Biopharmaceutical manufacturing and quality control are cost- and time-sensitive processes, reliant on many other aspects of drug development in order to progress smoothly. Modern medicines require high concentration, high quality, complex products which are often delicate and prone to damage or heterogeneity as a result of the slightest change in process or formulation.
At Malvern, we understand the requirement to monitor molecules and formulations as closely as possible for critical quality attributes to ensure product quality, safety, stability and homogeneity.Our suite of solutions for analysis of biopharmaceutical formulations during both upstream and downstream processing enables rapid and intuitive examination and a wealth of vital information on oligomerization, aggregation, sizing, viscosity, charge and contaminants of various types.
Our Zetasizer and Viscotek range of instruments are often used to give real-time data on oligomerization, zeta potential and aggregation state, while Archimedes and the Nanosight range of instruments give further information on aggregation and Archimedes can also elucidate the contamination state of the product. Malvern’s Viscosizer TD provides automated sizing data for peptides and proteins within even very complex formulations, and rapid, high-throughput viscosity analysis at all stages of development.
At Malvern, we work alongside our customers to understand their challenges and requirements, and closely monitor the changing regulatory landscape, to ensure that our solutions are kept current and continue to offer the valuable time and cost benefits that you expect.