Silke Schumacher-Ben Hassine’s Post

FDA FAQ Guidance The FDA released a draft guidance for Industry: Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products.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

Important quick guide for CGT development

📢 NEWS - FDA Draft Guidance on FAQs for Cellular and Gene Therapy Products The FDA has released a draft guidance document addressing common questions and challenges faced during the development of cellular and gene therapy products. The guidance covers critical areas such as regulatory review, CMC, pharmacology/toxicology, clinical considerations, and clinical pharmacology. Its goal is to facilitate the creation of safe, effective, and high-quality therapies. The FAQs are based on inquiries from sponsors, feedback following FDA public presentations, and input from stakeholders via CBER. The guidance is open for public comment and may be updated in the future to include additional FAQs. Contact us at [email protected] to learn how we can help you navigate this guidance or other regulatory requirements. #CGT #CellularTherapies #GeneTherapies #RegulatoryAffairs

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

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

(Benefit-Risk Management / Cell and Gene Therapy / New US FDA Draft Guidance FAQ) If you're in the CGT space, this would be a should/must-read document. Topics range from nonclinical to clinical safety designs. Enjoy. #fda #cder #drugs #biologics #cber #cgt #celltherapy #genetherapy

On 28 December 2023, USFDA published a draft guidance for potency assurance of cell & gene therapy products, listing recommendations and approaches to develop CGT potency assays (https://lnkd.in/gJ6KVDvv), which will supersede the January 2011 Guidance, titled "Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products". A helpful summary of the draft guidance had been composed in this link (https://lnkd.in/gCctpdYT)

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

Unlocking the future of cell and gene therapy (CGT) requires solutions for complex manufacturing. Drs. Hien-Anh N Bruno and Deven Shah of Certara share strategies to optimize viral vector production, ensure consistent quality of gene editing therapies, and overcome other CGT challenges. Check out this informative article and find out how to advance your CGT development. Read more: https://ow.ly/gokm50Se6c6 #CellAndGeneTherapy #CMC #PharmaceuticalManufacturing #Pharmaceutical #DrugDevelopment #Pharma #PharmaceuticalAnalysis

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