Whitepaper: Homogeneity in Biopharmaceutical Aliquotation

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. Study results confirm that the fully automated and hence standardized process ensures homogeneous distribution of the liquids in single-use bio process containers.