Error loading player: No playable sources found

Plenary Session 4 - Old Dog, New Tricks: Harnessing the Hidden Potential of Established Analytical Technologies to Drive Complex Product Characterization

Date
January 29, 2025
This product is not available for individual purchase, but it is available as part of the following products:

Innovations in therapeutic modalities are continually emerging as viable treatment options for a multitude of disease indications. These novel therapies can be complex biologics with multiple product components such as bioconjugates, volume limited therapies where the suit of established characterization and release testing cannot be performed due to low volumes as in the case of certain Cell and Gene therapies or molecules that are invisible by established analytical tools. Re-evaluation of established analytical technologies or reimagining the use of established analytical tool kits to provide novel characterization approaches can accelerate and enhance product understanding.  

In this session we will explore case-studies where established technologies are enhanced or leveraged in a novel manner to characterize complex therapeutic modalities. Additionally, we will explore the current state of the art analytical tools utilized for process analytical technologies and release testing. We will discuss which technologies are QC ready and which remain as characterization tools in the development labs. This session will highlight the evolving trend of reimagining established analytical technologies to tackle the characterization and product release challenges posed by the modern-day innovative therapies.  


Session Speaker:


A Novel, High-Throughput Imaged Capillary Isoelectric Focusing (iCIEF)-Western Method to Characterize Charge Heterogeneity of Monoclonal Antibody (mAb) Heavy and Light Chains 

Gangadhar DhulipalaRegeneron Pharmaceuticals Inc.


Genetic Medicine Characterization via 2nd and 3rd Generation Sequencing Tools

Beth OstranderPfizer, Inc.


Carly Daniels, Pfizer, Inc. 


Additional Panelists:


Methal Albarghouthi, AstraZeneca


Da Ren, BioTherapeutics Solutions


Nadine Ritter, Global Biotech Experts, LLC


Related Products

Thumbnail for Parallel Session 2B- LER 2025: Strategies Today for Overcoming Low Endotoxin Recovery
Parallel Session 2B- LER 2025: Strategies Today for Overcoming Low Endotoxin Recovery
Monitoring and control of endotoxin are critical aspects of an overall microbial control strategy necessary to ensure drug product quality and patient safety…
Thumbnail for Parallel Session 2A - Science vs the Fear Factor: Alternative Potency Assays for Recombinant Biologics and Vaccines
Parallel Session 2A - Science vs the Fear Factor: Alternative Potency Assays for Recombinant Biologics and Vaccines
Potency analytical control strategies are critical to support biopharmaceutical drug and vaccine development throughout the product lifecycle…
Thumbnail for Parallel Session 6B: The Critical Need to Protect the Horseshoe Crab: Initiatives from Industry, Suppliers and Regulators to Replace the LAL Assay
Parallel Session 6B: The Critical Need to Protect the Horseshoe Crab: Initiatives from Industry, Suppliers and Regulators to Replace the LAL Assay
The pharmaceutical industry is increasingly viewed as a key sector systemically important in reversing nature loss.     One of the sector’s key dependencies is on the horseshoe crab , a species that is vital to marine ecosystems only located in a few locations globally…
Thumbnail for Turning Mandates into Momentum: How CASSS Can Help Sonia Vallabh?
Turning Mandates into Momentum: How CASSS Can Help Sonia Vallabh?
As a follow-up to Tuesday's very impactful Keynote presentation, join us in-person or online as we come together as a community and brainstorm ways to further Sonia's mission to prevent prion disease…