Scale-up of Pharmaceutical Isolation and Drying Operations

Rajniak, P., Merck & Co., Inc.

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



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2012 AIChE Annual Meeting
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Food, Pharmaceutical & Bioengineering Division only
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AIChE Food, Pharmaceutical & Bioengineering Division Members Free
AIChE Graduate Student Members Free
AIChE Undergraduate Student Members Free
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