How Predictable Stability and Solubility can Minimize Development Timelines and Cost

The market for solid state services (including salt, polymorph and crystallization screening) is around $150M and there is a growing trend from pharmaceutical companies to outsource much of this activity to CDMOs such as Cambrex. Entrusting your project to an outsourced supplier requires careful consideration and de-risking the solid form landscape of an API early in development is of utmost importance to ensure its success as a viable drug candidate. For example, facile hydrate formation can drastically alter the processability, stability and aqueous solubility of a given API, and therefore controlling the solid state properties of the API can ultimately benefit the downstream processing and manufacturing.

This presentation will discuss how predictable stability and solubility can minimize development timelines and cost. It will present two Cambrex case studies exemplifying the importance of understanding the hydration space of an API and how hydrate formation may be avoided by development of a robust crystallization procedure.

This webinar will:

  • Provide an introduction and overview of the solid state market
  • Discuss the importance of de-risking the solid state landscape of an API
  • Consider examples of typical issues faced during development of an API
  • Provide a brief overview of hydrates, and why understanding their formation is so critical

Cambrex’s Edinburgh site is a world-leader in providing solid form development services for drug substance and drug product.

Featured Speakers

Dr. David Pearson

Chief Scientific Officer
Cambrex Edinburgh

Dr Pearson joined Cambrex following the acquisition of Avista Pharma Solutions in January 2019. Previously, Dr Pearson led the solid state activities of Charles River Laboratories in Harlow (UK), supporting in-house drug discovery and development projects, with a focus on inhalation and external standalone projects. In 2017, Dr Pearson joined the team in Edinburgh to nurture its growth to a leading solid state group, supporting the pre-formulation development of APIs from discovery to commercial manufacturing and beyond.

Dr. Matthew Moorcroft

VP Global Market Intelligence & Communications
Cambrex

Dr Moorcroft joined Cambrex in 2014 as Vice President of Global Market Intelligence & Communications. He is also involved in the M&A and corporate development team that worked on a number of recent acquisitions helping Cambrex to become the leading end-to-end small molecule CDMO. Prior to Cambrex, Dr Moorcroft worked for Lonza in a number of roles including Vice President of Strategy, Director of Marketing Intelligence and Head of Global Marketing. Matt holds a Ph.D. in chemistry from the University of Oxford.

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