Cambridge Healthtech Institute’s 8th Annual

Optimizing Biologics Formulation and Stability

New Tools, Technologies, Case Studies, and Research Updates on Development of Novel Biologics

August 26-27, 2020

 

The seventh annual Optimizing Biologics Formulation and Stability conference will cover latest trends and challenges in formulations development of novel biologic formats, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. We are seeking case studies, especially unpublished and innovative work on co-formulation, formulation of novel biologics, development and delivery of high-concentration protein formulations, effective scale-up strategies, excipient-induced instability, process challenges, fill-finish challenges, and predictive tools for rapid formulation and stability screening.

 

Coverage will include, but is not limited to:

 

  • Formulation and manufacturability of ADCs, bispecifics, other novel biologics formats, peptides, vaccines, cell-based and gene therapy
  • Co-formulations and combination products
  • Formulation approach to control protein aggregation and degradation
  • Excipient-induced protein degradation and aggregation, use of novel excipients and regulatory considerations
  • High-concentration protein formulations development: mechanism, fill-finish issues, managing viscosity and aggregation, devices, prediction, measurement of aggregation, viscosity, and solubility
  • Low-concentration formulations development
  • Product characterization, comparability, and correlation between early development studies and late-stage development studies
  • Predictive and high-throughput screening methods, forced degradation studies, new formulation technologies, DOE in formulation screening
  • New research and case studies for development of challenging lyophilization processes, fill- finish, scale-up, technology transfer, and manufacturing processes
  • Product presentation, container closure, and device engineering and its impact on formulation development and downstream manufacturing

 

* The program is subject to change without notice, due to unforeseen reason.





Premier Sponsors:

NanotemperTechnologies

Vironova