Investigation into Clearance of Organic Compounds from Biomanufacturing Process Streams during Ultrafiltration/Diafiltration
The present work has created a strong background to describe the ability of UF/DF to remove potential organic leachables. Application of these modelling approaches becomes critical to support product safety assessments. Demonstration of significant removal along UF/DF operations confirms risk reduction of leachables coming mostly from upstream stages.
Institutions
- University College Dublin (IE)
- Johnson & Johnson (United States) (US)
- National Institute for Bioprocessing Research and Training (IE)
Publication Details
- Journal
- Pharmaceutical Research
- Published
- 2026-03-24
- DOI
- https://doi.org/10.1007/s11095-026-04050-2
- Primary Topic
- Protein purification and stability
- Type
- article
- Field-Weighted Citation Impact
- 0.00