In the process of developing and producing a new medicine, the Biochemical team develops and optimises the processes needed to obtain high-quality, high-purity therapeutic proteins. The laboratory draws on sophisticated purification techniques and extensive analytical support to define the most effective process conditions and characterise the product at various stages of development, or in other words to determine – comprehensively and in detail – all the chemical, physical, biological and structural properties of a molecule or substance.
The core of the work is the development and optimisation of protein purification processes, involving the use of advanced liquid chromatography systems. These tools make it possible to develop and compare different chromatographic strategies, by selecting the best chromatographic matrices and optimising loading conditions, pH, ionic strength and elution gradients. This approach results in the design of efficient purification processes that deliver reproducibility and high levels of purity and process yield.
Process development is supported by a sophisticated analytical characterisation system. Techniques such as high-performance liquid chromatography (HPLC), spectrophotometry, one-dimensional (SDS-PAGE) and two-dimensional (2D) electrophoresis, and isoelectric focusing (IEF) are used to assess the purity, identity, integrity and physical-chemical characteristics of proteins during the various stages of the process. These are complemented by enzyme-linked immunosorbent assay (ELISA) systems and collaborative analyses with other IBSA teams to study in vivo biological activity and perform detailed characterisation using mass spectrometry. All this data is processed to obtain essential information that guides the development and optimisation of production and purification processes.
The Biochemical Laboratory also develops cell culture processes for the production of recombinant proteins. Bioreactors – in which cells grow under controlled conditions – are used to study and optimise growth conditions and so ensure the quality and reproducibility of the product. The integration of cell culture development, purification and characterisation results in the comprehensive evaluation of processes and the identification of the most suitable conditions for the production of recombinant proteins.
As part of its development work, the laboratory also coordinates viral validation studies, designed to demonstrate that the manufacturing process can deliver an adequate level of viral safety. These activities help to ensure that processes for the manufacture of injectable medicines are developed in accordance with rigorous quality and safety standards, in line with current international guidelines.