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    Keynote Speaker for this Event: 

    • Noel Smith, Ph.D., Senior Scientist, Lonza Applied Protein Services, Lonza Biologics plc

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It is estimated that only 1 out of every 1,000 preclinical candidates reaches the commercial market. The ability to assess the “developability” of a therapeutic candidate in early preclinical and clinical phases of development can be a very powerful tool to enhance the chance of success. This webinar will discuss a number of methodologies to facilitate the assessment of potential development risks including:

  • safety and immunogenicity
  • stability
  • aggregation
  • low productivity

Unwanted immunogenic responses can have serious consequences on the efficacy of drugs and potential patient safety. A number of in silico methods can be used to evaluate protein sequence and structure in order to provide information on the likelihood of immunogenic responses and potential manufacturability issues such as: aggregation, deamidation, cleavage and post-translational modification.

In order to perform continued and more detailed developability assessments, it is essential to rapidly produce material representative of the final product. Both mammalian & microbial expression systems can be employed to rapidly produce material for discovery stage in vitro assessment.

Ex vivo systems are available to assess immunogenicity using both T-Cell and B-Cell responses to a therapeutic candidate. In addition, early representative material can also be used to monitor aggregation levels and detect other stability issues.

This webinar will present methodologies behind the following:

  • Protein Health Check – assessment of deamidation, stability, cleavage, post-translational modifications which can impact productivity and quality.
  • Epibase™ Immunogenicity Profiling – in silico screening platform and in vitro cellular assays.
  • AggreSolve™ Protein Aggregation Platform – in silico and in vitro platform designed to resolve protein aggregation and stability challenges.
  • Light Path™ Discovery Custom Material Supply – rapid generation of 10-250mg, non-GMP product for microbial or mammalian derived molecules.

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