661 Scale-up of Pharmaceutical Isolation and Drying Operations

Thursday, November 1, 2012: 8:30 AM
Allegheny III (Westin )
Isolation and drying operations are the center stage of the downstream processing for manufacturing a high quality API drug substance whether it is a small or a bio-molecule compound. Successful scale up of such operations is dependent on obtaining a good understanding of process thermodynamics, physical properties of the crystalline particles, and mechanical stress environment within the isolation equipment. Often unique approaches for isolation and drying are needed to ensure high product quality /yield and optimal cycle times. Product quality includes maintaining the desired physical properties and polymorphic form of the product. This session invites presentations on innovative approaches for isolation and drying covering topics as below: (1) Enhancements of filtration or drying operations through process improvements (small molecule) (2) Novel drying technologies for bulk API, including technologies for maintaining desired physical properties and isolation of small/nano-particles, and also new developments in continuous filtration and drying operations (3) Advances in physical property control and performance prediction. Examples include (a) technologies for avoiding particle attrition/agglomeration, polymorph transformation, amorphous formation/loss of crystallinity and (b) laboratory tools for predicting the occurrence or extent of such adverse affects. (4) New modeling approaches for filtration and drying. Examples include estimating cake resistance and compressibility, drying rate modeling, mechanism understanding, or identification of unique controlling parameters to achieve the desired target profile (5) Polymorphic transformation studies during drying leading to successful scale-up (6) Purification approaches of biomolecules (proteins, peptides and MAbs) through filtration/drying (7) Applications of PAT tools in the development of filtration and drying


Pavol Rajniak
Email: pavol_rajniak@merck.com

Joseph Kushner IV
Email: joseph.kushner@pfizer.com

8:30 AM
(661a) Developing Improved Understanding of Spray Drying Through Process Modelling
Thoralf Hartwig, Francois Ricard, Ian C. Kemp, Mark A. Pinto and Sean K. Bermingham

9:20 AM
(661c) Development of a Laboratory and Mathematical Model to Predict Scale up Performance of an API Slurry Milling and Isolation Step
Edward Conder, Kevin D. Seibert, Carla Luciani, Eric Moher, Daniel Jarmer and Michael Phillips

9:45 AM
(661d) Manufacture and Control of a Hygroscopic Anhydrous API
Nathan Domagalski, Brendan C. Mack, Amanda Rogers, Jose E. Tabora and Lindsay Hobson

10:10 AM

10:35 AM
(661f) Multi-Scale Modeling of Pharmaceutical Spray Drying
Pavol Rajniak, Genong Li, David Johnson, Rick Falk and Justin D. Moser