Phil Vanek Samarendra Mohanty Victor Hernandez #viralvectors #genetherapy #roundtablewebinar #humangenetherapy

The biotech industry is evolving at rapid speed, and staying ahead demands a proactive approach. In this on-demand webinar, our CTO, Hanna P. Lesch, along with industry experts share their practical insights to help you navigate the challenges and seize opportunities in cell and gene therapy. By watching, you'll learn: 🔍 Key strategies to secure vital funding in a competitive market 🏆 How to refine your operations while maintaining top-notch quality and regulatory compliance 🌐 How to overcome hurdles to get your therapies approved and into the market 💰 Tips for mastering the complexities of pricing to ensure your therapies reach patients and remain profitable Watch on-demand below. https://lnkd.in/e7a-zrZx #GeneTherapy #CGT

Biocom California recently invited Sapient to contribute an article for its Lifelines Magazine edition focused on innovations in #genetherapy and #celltherapy. https://bit.ly/3V6gqd4 While cell- and gene-based treatments are advancing rapidly, spurred by a landmark year of FDA approvals, their development is not without challenges. We discuss how #multiomics for gene and cell therapy can deliver the novel insights needed to realize the incredible therapeutic potential represented in these pipelines today: https://bit.ly/3V6gqd4

Register for a free webinar on "Navigating the New Era of Asset Maintenance Management: A Gene Therapy Company's Transformation". https://lnkd.in/gHFh-dG8 . Attendees will learn how 4D Molecular Therapeutics overhauled their manual maintenance-related processes throughout their facility, unveiling a plethora of improvement opportunities. Dave Porrill from Blue Mountain and Wes Champion from PCI will discuss 4DMT’s journey of implementing a validated Computerized Maintenance Management System (CMMS) and the tangible benefits they reaped. It not only brought about better alignment and structure to their processes, but it also revolutionized their maintenance workflow. Register here to attend: https://lnkd.in/gHFh-dG8 . #BlueMountainRAM #GMPDigitalMaturtityModel #RegulatoryAssetManager #AdvanceGMPcompliance

Exciting webinar alert! Discover how 4D Molecular Therapeutics upgraded their maintenance processes with a validated CMMS. Hope to see you there for insightful discussions with industry leaders Dave Porrill and Wes Champion!

Learn how to integrate an analytical development strategy into your CMC plan and set your Cell & Gene Therapy projects up for success! 🚀 Join our upcoming webinar for expert insights and case studies. 🔗 https://buff.ly/4es7tS4 #GeneTherapy #CellTherapy #Pharma #BioTech

To close the week, we would like to remind you of the final slide deck/presentation created by experts within BioPhorum Advanced Therapy Medicinal Products on validation challenges and method validation controls. You can download the slide deck/presentation here: https://lnkd.in/e6HKtXT8 This method validation controls content reviews the regulatory challenges faced in cell and gene therapy with a focus on identifying and using appropriate analytical controls when dealing with both limited regulatory guidance and limited materials - thus providing possible options to avoid potential issues and accelerate the validation process. The content focuses on challenges such as appropriate controls and standards, alternative materials when resources are scarce, and the relevance of reference standards when processes change. To view BioPhorum Advanced Therapy Medicinal Products’ full portfolio of publications visit: https://lnkd.in/exqf9Khu #ATMP #celltherapy #genetherapy #validation