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.
Advancing Vaccine Development With Novel Chromatography Solutions & Quality Testing
Learn more on novel chromatography solutions that can help improve the downstream processes of different vaccine types such as mRNA, recombinant proteins, and Virus-Like Particles (VLPs).
Why Clinical Requirements Change: Dr. Peter Marks on Pre-IND Meeting Pathways
Learn how clinical requirements change after the FDA and a company agree on a pathway during a pre-IND meeting and how the company might recover as a result.
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?
Patient Data's Impact On CMC Robustness
When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, sponsors may want to modify the protocol mid-study to increase patient enrollment.
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...
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.
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.
Microbial Identification Via DNA-Seq
Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.
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.
Key Regulatory Challenges, Innovations, And Opportunities For CGT 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...
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.
Interview With Nico Chow And Sandi True, Field Applications Specialists
Hear Nico Chow and Sandi True, Field Applications Specialists, discuss working with customers to help them evaluate and implement Residual DNA Quantitation, Mycoplasma Detection, and Microbial Identification Assays.
An All-In-One Solution For Residual DNA Quantitation
Explore an all-in-one solution for residual DNA quantitation with a 3D lab tour with virtual demos, videos, and interactive instrument guides to experience the full workflow.
Dr. Peter Marks Talks a Standardized Playbook for Gene Therapy Manufacturing
In this segment, Dr. Peter Marks shares developments in CMC for advanced therapies in the near future.
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.
Successful Microbial Testing And Identification
In this presentation, one of our industry-leading customers discusses how they've successfully implemented the Applied Biosystems MicroSEQ Microbial Identification System in their laboratory testing.
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.
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.
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.
What's New for 2024: Dr. Nicole Verdun Offers a Look Inside The Office Of Therapeutic Products
What is the Office of Therapeutic Products, where did it originate, and what's on its regulatory agenda for 2024?
A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation
Learn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.
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 ...
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.
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...
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.
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.
Key Considerations For Rapid Microbial Methods For Mycoplasma Detection
Learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.
A Straightforward Path Toward Regulatory Compliance & Data Integrity With Your Microbial Testing Systems
In this webinar, we will share a variety of strategies for implementing and validating microbial identification systems in the cGMP environment, possible difficulties along the way, and a comprehensive solution that addresses these challenges.
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.