A consortium has been announced by the Centre for Process Innovation (CPI) for the development of a novel analytical platform to improve the rapid analysis of the glycosylation profiles of biotherapeutics.
Collaboration
Bringing together the expertise and resources of the CPI, GlycoSeLect, ForteBio Pall Life Science and Allergan Biologics, the consortium aims to address the need for new glycoanalytical approaches to meet the needs of the growing biotherapeutics market (including novel molecules, biosimilars and biobetters).
Characterising the profile of glycosylation on biotherapeutics 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 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. Biotherapeutics manufacturer, Allergan, will play a critical role in evaluating the platform and demonstrating its value in the development of these important therapeutic products.
“CPI is delighted to be working with GlycoSeLect, ForteBio Pall Life Science and Allergan Biologics on this project which will develop a novel analytical approach to rapidly analyse an important quality parameter for biotherapeutic proteins,” said Dr John Liddell, senior scientific advisor, Centre for Process Innovation. “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.”
“GlycoSeLect is delighted to continue its collaborations with CPI including our partners in Allergan and ForteBio Pall,” added Robert Dunne, chief executive officer, GlycoSeLect. “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.”
“Allergan Biologics is excited to work with GlycoSeLect, 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,” commented Dr Andrew Brown, associate director, Process Sciences, Allergan Biologics. “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.”