New Platform to Accelerate the Delivery of Biotherapeutics

Pharmaceutical Technology's In the Lab eNewsletter

In the Lab eNewsletter, Pharmaceutical Technology\'s In the Lab eNewsletter-01-10-2018, Volume 13, Issue 1

The Centre for Process Innovation, GlycoSeLect UK, ForteBio Pall Life Science, and Allergan Biologics will collaborate to develop a novel analytical platform to improve the rapid analysis of the glycosylation profiles of biotherapeutics.

On Jan. 3, 2018, The Centre for Process Innovation (CPI), announced a collaboration with GlycoSeLect UK, ForteBio Pall Life Science, and Allergan Biologics to develop a novel analytical platform to improve the rapid analysis of the glycosylation profiles of biotherapeutics.

The collaboration will aim to address the need for new glycoanalytical approaches to meet requirements of the current biotherapeutics market, including novel molecules, biosimilars, and biobetters. The new glycoanalytical platform will produce an alternative to current liquid chromatography and mass spectrometry-based methods for biopharmaceutical companies, contract manufacturers, and contract researchers during product development, characterization, and manufacturing.

Characterizing the profile of glycosylation on these molecules is a crucial product quality feature of a glycosylated protein, and is important in delivering an effective product to the patient. The project, which will take place at CPI’s facilities at the National Biologics Manufacturing Centre in Darlington, England, uses GlycoSeLect’s glycosylation recognition technology and ForteBio Pall’s biosensor-based analytical platform technology to create a new glycoanalytical platform. According to a press release from CPI, the goal of the platform will be to support streamlined, rapid, high-throughput, and economical characterization and monitoring of products throughout the development and manufacturing processes. Allergan, a biotherapeutics manufacturer, will evaluate the platform for its significance in the development of these therapeutic products.

Biotherapeutics have been used in the treatment for a range of diseases, including cancer and rheumatoid arthritis. More than two-thirds of biotherapeutics are glycosylated proteins, which includes monoclonal antibodies, according to CPI. However, the development and manufacture of these treatments carries a high risk of failure.

“CPI is delighted to be working with GlycoSeLect UK, ForteBio Pall Life Science, and Allergan Biologics on this project, which will develop a novel analytical approach to rapidly analyze 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 at CPI, in the company press release.

Source: CPI