Conference Presentation | Top Considerations for the Development of Inhaled Biologics

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Top Considerations for the Development of Inhaled Biologics

 

  • Inhaled and nasal biologics continue to grow in importance as advantages presented both by targeted delivery to the lung and systemic delivery for other diseases or treatment pathways, are driving this increased attention¬†
  • Top development considerations include analytical development to meet regulatory requirements of ICH Q6B, as well as the specific respiratory testing outlined in documents such as the EMA guideline on the pharmaceutical quality of inhalation and nasal products (June 2006) or the US FDA metered dose inhaler (MDI) and dry powder inhaler (DPI) products quality considerations guidance (April 2018).
  • In addition to specific OINDP tests, testing programs which fully characterize the biological entity and establish whether the device delivery mechanism has adversely affected parameters, including structure, purity (higher order structure, aggregation, degradation etc.) and the activity (potency), are required
  • Strategic formulation and device selection are necessary to optimize delivery

 

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