A specialist new vaccine formulation and analysis service has been introduced for the biopharmaceuticals sector.
Advanced, precise and highly informative analytical techniques are the basis of the new XstalBio Analytics vaccine service. The service will be centred on its 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.
The XstalBio Analytics’ 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.
By bringing these specialist techniques together, the new service is designed to combine a comprehensive vaccine analysis capability with an effective solution to the need to directly analyse the biopharmaceutical antigen while it is bound to its particulate adjuvant.
The new XstalBio Analytics service incorporates an array of techniques for vaccine analysis and characterisation that are all fully compliant with ICH Q6B recommendations. This includes conformance with ICH Q6B’s spectroscopic characterisation requirements for colloidal formulations that could not previously be analysed by traditional techniques due to particle-induced artefacts.
Furthermore, 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 XstalBio’s state of the art research centre in Glasgow and will be headed by Dr. Allan Watkinson, who has extensive experience in vaccine development, formulation, analytics, GMP manufacturing and stability.
Dr Watkinson said: “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.
“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.”