Case Study

Analytical Procedure (Method) Lifecycle Management Drives Method Development At Innovative CDMO


Since 1959, contract development and manufacturing organization (CDMO) Hovione has helped its customers bring new and off-patent drugs to market. More than 1600 employees across four sites – in Portugal, USA, China, and Ireland – provide services for the development and compliant manufacture of new drug products.

As a global CDMO, Hovione has built a reputation for excellence and integrity, and the majority of the company’s customers contract for a complete package – across both development and manufacturing.

Hovione has proactively adopted MLCM and AQbD methodology to help their customers gain efficiencies, and improve the quality of their drug products, and the adoption of Waters UPLC and PDA/QDa technology has contributed to its success.

In this case study we explore how the combination of Waters instrumentation and AQbD is a powerful strategy for method development that leads to better, faster, greener analytical methods, as well as reduces costs and enables resource optimization. Hovione plans to actively pursue AQbD because of the significant benefits to its customers – and to the company’s business strategy.

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