Bioprocessing and biopharmaceutical development

Recombinant protein production is powerful technique widely employed in biology research labs around the world and for the industrial-scale production of therapeutic proteins and industrial enzymes.

Within the pharmaceutical sector, protein-based biopharmaceuticals constitute 8 out of the 10-bestselling products, and the global protein-based biopharmaceutical market had sales worth $120b in 2017. A major component of the manufacturing cost of these products is associated with extraction of the product from the host production cells, isolation and purification procedures.

This has a major impact upon the affordability and equitable global access to biologic-medicines once off patent, as the high manufacturing cost limits possible price reductions when compared to small-molecule generic medicines. As such, adoption of new methods to facilitate the isolation of high purity and quality product, would offer great benefit in reducing the cost and challenges, and hence benefit society.

Research applications

In the MIB we have extensive expertise in the development and application of expression platforms (from microbial hosts, yeasts, insect cells, mammalian cells) for the production of functional proteins, biopharmaceuticals and new modalities (including fusion proteins and viral vectors). We implement cell engineering (synthetic biology) and culture process optimisation (bioprocessing) approaches, in combination with bioanalytical characterisation, to clarify the fundamentals of cell biology that determine yield and quality of expressed products.

The consequences of product structure for the production and quality are defined using computational and biophysical analysis, to generate predictive tools for the design of new protein entities and increased understanding of their stability and format (formulation) suitable in manufacture for potential therapeutic use.

These approaches seek to improve the success rate of innovator biotherapeutic products through pre-clinical and clinical trials, and to allow a reduction in the costs of goods of innovator and biosimilar biotherapeutic products to allow more equitable access to these advanced therapeutics.