(671e) Applications of Membrane Technology in Small-Molecule Pharmaceutical Processes

The application of membrane technology in large molecule pharmaceutical (or biologics) processing has garnered significant attention due to its ability to optimize separation processes, enhance product quality, and improve efficiency. The use of membranes in small-molecule (MW < ~1000 Da) pharmaceutical processing however has been limited. Membrane technology holds significant potential to improve pharmaceutical processes by increasing efficiency, reducing the Process Mass Intensity (PMI), and enabling continuous processing.

In this presentation, we intend to share a compilation of five case studies that underscore the diverse applications of membrane technology in pharmaceutical processing, in particular, nanofiltration (NF) and ultrafiltration (UF). The examples range from removal of organic, inorganic, and metallic impurities enabling downstream operations, to isolation of impurities, to purification and isolation of pharmaceutically relevant compounds, to drug product processing.

Collectively, these studies demonstrate the versatility and efficacy of membrane technology in various stages of pharmaceutical processing, paving the way for future innovations in the field. The findings suggest that integrating membrane solutions can lead to enhanced product quality, reduced environmental footprint, and significant cost savings.

In addition, this presentation will also highlight current challenges in broader application of membrane technology in the pharmaceutical process development.

Manish S. Kelkar, Akshay Korde, Brad Gates, and Nandkishor K. Nere are employees of AbbVie. The design, study conduct, and financial support for this research was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.