Michael Platscher

It is both, challenging and inspiring, to work as a chemist together with our clients on multidisciplinary projects.

Perspective

Process Development at Merck KGaA, Darmstadt, Germany & Cie in Schaffhausen is focussing on the development and GMP manufacturing of Novel Excipients such as lipids and activated PEGs. When I joined our company in 1991 there was an growing demand of such compounds caused by the need to increase blood concentration and the circulation time of parenterally administered APIs - small molecules and proteins. Merck KGaA, Darmstadt, Germany recognized this trend at the right time and formed the Drug Delivery Compounds (DDC) business. In the following years new pharmaceutical approaches like gene silencing with siRNA, cancer vaccines, expression of proteins by mRNA and lately gene editing by CRISPR/CAS9 required new delivery approaches and boosted the DDC business. 

It is both, challenging and inspiring, to work as a chemist together with our clients on multidisciplinary projects. Biopharmaceutical formulations are very complex and their mode of action has to be understood in detail. Small changes in the composition, e.g. caused by small impurities, can have a huge impact on the functionality of the medication. This forces us to develop robust manufacturing processes which always generate the product in very high quality and with a defined impurity profile, from preclinical up to commercial material.

In early 2018 the Global Contract Manufacturing Services organization was formed which is bundling the A&F custom manufacturing activities of production sites (Schaffhausen, Madison/Verona and St. Louis) including the installation of a global Process and Analytical Development unit (PAD). My American colleagues are specialized on the development of HPAPIs and ADCs. The focus fields of all three development groups are complimentary. The new organization is a perfect match which offers comprehensive services to the present pharmaceutical world. 
It motivates me that our company is deeply committed to this business and constantly investing in new technologies, equipment and the development of its employees.

It motivates me that our company is deeply committed to this business and constantly investing in new technologies, equipment and the development of its employees.

Michael Platscher

Associate Director of Process Development Global Contract Manufacturing Services

Profile

Joined Merck KGaA, Darmstadt, Germany: 1991

Key research fields and topics:

  • Synthetic lipids for the parenteral delivery of APIs (e.g. siRNA, mRNA and small molecules).
  • Process development, scale-up and GMP manufacturing of Novel Excipients

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CV & Scientific activities

CV: Education

CV: Education

1978 - 1984
Studies in organic chemistry, University of Konstanz (Germany)
1984 - 1988
PhD thesis at Prof. Dr. R. R. Schmidt, University of Konstanz (Germany)

CV: Professional Career

CV: Professional Career

1984 - 1987
Scientific Assistant, working group of Prof. Dr. R. R. Schmidt
1988 - 1989
Postdoctoral position, working group of Prof. Dr. E. Wenkert, University of Konstanz (Germany)
1990 - 1991
Assistant, Patent Department, UCSD, San Diego (USA)
1991 - 1999
Project Leader, Synthesis & Development, BASF AG, Ludwigshafen (Germany)
1999 - 2009
Project Leader and Project Evaluation, Synthesis & Development
2009 - 2017
Senior Project Manager Drug Delivery Compounds, Synthesis & Development, Lipids
since 2018
Associate Director of Process Development Global Contract Manufacturing Services, Lipid & Activated PEGs, Merck KGaA, Darmstadt, Germany & Cie, Schaffhausen (Switzerland), formerly Eprova AG

Expertise

Expertise

  • Synthetic lipids
  • Activated PEGs
  • Process development
  • GMP manufacturing
  • Active targeting

References

Patents
 
  • DOTAP enantiomers
  • Crystalline DOTAP
  • Crystalline DOPC
  • Lipids for active targeting

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