The Argument for Albumin
Products are becoming increasingly complex and we need to get better at recognizing the strategies with the best advantages.
Phil Morton |
Increasingly, the industry is seeing a move away from proteins and peptides towards even more complex drugs, such as antibody drug conjugates, new viral vaccines and cell-based therapies. Of course, such therapies come hand in hand with greater formulation challenges – and in many cases standard formulation technologies are no longer up to scratch. For example, lipids present in vaccine and cell-based therapies can be broken up by standard excipient approaches, while products that require high concentrations, such as antibodies, can be limited by viscosity issues. The incidence of multiple problems, such as aggregation and oxidation occurring simultaneously, is also common in more advanced biopharma products.
In my view, the use of albumin is very effective in formulating complicated products. The stabilization properties of human-serum derived albumin were once well recognized in the industry, but with issues such as Creutzfeldt-Jakob disease and AIDS, serum-derived albumin use declined due to the potential risks. Today, with the availability of recombinant albumin, these risks are eliminated. However, as the industry has moved away from the use of albumin (instead using sugars, amino acids and detergents), many in industry have forgotten the benefits that albumin can bring. It is time to reacquainte the industry with the benefits of albumin. There really is so much to explore that companies are perhaps unaware of, particularly when it comes to early development.
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