Formulation of Hard-to-Stabilize Biopharmaceuticals
14:15 - 14:50
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 HSA 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.
Dr Phil Morton has a strong technology background with over 20 years’ experience in the biopharmaceutical industry within process and product development as well as product application research. He was trained as a biochemical engineering and has biopharmaceutical experience in both R&D and manufacturing environments in companies such as Delta Biotechnology, Aventis and Novozymes. Phil holds a Ph.D. in Biochemical Eng. from Birmingham University and followed this with post-doctoral studies at Cambridge University before moving into industry.