Quality Assessment of Biologics Drugs

Unlike small molecule drugs, biologics are produced in living systems and have, not only primary, but secondary, tertiary and possibly quaternary structures. Determination of a biologic drug's higher order structure is critical to ensure efficacy, stability and safety.

NMR is perfectly situated to evaluate protein structures and fingerprint your biologic drugs to help determine if critical changes have occurred during a production change or similar event. Additionally, NMR fingerprinting to compare biosimilars to a reference material is fast and easy, allowing rapid evaluations of the biosimilars/biobetters in a first pass evaluation.

Finally, NMR is quantitative by nature, allowing assessment of biologic drugs in formulation and to evaluate if changes in structure (e.g. aggregation) have occurred during formulation or re-formulation again, allowing fast and easy evaluation without the method redevelopment of traditional LC methods.