Access our on-demand webinar on preparing for a successful BLA submission.

The pathway to market authorization of a new biotherapeutic drug product is lengthy, complex and often experiences delays.

Fortunately, there are strategies to avoid these roadblocks, which can significantly improve timelines and increase your chances of successfully getting to market.

In this webinar, our experts will share insights about:

  • Our mitigation strategies
  • The unit operation of filtration
  • Our in-house approach to process characterization
  • The more complicated operation of lyophilization
  • The characterization of the resulting lyophilizate
  • Generating data for setting of a specification for residual moisture
  • Adapting to the new Annex I requirements for sterile manufacturing
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