8th American Drug Formulation and Delivery Summit10 Sep 2018
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Formulation of Hard-to-Stabilize Biopharmaceuticals
Dr Phil Morton, Chief Technology Officer, Albumedix
- Recombumin® for the formulation of next generation therapeutics: While in many cases the use of sugars, amino acids and detergents are sufficient there are a number of more challenging biologics where traditional approaches still fail or are suboptimal.
- 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 human serum albumin by endogenous ligand present.
- An example is the cryopreservation of stem cells: the viability of the stem cells was kept above the set release criteria for longer using AlbIX compared to HSA.