XstalBio Analytics has announced a vaccine analysis and formulation services that uses a proprietary solid-state circular dichroism (ssCD) capability; specialized orthogonal analytical techniques; and an increased range of vaccine analysis, formulation, and stability testing services, according to a company statement. The increased range includes physico-chemical methodologies for vaccine characterization 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.
The ssCD analytical technique can determine specific aspects of structure in biopharmaceutical antigens in colloidal particulate vaccines. 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 suitable for vaccine protein antigen analysis.
The service incorporates techniques for vaccine analysis and characterization that are compliant with ICH Q6B recommendations. The company reports that its 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 research center in Glasgow, Scotland and will be headed by Dr. Allan Watkinson.
Source: XstalBio Analytics