Carolyn Yong’s Post

The FDA is currently seeking public feedback until July 30th on the draft guidance document titled "Considerations for the Use of Human and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products." This guidance aims to provide recommendations for the use of materials derived from human and animal cells in the manufacturing of cell and gene therapy (CGT) products and tissue-engineered medical products (TEMPs). The document specifically addresses considerations for the inclusion of cell-derived materials, such as #extracellularvesicles, including #exosomes (called 'cell-derived particles' in the document). These components are critical in the manufacturing process as they can influence the safety and efficacy of the final therapeutic products. The guidance seeks to ensure that such materials meet regulatory standards for quality and safety, and it outlines the necessary steps for risk assessment and mitigation strategies in the use of these biological materials. #FDA #CellTherapy #Biologics #Biotechnology #RegulatoryAffairs #Biopharma #MedicalDevices #HealthcareInnovation #ClinicalTrials #PublicHealth #exosomes #extracellularvesicles #lifescience

🚀 New #FDA Draft #Guidance for Cellular & Gene Therapy Development - open to submit comments📚 Are you navigating the complexities of developing cellular and gene therapy (#CGT) products? The FDA’s latest draft guidance is here to help! This document answers frequently asked questions (FAQs) and addresses common challenges in CGT development across multiple areas, including: ✅ Regulatory Review ✅ Chemistry, Manufacturing, and Controls (CMC) ✅ Pharmacology/Toxicology (PT) ✅ Clinical & Clinical Pharmacology While not legally binding, this guidance reflects the FDA’s current thinking and provides valuable recommendations to facilitate the development of safe, effective, and high-quality CGT products. Remember: The use of “should” in FDA guidances means it’s a suggestion - not a requirement. Dive into the details and stay ahead in CGT innovation: https://lnkd.in/dqFj7sgq 🌟

BioBridges is 100% life science focused, and uniquely position to have our professionals embedded in sponsor companies, working within multi-disciplinary functions in concert with our CRO partners. Results mentioned by @Markbouck are a feather in our teams cap! #contractresearchorganization #clinicalresearch #clinicaltrials #CRO #clinicaloperations #clinicaldevelopment #fda

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Optimizing End-to-End Contract Analytical Support for Cell and Gene Therapies." Dive into this valuable guide to see how Alcami can bolster your CGT drug development with our all-encompassing services, including: • QC and Analytical Strategy Development: Customized approaches to guarantee quality and adherence throughout. • Method Development, Qualification, and Validation: Dependable methods for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage: Reliable storage options ensuring the safety of your substances across the supply chain. • Fill-Finish of DNA, RNA, and Other Raw Materials: Professional management to preserve the integrity of your essential elements. At Alcami, we are committed to aiding your progress in developing groundbreaking therapies. Get your copy of the white paper now and learn how we can collaborate towards achievement!** 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami

FDA FAQ Guidance The FDA released a draft guidance for Industry: Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products. This guidance answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products and is intended to help facilitate the development of safe, effective, and high-quality CGT products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology (PT), clinical, and clinical pharmacology. #fda #guidance #genetherapy #celltherapy #faq

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Enhancing Comprehensive Contract Analytical Support for Cell and Gene Therapies." Dive into this valuable guide to see how Alcami can bolster your CGT drug development efforts with our all-encompassing services, including: • Quality Control and Analytical Strategy Formulation: Customized approaches to maintain quality and adhere to regulations at each phase. • Methodology Development, Qualification, and Validation: Dependable methods for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage Solutions: Reliable storage options that safeguard your materials across the distribution network. • Fill-Finish Services for DNA, RNA, and Other Essential Materials: Skilled management to preserve the quality of your vital elements. At Alcami, we're committed to assisting you in pushing forward groundbreaking therapies. Get your copy of the white paper now and learn how we can collaborate towards achievement!** 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Optimizing End-to-End Contract Analytical Support for Cell and Gene Therapies." In this comprehensive guide, discover how Alcami can boost your CGT drug development efforts with our full range of services, including: • QC and Analytical Strategy Development: Custom strategies designed to maintain quality and adhere to regulatory standards at each phase. • Method Development, Qualification, and Validation: Dependable methods for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage: Reliable storage options ensuring the safety of your materials from production to delivery. • Fill-Finish of DNA, RNA, and Other Raw Materials: Professional management to preserve the quality of essential components. Alcami is committed to assisting you in pushing forward groundbreaking therapies. Get your copy of the white paper now and learn how we can collaborate towards achieving excellence!** 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Optimizing End-to-End Contract Analytical Support for Cell and Gene Therapies." In this valuable guide, discover how Alcami can enhance your CGT drug development journey with our all-encompassing offerings, such as: • QC and Analytical Strategy Development: Customized approaches designed to maintain quality and adhere to regulatory standards throughout. • Method Development, Qualification, and Validation: Dependable methods for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage: Reliable storage options that safeguard your substances at every step of the supply chain. • Fill-Finish of DNA, RNA, and Other Raw Materials: Skilled management to preserve the integrity of your essential elements. At Alcami, our commitment lies in aiding your progress in developing groundbreaking therapies. Download our white paper now to learn how we can collaborate towards achieving excellence! 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami

Who Can Afford the Most Expensive Drug in the World? After scoring an FDA nod for the first gene therapy to treat the rare genetic disease metachromatic leukodystrophy (MLD) in the U.S., Kyowa Kirin and its subsidiary Orchard Therapeutics have broken new boundaries in pricing, too. Orchard has set the wholesale acquisition cost for its one-time gene therapy at $4.25 million, making Lenmeldy the most expensive drug in the U.S. #genetherapy #celltherapy #gene #drugdiscovery #drugdelivery #medicalsciences #pharmaceutics #medicine #research #health #innovation #biotech #genetics

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Optimizing End-to-End Contract Analytical Support for Cell and Gene Therapies." Dive into this valuable guide where we detail how Alcami can bolster your CGT drug development with our all-encompassing offerings, including: • QC and Analytical Strategy Formulation: Customized approaches to guarantee quality and adherence throughout. • Methodology Development, Qualification, and Validation: Dependable techniques for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage Solutions: Reliable storage options ensuring the safety of your substances across the distribution network. • Fill-Finish Services for DNA, RNA, and Other Essential Materials: Skilled management to preserve the integrity of your key elements. At Alcami, we're committed to aiding your progress in bringing groundbreaking therapies to life. Get your copy of the white paper now and learn how we can join forces towards achievement!** 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami