The manufacture of biologics is a growing area, as companies are increasingly using the technology to develop better-targeted, more effective and safer drugs. However, biologics are not always as stable as small molecule drugs, and the manufacturing and storage process can introduce particulates. These can affect the shelf life of the drug, but more importantly, can expose already vulnerable patients to potentially life-threatening immunogenic responses. To remain competitive in the field, and to ensure the safety of patients, biologics manufacturers need to remain aware of ways to analyse and control particulates in their products.
Particles in biologics can be intrinsic (introduced as part of the manufacturing process or as aggregated particles of drug during storage) or extrinsic (arising from the drug container or device). By understanding what causes the development of particles and knowing how to control them, manufacturers of biological drug products can increase their chances of getting a product through regulatory approval, reduce the need for potential process changes or reformulation, and improve cost of goods and profit margins.
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