Analytical Requirements for Development and Commercialisation of ADCs
Keynote: Cutting-Edge Mass Spectrometry Methods for the Multilevel Structural Characterization of Antibody-Drug Conjugates
Address challenges in ADC heterogeneity and inherent microvariability of the molecules
Learn to robustly assess several critical quality attributes – namely the distribution and position of the drug, the amount of naked antibody, the average DAR and residual drug-linker and related properties
Explore new mass spectrometry (MS) methods and improve multiple-level structural assessment protocols
Review a case study of application of novel techniques and critical quality attributes for Kadcyla and Adcetris
Evolving Methodologies When Dealing With Different Payload and Linker Types
Measurements of the levels of small molecule free drug species in the presence of large molecules (ADCs)
– Protein precipitation – complicated by optimized formulations
– HLPC columns with restricted access materials (REM)
– Multiple 2D-LC methodologies
Linkage isoforms – double peaks in chromatograms
Degradations of cytotoxic agents induced by light and pH
Alex Lazar, Director Analytical and Pharmaceutical Sciences, ImmunoGen
Mastermind Discussion Groups
Collectively brainstorm the future challenges and opportunities within ADC CMC method development. Gain insights and perspectives from stakeholders at all stages and within multiple functions. Identify key criteria for ongoing development strategy.
Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtables, they will present back to the entire delegation as part of a panel discussion for information dissemination.
Lunch & Networking
Integrating a Robust Bioanalytical Support Strategy
Developing Assay Sets to Screen for ADC Biotransformations
PK of ADCs are more complex than that of antibody and cytotoxic drug alone
Novel assays are required to truly understand the behaviour of ADCs and drug intermediates in vivo
Lessons learned from working with PBD-ADCs
Conor Barry, Analytical Group Leader, MedImmune/Spirogen
Analysis of Charge Heterogeneity in Monoclonal Antibodies with Introduced Cysteines
Antibodies with introduced cysteine residues permit site-specific conjugation of a payload to produce stable and homogeneous ADCs
Charge heterogeneity of the antibody intermediate is analysed as part of lot release and stability testing, contributing to the quality control of the final ADC product
The charge profile of an antibody intermediate with introduced cysteine residues was found to be more complex than that of a regular monoclonal antibody. The causes and implications of this complexity will be discussed
Richard Shannon, Scientist I, MedImmune
Think Tank Roundtable Sessions
More practical and highly interactive breakout roundtables where attendees can crowdsource solutions and share opinions around pre-assigned topic areas. A valuable chance for attendees to unite around hot topics and debate best practice. No more sitting quietly, this is a dedicated opportunity for you to voice your experiences and identify unique solutions.
There will be two 45 minute sessions with the opportunity to change groups halfway through.
Preparing for IND; what do you need to think about and what could trip you up going forward?
Current standards and expectations from regulatory authorities
What to look for and what not to; is too much knowledge a dangerous thing?
Quantification and characterisation of intact ADC and intermediates
Process chemistry changes in mAb vs conjugation vs small molecule
What are the gaps in our analytical capability?
Immunogenicity assessment and other preclinical safety considerations
Utilising cell-based assays to drive mechanistic understanding early on in preclinical development
What do unvalidated assays fit into your development and how can they support your molecular understanding
Data management and sample handling when scaling up ADC analysis
Speeding development through optimized assay workflow
ELISA vs mass spec; what to use and when
Breaking down cultural silos and improving integrating and understanding across discovery, development and CMC
Where do outsourced vendors fit in, partner or provider?
How early do you need to starting thinking about analytical method development and quality control?
Maritim proArte Hotel Berlin
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