Innovative New Vaccine Analysis Service Launched By XstalBio
Advanced, precise and highly informative analytical techniques are the basis of a specialist new vaccine formulation and analysis service introduced for the biopharmaceuticals sector.
The new XstalBio Analytics vaccine 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.
This increased range includes physico-chemical methodologies for vaccine characterisation and release, formulation development and stability testing. 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 currently unmet need to be able to directly analyse the biopharmaceutical antigen whilst it is bound to its particulate adjuvant.
The ssCD analytical technique is unique in its ability to determine specific aspects of structure in biopharmaceutical antigens in colloidal particulate vaccines. For the first time, the specialist ssCD analysis developed by XstalBio allows the collection of in situ CD spectra in colloidal suspensions and enables structural data on bound antigens to be provided, making the service ideal for vaccine protein antigen analysis.
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. Dr Watkinson was formerly with Avecia Vaccines (UK) and Pharmathene Inc, Dr. Watkinson 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.”
XstalBio is a privately held formulation and drug delivery company with proprietary technologies for the effective delivery of biologics by injection, inhalation, oral and nasal routes.
As biopharmaceuticals have increasingly taken on colloidal formulations, XstalBio has been at the forefront of specialist new techniques that have overcome the analytical issues associated with this change and led an increased understanding of colloidal biopharmaceuticals and particulate vaccines. For more information, visit www.xstalbio.com/xstalbio-analytics
XstalBio specialises in delivering value-added solutions to clients and partners' needs and has successfully formulated over 40 biopharmaceuticals working with many of the world's top pharmaceutical and biotechnology companies, including the vaccine and animal health sectors. In conjunction with this formulation expertise, XstalBio has been in the forefront of analytical development specifically for colloidal biopharmaceuticals and especially vaccines.