Cambridge Healthtech Institute’s 7th Annual

Biophysical and Structural Analysis
( 生物物理学的解析と構造解析 )

Implementing Emerging Technologies for Improved Product Quality and Accelerated Development Timelines

2019年4月10〜11日

 

Biophysical and structural analysis are now playing increasingly important roles in the discovery and development of next generation biotherapeutics. Developability assessment is now standard practice across the industry, and understandings gained at this step is now being applied in the optimization of candidates at early stages of the pipeline.  Higher resolution tools are enabling better understandings of how to characterize and control aggregation and particulates and are increasingly allowing these methods to be used in a quantitative, rather than qualitative way. The PEGS Biophysical and Structural Analysis conference brings together an international audience of protein scientists and analytical specialists to explore the latest technologies and methods for problem solving in this dynamic field and identify ways of optimizing the studies performed in support of regulatory filings and manufacturing.

Coverage will include, but is not limited to:

 

Higher Order Structure

  • Methods and instruments for assessing HOS
  • Structural analysis in characterization and comparability studies
  • The correlation of HOS results and long-term stability, safety and efficacy data

Implementing the Multi-Attribute-Method (MAM)

  • Lessons learned from early adapters
  • Software challenges in implementing MAM; data standards, communication across platforms
  • Regulatory issues: MAM data in CMC/analytical filings, implementing MAM as a release tool; internal FDA studies of MAM

Methods and Instruments

  • Miniaturization and increased throughput; new microscale and “on-a-chip’ technologies
  • What do we need to enable the use of biophysical methods in GMP/QC?
  • Emerging methods and instruments for biophysical and structural analysis

Spectroscopic Methods

  • Automating intact mass profiling 
  • Simplifying MS to expand users and applications; “walkup” MS
  • Emerging applications, instrument combinations, informatics   

Aggregation and Particles

  • Particle characterization challenges for emerging biotherapeutic formats
  • State of the science – improving detection limits for particle counting
  • Aggregation characterization and control in process development

Developability Analysis

  • Platforming developability analysis
  • Computational modeling for hot spot analysis
  • Candidate selection and developability analysis using biophysical techniques

 

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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