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  4.  » Advanced Analytical Strategies for Large Molecules

Advanced Analytical Strategies for Large Molecules

Date: December 7, 2023
Time: 8:00 AM – 1:00 PM ET
Location: Boston Marriott Cambridge
50 Broadway, Cambridge, MA 02142

Small and mid-size biopharma companies are leading the way in biologics innovation, but they often encounter unique analytical challenges that can hinder progress. Some of the analytical challenges that these companies face include the complexity of biologics, which can make them difficult to quantify and characterize, the need for highly sensitive and selective methods to distinguish biologics from other molecules in biological samples, and the robustness and reproducibility requirements for analytical methods that are necessary for generating reliable data. Other challenges include the cost and time constraints associated with developing and validating analytical methods and the evolving regulatory landscape, which can make it challenging to keep up with the latest requirements. To succeed, it is crucial to select an optimal assay from the outset.

This event aims to provide guidance to overcome these hurdles, with a specific focus on the development and qualification of analytical methodologies. By attending this event, attendees will not only gain actionable insights into advanced analytical strategies but also have the opportunity to network with and gain access to experts who are troubleshooting the assay and analytical challenges that they encounter daily.


  • Gain insights into the characterization of charged variants through advanced techniques.
  • Learn about developing and qualifying mRNA-based potency bioassays for CGT products.
  • Understand the importance of forced degradation studies in ensuring the stability and efficacy of biologics.


08:00 am – 08:45 am
Registration and Networking Breakfast
08:45 am – 09:00 am
Tim Rice
Account Director, Biologics Analytical Services, Catalent
09:00 am – 09:40 am
Practical Approaches to Characterizing Charged Variants
Shawn Fitzgibbons
Senior Manager, Biologics Analytical Services, Catalent
09:45 am – 10:25 am
Best Practices, Strategies & Utilization of Novel Biological Responses for Robust Cell-Based Potency Assays
Pedro Morales
Director, Biologics Analytical Services, Catalent
10:25 am – 10:40 am
10:40 am – 11:20 am
Conducting Forced Degradation Studies of Biopharmaceuticals: A Case Study and Addressing Challenges
Luke Deters
Director, Biologics Analytical Services, Catalent
11:25 am – 11:40 am
Tim Rice
Account Director, Biologics Analytical Services, Catalent
11:40 am – 12:40 pm