26-28 March, 2018
ProArte Maritim Hotel, Berlin, Germany

Register by Monday, 15th January to save up to €400!

Analytical & Bioanalytical Day

2nd Annual Analytical & Bioanalytical Day – Monday 26th March

Enhance Molecular Understanding, Demonstrate Product Integrity & Satisfy Regulatory Requirements

09.00

Chair’s Opening Remarks

Alain Beck, Senior Director, Physio-Chemistry Department, Pierre-Fabre

Analytical Requirements for Development and Commercialisation of ADCs

09.15

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
Alain Beck, Senior Director, Physio-Chemistry Department, Pierre-Fabre
09.45

Speed Networking

10.00

Morning Refreshments & Networking

 11.00

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
 11.30

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.

12.30

Lunch & Networking

Integrating a Robust Bioanalytical Support Strategy

 13.30

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
14.00

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
14.30

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.

Roundtables:

  1. Regulatory Discussions
    • 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?
  1. Analytical Discussions
    • 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?
  1. Bioanalytical Discussions
    • 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
  1. Technical Discussions
    • 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
  1. Organisational Discussions
    • 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?
 16.00

Chair’s Closing Remarks

Alain Beck, Senior Director, Physio-Chemistry Department, Pierre-Fabre