Cambridge Healthtech Institute’s 6th Annual
Biotherapeutics Analytical Summit
Part Three: Comparability for Biologics
Assessing and Overcoming Comparability Challenges for Biologics & Biosimilars
March 12-13, 2015 • Hyatt Regency • Harbor Court • Baltimore, MD
In the lifecycle of a biotech product, manufacturing changes (process, site, equipment) to the drug substance or drug product are to be expected. When such changes occur, manufacturers need to demonstrate sufficient and appropriate comparability between pre-change and post-change to ensure that the safety and efficacy of the product remains intact. The biggest challenge therein, lies in what constitutes “sufficient” and “appropriate”? How do you know what may/may not be affected and what needs to be tested? When do you need to conduct such assessments? How much information is sufficient? What techniques should you use to obtain the best possible comparison? These and many other questions are on the minds of many analytical scientists as the products move along the development pathway, from early stage to formulation.
The Comparability for Biologics conference brings together scientists and engineers from core analytical lab, drug development, process sciences, formulation, manufacturing, QA/QC and regulatory affairs to share strategies, approaches and technologies that will help overcome these comparability questions and challenges.
We invite proposals on the following preliminary topics:
- Regulatory Perspectives on Comparability Assessments of Biotech Products
- Comparability Assessment During Drug Development
- Facility changes
- Process changes – upstream, downstream
- Formulation changes
- Stage-Specific Strategies and Techniques for Comparability Assessment
- Early Stage/Drug Development
- Late stage/Post-Approval
- Challenges in Comparability Assessments and Protocols
- How much difference is different?
- Lack of sufficient lots?
- Small company strategie
- Managing Risks during multiple changes/multiple sites etc.
- Comparability for ADCs
- Testing Strategies and Criteria
- Setting Acceptance Criteria
- Determining CQA
- What tests to conduct?
- QbD and design space
- New/Emerging Strategies for Comparability Studies
- Comparability for Biosimilars
- Tools and Techniques to establish biosimilarity
- Higher Order Structure Analysis for Biosimilarity Comparison
Proposed Short Courses
Biophysical Characterization for Comparability Assessment
Comparability and Biosimilarity: Principles and Case Studies
Please click here to submit a speaking proposal for review.
Deadline for submission: September 5, 2014
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:
Sr. Conference Director
Cambridge Healthtech Institute
For partnering & sponsorship information, please contact:
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute