31 October 2018

Performance Materials at Merck KGaA, Darmstadt, Germany: Key Player towards the success of the Pediatric Praziquantel Program

The broad contribution by Merck KGaA, Darmstadt, Germany to the Pediatric Praziquantel Consortium includes the significant support by the Performance Materials business sector for the development of the PZQ Active Pharmaceutical Ingredient (API) and the timely material supplies for the clinical trials.

Beyond its contribution to the Pediatric Praziquantel program in the pre-clinical, clinical, regulatory and access areas, Merck KGaA, Darmstadt, Germany has been also providing expertise and resources in drug substance/drug product development and manufacturing.
Specifically, the Performance Materials (PM) business sector of the company has significantly participated in the program, through in kind contribution, to develop a process for the Active Pharmaceutical Ingredient (API) of the L-PZQ orodispersible tablet (ODT) formulation.  In addition, jointly with Drug Substance experts from the Healthcare sector, PM has also delivered the required drug substance supplies enabling the manufacture of investigational drug product for the clinical development program.
During the development of the API process, control of Costs of Goods has been an essential element to ensure an affordable price of the final product at launch.  The technology transfer to a valuable strategic partner (contract manufacturing organization) is also allowing to establish a comprehensive service from process development to scale-up for industrialization in order to support reliable and sustainable commercial supply. 
This contribution has been critical for the achievements of the program so far, and will continue to be instrumental, showcasing, once more, Merck KGaA’ s strong commitment to the fight against schistosomiasis.