Comparative Study: Proving Performance Parity of the Gerteis Small-Scale Mill to De-Risk and Accelerate Development

New research available:

Data-driven decisions are at the core of successful drug development. We're excited to share our new comparative study on milling performance in dry granulation.

In pharmaceutical development, accurately predicting manufacturing outcomes with minimal use of expensive API is critical. A new comparative study by Serán BioScience validates the Gerteis Small-Scale Hand Mill (HM) as a powerful predictive tool for dry granulation processes.

Key Learnings:

  • Use gram-scale quantities of API to generate data that is directly representative of larger-scale processes.
  • Accelerate formulation screening and process optimization, saving valuable time and resources.
  • De-risk scale-up by establishing a reliable link between early-phase experiments and future manufacturing success.

Read the study to learn how Serán is enabling its partners to move programs forward with science-driven development processes.

 

Read the Study

About the Authors

 

Vedant G Bhagali, Scientist II

Hamad Haider, Scientist II (departed)

Randy J Wald, Drug Product Fellow; Vice President

Serán Bioscience LLC, Process and Product Development, OR 97701, USA , Gerteis Maschinen + Processengineering AG

 

Corresponding Author:

Randy J Wald

 

Acknowledgement: The authors would like to acknowledge Gregory R. Ellis of Serán BioScience for his contributions to the initial data collection & characterization.

About Serán

There's a science to success.®

Serán is a leading sci­ence-based CDMO that specializes in a variety of drug delivery and formu­lation approaches suited to optimizing bioavailability. Serán provides capsules, tablets, multi-particulates, and powder-in-bottle formulations. Our solid dosage forms are engineered for a wide range of formulation approaches such as overcoming solubility challenges and to enable extended-release.