Cambridge Healthtech Institute’s Second Annual

Protein Aggregates and Particles
4-5 November 2015


Aggregation not only impacts a product’s developability, but can also affect its stability, formulation, and immunogenicity. Aggregation can occur at any stage from development to manufacturing, thus the detection, characterization and monitoring of all aggregates, particles and impurities is a major task in drug development. At the Protein Aggregates & Particles conference, we aim to understand the underlying mechanisms of aggregation; explore the impact of aggregates on safety and efficacy of biologics; develop tools to predict, characterize and minimize aggregates, SVPs and host cell proteins; design and engineer novel biotherapeutics with reduced aggregation and develop strategies to remove HCPs and impurities during process development.

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

MECHANISM OF PROTEIN AGGREGATION 

  • Understanding the mechanisms of large and small particle protein agglomeration and particle formation
  • Structural analysis and modeling to predict protein aggregation
  • Protein unfolding and loss of colloidal stability

AGGREGATES & IMMUNOGENICITY 

  • Exploring aggregation, immune-complexes and the immunogenicity of antibody therapeutics.
  • Characterization and control of in vivo aggregation
  • Clinical consequences of immunogenicity
  • FDA immunogenicity guidance: impacts on regulatory filings and clinical development

DETECTION, IDENTIFICATION AND CHARACTERIZATION OF AGGREGATES, VISIBLE AND SUB-VISIBLE PARTICLES

  • Development, qualification and implementation of analytical tools to study protein structure and dynamics as related to aggregation
  • Tools and techniques to characterize heterogeneity in biologics such as deamidation, isomerization, oxidation, disulfide scrambling, unfolding, etc.
  • Particulate analysis and quantification
  • Particle-based imaging to understand the particulate profile
  • Sequence modeling to predict protein aggregation
  • Measuring and characterizing aggregation at low and high protein concentrations

ENGINEERING PROTEIN THERAPEUTICS FOR REDUCED AGGREGATION 

  • Design of aggregation‐resistant biotherapeutics
  • Ligand interactions that promote protein stability and prevent aggregation
  • Engineering proteins to improve solubility and reduce aggregation properties

AGGREGATION IN NOVEL MOLECULES AND PRODUCT FORMATS 

  • Aggregation of bispecific antibodies, small alternative protein scaffolds
  • Propensity for aggregation in ADCs

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

Deadline for submission is 30 March 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