Shedding Light on Macromolecule Characterisation

Synopsis

Given the growth of the Biopharma sector and the number of Biosimilars making it to market one aspect of these products that still causes concerns is the risk of protein immunogenicity. There are several factors that play a role in immunogenicity, a key factor is the presence of aggregates, which when found in products can increase the risk of an immune response. Aggregates can be formed under a number of conditions and at various stages of the production, shipment or during delivery to the patient. Therefore, understanding and characterizing these macromolecules is an important aspect of bioanalytical analysis and patient safety.

This presentation will aim to provide a “how-to-guide” to aid your macromolecule characterisation efforts, and illustrate why it is critical to have a good understanding of the techniques when interpreting the results.

The inherently complex nature of a globular proteins mean that an overreliance on in silico modelling is a highly risky, yet surprisingly common, approach to take during early formulation development activities. Light scattering is highly sensitive to changes in the apparent size of a molecule; making it ideally placed for proteins and other macromolecule analysis. Experiments can be designed in such a way that allow for the development of robust formulations that are resistant to common causes of batch failure; such as agglomeration and sensitivity to temperature changes.