Comparability and Biosimilarity


Always an important consideration in late-stage development for QC and release testing, comparability is now even more of a concern particularly with ADCs and other complex multi-component, combination products, where batch-to-batch comparability poses a huge challenge. In addition, more and more biosimilars are expected to enter the foray of drug approvals in the coming years, giving more angst to companies trying to ensure analytical comparability of their biosimilars to the originators.

The Comparability and Biosimilarity conference aims to open up communication between regulators and industry to discuss the expectations, requirements, acceptable criteria, methodologies and reality concerning analytical comparability and biosimilarity, particularly on protein higher-order structure analysis and interpretation, forced degradation and stability testing, drug substance and drug product comparability, as well as comparability assessment for ADCs and other complex molecules.

We are currently inviting presentation proposals on the following preliminary topics: 

  • Higher Order Structure in Support of Comparability and Biosimilarity
    • Biophysical characterization tools for monitoring higher order structures of antibodies, ADCs and other novel formats
    • Current industry efforts to clarify role of higher order structure
    • Comparison of methods best suited to study higher order structure – NMR, CD, FS, H/DX-MS
  • Forced Degradation Studies in Support of Comparability and Biosimilarity
    • Design and application of forced degradation studies
    • Use of accelerated and stress data for extrapolation of expiration dating and for comparability studies
    • Appropriate tests to consider and meaningful data analysis
  • Comparability Assessment for ADCs and Complex Molecules
    • Impact of a change in linker or process chemistry during conjugation process can impact the higher order structure of an ADC.
  • Stage-Specific Strategies and Techniques for Comparability Assessment
  • Challenges in Comparability Assessment and Protocols
    • How much difference is different?
    • Lack of sufficient lots?
    • Managing risks during multiple changes and multiple sites
  • Drug Product Comparability
  • Bioassays for Comparability Assessment
  • Statistical Methods for Comparability
  • Regulatory Guidelines for Comparability and Biosimilarity

Please click here to submit a speaking proposal for review.

Deadline for submission: August 7, 2015 

All proposals are subject to review by the Scientific Advisory Committee to ensure the overall quality of the conference program. Please note that due to limited speaking slots, preference will be given to abstracts from those within pharmaceutical and biopharmaceutical companies, regulators and those from academic centers. Additionally, as per CHI policy, a select number of vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships. 

For questions about the meeting, please contact:
Mimi Langley
Sr. Conference Director
Cambridge Healthtech Institute
Phone: 816-472-0701
Email: mlangley@healthtech.com 

For partnering & sponsorship information, please contact:
Jon Stroup
Sr. Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5483
Email: jstroup@healthtech.com