Solution Spotlight with Albumedix Formulation of Hard-to-Stabilize Biopharmaceuticals

11:30 - 12:05

  • Recombumin® for the formulation of next generation therapeutics: While in many cases the use of sugars, amino acids and detergents are sufficient there are many more challenging biologics where traditional approaches still fail or are suboptimal.
  • Recombumin® the importance of quality and reliable manufacture: cGMP quality meeting USP-NF standards. Commercially validated in marketed and late-stage clinical drug and vaccine candidates. Expert technical and regulatory support.
  • Recombumin® the importance of a controlled process: The lack of endogenous ligands guarantees batch-to-batch consistency and consequently performance reproducibility. Depending on the mechanism of albumin stabilisation we would expect a different influence of excipients, buffer components and, in case of serum derived HSA by endogenous ligand present.
  • Example: cells cryopreservation: the viability of cells was kept above the set release criteria, even after 72 hours and AlbIX maintained viability of the cells after thawing significantly better compared to HSA.

Eleonora Cerasoli, Senior Research Scientist, Albumedix