REGULATORY GUIDANCE AND ENABLING COMPLIANCE
Simple In-House Mycoplasma Testing Method For Regulatory Expectations And Rapid, Confident, And Actionable Results
In this webinar, we present an overview of worldwide regulatory guidance for mycoplasma testing, as well as a mycoplasma testing method that has been accepted by regulatory authorities worldwide across various therapeutic modalities.
Innovative Contamination Control: Enabling Integrity And Efficiency
An integrated approach can enhance contamination control, boost process efficiency, and ensure the production of high-quality cell therapy products.
Race To The Regulatory Finish Line: Dr. Nicole Verdun Talks Efficiencies In Platform Technologies
Could a platform approach help certain therapies make their way over the regulatory finish line more efficiently?
Challenge #2: Rare Or Ultra-Rare Study Design Considerations And Use Of Existing Data
There are more than 7,000 unique, rare diseases recognized in the United States, and 300 million people worldwide living with a rare disease; patients often experience a long journey to receive their diagnosis. Our expert panelists, Nina Hunter, Ph.D., VP Corporate Strate...
Major Trends Impacting Allogeneic Cell Therapies For Oncology
We kicked off this Cell & Gene Live, Unlocking the Future of Allogeneic Cell Therapy for Oncology by discussing the major trends impacting allogeneic cell therapies for oncology.
Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials
Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.
Challenge #3: Lack Of Animal Models
Many cell and gene therapies are intended for diseases and conditions that primarily impact pediatric patients, requiring the prospect of direct benefit to individual subjects enrolled in the trial. In the absence of good animal models, there may be challenges demon...
Leveraging dPCR r Techniques To Quantitate Lentivirus Particles
Discover how digital PCR can streamline lentiviral vector characterization to reduce variability and improve analytical sensitivity. Learn how this approach can help you comply with regulatory guidance.
Tackling Cell And Gene Therapies' Top 3 Regulatory Impediments: Audience Q&A
During each Cell & Gene Live, our audience has the opportunity to submit real-time questions for our expert panelists. Watch and listen as Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio p...
A Successful Journey To Cell Therapy Manufacturing
Learn about the three main areas to consider when you're preparing to commercialize a cell therapy, including starting/raw material, the controlled manufacturing process, as well as testing safety and quality.
Innovations In Mycoplasma And Sterility Testing For Biopharma
In this webinar, our expert speakers will discuss the types of analytical testing that can be effectively employed in the early stages of therapeutic development and subsequently scaled to meet production challenges.
CGT's Main Opportunities To Meet Regulatory Requirements
Host and Moderator, Erin Harris, Chief Editor of Cell & Gene, began this Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, featuring Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regul...
How The FDA's 2024 Draft Guidances Will Influence CGT Regulation In 2025
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
Focal Points for 2024: Dr. Verdun and Dr. Marks Talk Regulatory Challenges for Cell-Based Therapies
Dr. Verdun and Dr. Marks provide detailed feedback on the regulatory challenges facing cell therapy and explain the Agency’s most important focal points for 2024, patient accessibility, and more.
Maximize Quality Assurance Through Rapid Sterility Testing
This webinar explores mitigating the risk of product loss, and production delays, as well as the critical role rapid sterility testing plays in ensuring the quality and safety of cell therapy products.
Navigating Global Regulatory Landscapes In An Evolving Biopharma Industry
Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.
Dr. Peter Marks on the Adoption of Novel Precision Analytics
Hear advice for developers who are worried that the FDA will not accept changes in their process that include a new analytical method.
Microbial Identification Via DNA-Seq
Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.
Best Practices For Effective Donor Management
Starting with high quality donor material is critical for allogeneic cell therapy drug manufacturing, and this requires laying the groundwork for a high-touch, end-to-end donor pool management strategy.
Challenge #1: The Changing Regulatory Landscape
By 2030, 60 CGTs are expected to reach regulatory approval. One of the biopharmaceutical industry's most closely watched regulatory developments is the FDA’s reauthorization of the Prescription Drug User Fee Act (PDUFA) or PDUFA VII, as it provides resources for...
Leveraging Rapid Sterility Testing To Advance Cell Therapy Production
Explore the crucial role of rapid sterility testing in cell therapy manufacturing. This presentation delves into the benefits of swift, accurate detection for product quality and patient safety.
ResDNASEQ Workflow Solution
Explore the Applied Biosystems resDNASEQ workflow solutions. Starting with the sample preparation kit, to purification, quantitating residual host-cell DNA, and analyzing resDNASEQ assays.
Understanding AI And Machine Learning's Impact On CGT with Dr. Peter Marks and Dr. Nicole Verdun
During this segment, Dr. Peter Marks and Dr. Nicole Verdun share their take on how AI and machine learning will impact FDA regulation in 2024.
CAR-T Innovation: Balancing Allogeneic And Autologous Cell Therapy
Join experts as they discuss strategies for optimizing allogeneic and autologous therapies, aiming for balanced development and wider patient accessibility by 2030.
Cell And Gene Therapy Innovations
This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.
Navigating Global Regulations, Equity Challenges, And The Future Of Patient Access
Kimberly Benton, Ph.D., Master Principal and Head of Regulatory at Dark Horse Consulting and Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Director, Clinical Research and Early Product Development Center for Cell and Gene Therapy, Professor of Pediatrics Baylor College of Med...
Collaborating with the FDA: Dr. Peter Marks and Dr. Nicole Verdun Share Advice For Small And Emerging Biotechs
In this segment, Dr. Peter Marks and Dr. Nicole Verdun share their advice and best practices for small and emerging biotechs when working with the FDA.
Other CGT Regulatory Challenges
During this segment of Cell & Gene Live, Tackling Cell and Gene Therapies’ Top 3 Regulatory Impediments, Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO and Adora Ndu, PharmD, JD, Chief Regulatory Affairs Officer at BridgeBio detail their own experiences ...
Explore The Analytics Knowledge Hub
Discover smarter solutions with the new Analytics Knowledge Hub that provides articles, webinars, e-books, and infographics designed to enhance and streamline your bioprocess workflow.
Implementing Rapid Microbial Identification In Biotherapy Manufacutring
Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.