Smart application of analytics in complex generic drug development

The Hatch-Waxman enactment triggered the birth of generic drug development almost four decades ago. It provided a legal framework and incentives for companies to research and develop generic drugs, but also attractive exclusivity periods for innovators of new drugs. It has shaped the modern-day pharmaceutical system, balancing innovation of new drugs against affordability of existing ones, with generics now accounting for the majority of overall sales within the pharmaceutical market. 

Underpinning successful generic drug registration and launch, particularly for complex generics, are diverse analytical chemistry techniques qualified within GMP-compliant laboratories. Specialized chromatographic, spectroscopic, solid state and bulk materials characterization methods are particularly important to demonstrate acceptable quality and performance ‘sameness’ to the innovator Reference Listed Drug. With first-to-file financial gains, an understanding of right-first-time targeted analysis is critical to accelerating RLD deformulation and improving the chances of successful trial and exhibit generic batches. Certain validated analytical procedures for the active drug or critical excipients are subsequently deployed for release testing of commercial batches. 

In this webinar, Dr Simon Bristow, Consultant Business Development Director at Malvern Panalytical’s contract services laboratories Concept Life Sciences, will provide a recap and overview of smart implementation of analytical characterization tools within the generic drug development process. Particular focus will be given to key enabling analytical solutions such as Morphologically Directed Raman Spectroscopy, XRPD and Size Exclusion Chromatography to meet Q2/3 regulatory requirements.

Vortragende

  • Dr Simon Bristow, Consultant Business Development Director at Malvern Panalytical’s contract services laboratories Concept Life Sciences

Weitere Informationen

What will you learn?

  • Recap and overview of smart implementation of analytical characterization tools within the generic drug development process 
  • Particular focus will be given to key enabling analytical solutions such as Morphologically Directed Raman Spectroscopy, XRPD and Size Exclusion Chromatography to meet Q2/3 regulatory requirements.