CASSS CGTP 2025

June 10-12, 2025 

Rockville, MD 

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CGTP

Presentation by BioAgilytix

LUNCH SYMPOSIA
lynn-Kamen
Overcoming Challenges for Advanced Therapeutics:
Case Studies on Navigating the Unique Bioanalytical and CMC Characterization Landscape of Cell and Gene Therapies 
Presenters:  
 - Lynn Kamen, PhD, Scientific Officer 
 - Jessica Weaver, MRes, Scientific Officer
 
Wednesday, May 14, 12:15-1:15 PM 
Location: Room 383-385 

CMC analytical method development, validation, stability, and commercial release testing for biologics and ATMPs

BioAgilytix is the trusted partner for outsourced CMC analytical support for biologics and ATMPs from pre-IND to commercial release testing. Since 2008, we have specialized in solving challenging analytical problems and have supported commercial batch release since 2014. BioAgilytix has deep technical expertise in cell-based potency assays, molecular assays, MS characterization, and many other analytical test methodologies. Our consultative, science-forward approach leads to the best solutions for our clients, which range from emerging biotech to large pharmaceutical organizations. BioAgilytix offers cGMP testing in the US and EU, with laboratories located in Durham, North Carolina, and Hamburg, Germany. 

Schedule a meeting with our experts on site

Learn how the combination of world-class scientific expertise, outstanding project management, and key regulatory insight can streamline our support for your therapeutic.

Explore Resources by BioAgilytix Experts on Gene and Cell Therapies

Publication

Posters

Flow Cytometry as a Tool for Potency Determination in ATMP Development - WCBP 2025

Leveraging LC-HRMS Based Relative Expression/Potency Assay for mRNA loaded Lipid Nanoparticles - WCBP 2025
 

Webinar

Critical Attributes Analysis & Method Lifecycle Management for Biologics & ATMPs - Selection of Assay Platforms & Data Processing Methods for Potency Assurance - WCBP 2025

Explore Resources by BioAgilytix Experts on Gene and Cell Therapies

Publication

Poster

Flow Cytometry as a Tool for Potency Determination in ATMP Development - WCBP 2025

Poster

Leveraging LC-HRMS Based Relative Expression/Potency Assay for mRNA loaded Lipid Nanoparticles - WCBP 2025
 

Webinar

Critical Attributes Analysis & Method Lifecycle Management for Biologics & ATMPs - Selection of Assay Platforms & Data Processing Methods for Potency Assurance - WCBP 2025

Explore Resources by BioAgilytix Experts on Gene and Cell Therapies

Publication

Best Practices in qPCR and dPCR Validation in Regulated Bioanalytical Laboratories  

Poster

The Path to IDE - IVDR - Navigating the Evolving Regulatory Guidelines for Gene Therapies     

Webinar

 eChalk Talk: Bioanalytical Strategy for PK Assessments of ATMPs    

About the event 

The focus on Manufacturing, Quality, and Regulatory Considerations facilitates a platform for exchanging scientific ideas and engaging in dialogue with regulators, which underpins the evolving regulatory practices surrounding these diverse and innovative products. The 2024 Symposium will delve into how to adapt principles used for other biologics and how to develop new methodologies where necessary. This event will be available both in-person and live-streamed for a virtual audience. 

In 2023, the CGTP Summit made its debut as a new one-day program, separate from the Symposium. This Summit aims to address significant challenges in the cell and gene therapy sector in a more intimate setting. Consider extending your visit to enjoy the comprehensive four-day knowledge-sharing experience in cell and gene therapy. 

Rockville, MD

Schedule a meeting with our experts on site

Learn how the combination of world-class scientific expertise, outstanding project management, and key regulatory insight can streamline our support for your therapeutic.

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