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Developers of small molecule pharmaceuticals perform a battery of analytical tests before early clinical trials. These tests fulfil the regulatory requirements of the pharmacopoeia and are done in a standardised method. With small molecule drugs, the testing of the final product is relied upon.
In today’s complex world of biologics, however, success demands a completely different approach, as the process and the product define the drug and a more orthogonal approach to analytics is required.
What makes biologics different?
The intricacies of biological manufacturing, the large size and complex structure of the molecules, as well as the final…