
Homogeneity of pharmaceuticals plays a major role in fluid management. Liquid drugs have different viscosities, degrees of sedimentation, and other varying properties, making it difficult to standardize the aliquotation of liquids. If cell-based suspensions, antibody-drug conjugates, bacterial fermentation and others are not homogeneous, this will result in inconsistent distribution of particles and active ingredients in the aliquoted single-use containers.
Previously homogenization was performed through the manual manipulation of the 2D bag, which entailed the following risks:
- Breakage of single-use systems, resulting in contamination
- Unevenly filled bags with fluctuating volumes and concentration levels of sediments and pure liquids
- Unintentional heating of fluids, resulting in reduced product viability
- Ergonomic risks for operators
RoSS.PADL is a homogenizing solution with kneading and cooling functions for standardizing the mixing of biopharmaceuticals precedenting the dispensation into single-use bioprocess containers. According to a study conducted by Single Use Support in cooperation with the Institute of Hygiene and Medical Microbiology of the Medical University of Innsbruck it can be confirmed that the fully automated and hence standardized process ensures homogeneous distribution of the liquids in single-use bio process containers.
More information: Whitepaper: homogeneity in biopharmaceutical aliquotation