Cambridge Healthtech Institute’s Second Annual

Analytical Characterisation of Biotherapeutics
5-6 November 2015


Analytics play an important role throughout a product’s lifecycle, from candidate lead selection, to preparation for IND and characterizing for lot release. At Analytical Characterization of Biotherapeutics, we will take a closer look at advances in analytical technologies today that offer more accurate and faster methods to characterize complex biotherapeutics such as ADCs, bispecifics and fusion proteins; identify and explore PTMs and glycosylation effects on quality and stability of biologics; implement stage-wise comparability assessment from early to late stage development; as well as provide higher order structure analysis in comparability and biosimilarity assessment.

Topics will include, but are not limited to, the following: 

ADVANCES IN ANALYTICAL METHODS AND BIOASSAY DEVELOPMENT 

  • Advances in Mass Spec, HDX, differential scanning calorimetry, NMR, Circular dichroism, HPLC and UPLC, and technologies for higher order structure etc.
  • Measuring effector function: for MOA, ADCC, neutralizing antibodies, potency, stability and comparability

ANALYTICAL CHARACTERIZATION THROUGHOUT THE PRODUCT LIFECYCLE 

  • Analytical characterization for lead selection and developability assessment
  • Selecting for affinity, specificity, potency, biophysical improvements, and de-selecting for hydrophobicity, viscosity, stability and aggregate propensity etc.
  • Analytics to support CQA and lot release assays

POST-TRANSLATIONAL MODIFICATIONS 

  • Identification and characterization of PTMs for early stage IND and late stage BLA
  • Characterization of glycosylation and glycan profiling
  • Exploring the effect of glycosylation on the quality and stability of biologics
  • Structural and functional profiles of protein and glycoform engineered human IgG

CHARACTERIZATION OF DIVERSE MOLECULES AND NOVEL FORMATS 

  • ADCs, bispecific antibodies, fusion proteins, antibody mixtures etc.

CHARACTERIZING FOR COMPARABILITY 

  • Comparability assessment strategies and techniques for process, manufacturing site, formulation and post-approval CMC changes
  • Stage-wise comparability assessment – early to late-stage development

HIGHER ORDER STRUCTURE ANALYSIS FOR CHARACTERIZATION AND COMPARABILITY STUDIES 

  • Characterization of protein HOS in comparability and biosimilarity

If you would like to submit a proposal to give a presentation at this meeting, please click here.

Deadline for submission is 3 April 2015 

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, 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 more details on the conference, please contact: 

Mimi Langley
Senior Conference Director
Cambridge Healthtech Institute
Tel: +1 816 472 0701
Email: mlangley@healthtech.com 

For partnering and sponsorship information, please contact: 

Carol Dinerstein,
Director, Business Development
Cambridge Healthtech Institute
Tel: 1 781-972-5471
Email: dinerstein@healthtech.com 

Jason Gerardi
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5452
Email: jgerardi@healthtech.com