Cambridge Healthtech Institute’s 6th Annual
Biotherapeutics Analytical Summit
Part Two: Characterization and Compliance
Characterization, Impurities, Structure & Function, and Regulatory Concerns

March 10-11, 2015 | Hyatt Regency | Harbor Court | Baltimore, MD

Part Two of Analytical Characterization focuses on application of analytical technologies for a range of products including ADCs and multi-specifics. There will be a strong focus on characterization and control of aggregates and impurities, major challenges for the industry, and on linking structure with function using the most advanced technologies. Research indicates widespread interest in regulatory requirements as interpretation for each stage of development is difficult and because advances in technology mean the bar is constantly being raised. Industry and regulatory perspectives will be presented.

I am looking for case studies and reports on the following and similar topics: 

  • Characterization of Specific Product
    • New approaches to characterization of specific products such as ADCs, bispecifics and novel products

  • Concerns to do with Impurities 
    • Characterization and control of SVPs and aggregates
    • Development of analytical technology to detect product-related impurities and host cell proteins
    • Polymerase chain reaction testing for mycoplasma contamination

  • Regulatory Perspectives and Reference Standards 
    • Strategies for determination of acceptance criteria and specifications
    • Phase-specific requirements of the regulatory authorities
    • Industry case studies on developing a sustainable strategy for delivery of regulatory requirements
    • Regulatory approaches to handling new variants revealed by modern sensitive analytical technologies
    • Strategies for building in-house reference standards for early development through to commercialization

  • Linking Structure with Function 
    • Development of tools for measuring effector function
    • Excipients and formulation: How they affect stability and product characteristics
    • Characterization strategy to support CQA and lot release assays

Proposed Short Courses
 Host Cell Proteins: Identification & Control
 Characterization and Impact of Aggregates and SVPs
 Glycobiology of Antibodies

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:
Nicole Lyscom, Ph.D.
Conference Director
Cambridge Healthtech Institute
Phone: +44 7791 866489

For partnering & sponsorship information, please contact:
Jon Stroup
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute
Phone: 781-972-5483

Register Now 

2014 Brochure Download