The Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing and a part of the High Value Manufacturing Catapult, today announced a collaboration to develop a novel analytical platform to improve the rapid analysis of the glycosylation profiles of biotherapeutics. This is a critical quality attribute which is important for the efficacy and safety of these molecules. The consortium brings together the expertise and resources of CPI, GlycoSeLect UK Ltd, ForteBio Pall Life Science and Allergan Biologics Ltd, to address the need for new glycoanalytical approaches to meet the needs of the growing biotherapeutics market (including novel molecules, biosimilars and biobetters).

Biotherapeutics have been shown to be highly effective in the treatment of diseases ranging from cancer to rheumatoid arthritis. More than two-thirds of biotherapeutics are glycosylated proteins which includes the therapeutically important category of monoclonal antibodies. However, the development and manufacture of these potentially life-changing treatments carries a high risk of failure, is technically challenging and expensive.

Characterising the profile of glycosylation on these molecules is a key product quality attribute of a glycosylated proteins, and is important in delivering an efficacious product to the patient. This project, which will be hosted at CPI’s state-of-the-art facilities at the National Biologics Manufacturing Centre, uses GlycoSeLect’s glycosylation recognition technology and ForteBio Pall’s biosensor-based analytical platform technology to create a novel glycoanalytical platform. The platform will enable simplified, rapid, high-throughput and cost-effective characterisation and monitoring of the product throughout the development and manufacturing processes. Allergan, a leading biotherapeutics manufacturer, will play a critical role in evaluating the platform and demonstrating its value in the development of these important therapeutic products.

The new glycoanalytical platform will produce a credible alternative to current liquid chromatography and mass spectrometry-based methods for biopharmaceutical companies and CMOs/CROs during product development, characterisation and manufacturing. The innovative platform will reduce costs and accelerate product development pipelines, enabling greater process monitoring and helping to reduce the risk of failure in development and manufacture.

“CPI is delighted to be working with GlycoSeLect UK Ltd, ForteBio Pall Life Science and Allergan Biologics Ltd on this project which will develop a novel analytical approach to rapidly analyse an important quality parameter for biotherapeutic proteins. Developing a simple, rapid and high throughput glycoanalytical method moves us further along the path to streamline development and manufacture of biotherapeutic proteins contributing to lower costs and faster development” said Dr John Liddell, Senior Scientific Advisor, Centre for Process Innovation.

 “GlycoSeLect is delighted to continue its collaborations with CPI including our partners in Allergan and ForteBio Pall.  This project will validate our RPL technology as a first pass, efficient and cost-effective analytical tool for the characterisation of biotherapeutics increasing the efficiency of their development as efficacious products” said Robert Dunne, Chief Executive Officer, GlycoSeLect.

“Allergan Biologics Ltd is excited to work with GlycoSeLect UK Ltd, ForteBio Pall Life Science and CPI to explore a new avenue for the rapid assessment of product glycoforms when developing and manufacturing biopharmaceutical manufacturing processes. Variation in glycoform typically has a significant impact on the efficacy of a biological product. This technology has the potential to facilitate greater process understanding to help develop robust manufacturing process, which in turn supports the delivery of innovative new treatments to patients” said Dr Andrew Brown, Associate Director, Process Sciences, Allergan Biologics.