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DESCRIPTION:The updated ICH Q14 guidance from the FDA revising analytical 
 procedures used for release and stability testing has shown higher produc
 t quality expectations from regulatory agencies. As analytical studies be
 come an indispensable requirement to progress the antibody-drug conjugate
  space forward\, so has the need for rigorous analytical methodologies th
 at ensure product quality ahead of regulatory submissions.\n\nThe 3rd ADC
  Analytical Development will provide a technical deep-dive into optimizin
 g physiochemical methods to better quantify DAR and drug distribution\, c
 arry out size variant and charge variant analysis\, develop bioassays to 
 improve understanding of the potency in a timely fashion\, and better uti
 lize impurity assays to measure free-linker drug and overcome species sep
 aration\, to ensure you are producing a high-quality product within regul
 atory boundaries.\n\nJoin 100+ experts including Daiichi Sankyo\, Eli Lil
 ly\, ADC Therapeutics\, AstraZeneca\, and many more to gain an in-depth b
 ut holistic overview of all facets of analytical development that ensure 
 you deliver a high-quality\, safe and effective ADC that will progress th
 rough regulatory checkpoints.\n\nDesigned for analytical development\, CM
 C\, and quality control experts within the ADC field\, this is an excitin
 g opportunity to foster collaboration\, address need-to-know analytical c
 hallenges shared by the entire community and set a framework for future r
 egulatory clarity that you cannot afford to miss.\n\n&nbsp\;\n\nTime: 08:
 00 AM - 03:45 PM\n
DTEND:20240418T154500
DTSTAMP:20260512T220028Z
DTSTART:20240416T080000
LOCATION:Hilton Boston Back Bay\, 40\, Dalton Street\, Boston\, Massachuse
 tts\, 02115\,
SEQUENCE:0
SUMMARY:The updated ICH Q14 guidance from the FDA revising analytical proc
 edures used for release and stability testing has shown higher product qu
 ality ex...
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