Basis of the new vaccine formulation and analysis service are advanced, precise and highly informative analytical techniques.
The new service will be centred on XstalBio’s proprietary solid state Circular Dichroism (ssCD) capability alongside highly specialised orthogonal analytical techniques and an increased range of vaccine analysis, formulation and stability testing services.
This increased range is comprised of physico-chemical methodologies for vaccine characterization and release, formulation development and stability testing.
The company said that the Analytics vaccine service’s approach to vaccine analysis and formulation takes a holistic view, aimed at understanding the antigen-adjuvant interaction and the consequences for antigen structural integrity, potency and stability.
The new service, which brings these specialist techniques together, is designed to combine a comprehensive vaccine analysis capability with an effective solution to the currently unmet need to be able to directly analyse the biopharmaceutical antigen.
The ssCD analytical technique has the ability to determine specific aspects of structure in biopharmaceutical antigens in colloidal particulate vaccines.
The new service includes an array of techniques for vaccine analysis and characterization that are all fully compliant with ICH Q6B recommendations, which includes conformance with ICH Q6B’s spectroscopic characterization requirements for colloidal formulations that could not previously be analysed by usual techniques due to particle-induced artefacts.
In addition, XstalBio Analytics’ approach to stability studies is designed for regulatory compliance with ICHQ1A R2 and ICHQ1E for stability testing.
The new service will be provided from the company’s research centre in Glasgow and will be headed by Dr. Allan Watkinson, who was formerly with Avecia Vaccines (UK) and Pharmathene.
He has extensive experience in vaccine development, formulation, analytics, GMP manufacturing and stability.
Watkinson said that the use of cutting edge analytical technologies enables us to overcome many of the issues traditionally associated with the detailed structural analysis of colloidal vaccine formulations.
"Structural data can be obtained in situ without desorption of the antigen, enabling us to deliver an innovative approach to assist with vaccine formulation, characterisation and stability studies," Watkinson said.
"This, together with our experience and expertise in formulating vaccines, ensures we can deliver an unrivalled opportunity to accelerate the development of a customer’s vaccine candidate."
Image: The new XstalBio Analytics vaccine service will benefit biopharmaceutical and vaccine sectors. Photo: courtesy of XstalBio Ltd