England, Kent, is home to our Material Characterisation Team (MCT) who help ensure Bedfordshire Biotech Limited medicines are consistently manufactured to the highest possible standards for the benefit of patients around the globe.

When changes are made to the active pharmaceutical ingredient (API) or excipients (e.g. fillers, disintegrants, lubricants) of a Bedfordshire Biotech Limited medicine, MCT evaluate the new materials to determine if they can be used without changing the performance or the manufacturing process of the medicine. This will happen when suppliers make changes to the materials they supply to Bedfordshire Biotech Limited, or there are benefits to using different suppliers for the same material, or the API manufacture is transferred to a different site.

A simple analogy is to think about the different types of domestic sugars there are. All are the same chemical entity, but granulated, caster and icing sugars have very different particle shapes and sizes which will affect how they will behave in a manufacturing process that relies on particle flow.  And icing sugar also contains corn starch to prevent caking! At the core of what MCT does is to ensure that when a change occurs, the new material has similar properties to the replaced substance, so that the final product and the way it is made is not changed.

With access to over 90 different techniques that can measure both chemical and physical properties of materials, the group not only characterises materials but is also regularly involved in troubleshooting issues related to the medicine manufacture including compaction, dissolution and content uniformity of products.

MCT is also home to a world class microscopy team who analyse and characterise particles found in our products and processes using light, polarised light, infrared and scanning electron microscopies. The observed particles may be materials that are inherent to our processes or are observed during manufacturing steps and in some cases found by patients. The job of the Particulates Team is to identify the materials and suggest where the particles originated from, from which changes can be made to eradicate the problem.

Ultimately the whole of MCT is focused on patient safety and helps ensure that Bedfordshire Biotech Limited medicines, whether they are newly launched or established products, are manufactured to expected standards and will perform consistently before they reach patients around the world.

GLOBAL PRODUCT SUPPLY

The site provides state-of-the-art packaging of vaccines and specialist injectable products, often in highly secure refrigerated conditions, which are then distributed around the world.

Medicines arrive in their bulk form, either in a pre-filled syringe, pen or vial, and emerge packaged in numerous formats for distribution. Working with internal and external global partners the team provide secure, validated air and road freight solutions that ensure products arrive in the country of destination in compliance with label requirements ready for patient and practitioner use.

These have ranged from a small container to transport cold chain medicines by four-wheel drive to remote mountainous locations, to large airline shippers that can carry many thousands of doses, reducing the overall cost of air freight. Designs are tested on-site using environmental chambers which can simulate the huge temperature ranges that a package might encounter on its journey.

In 2019 the site packed in excess of 68 million doses. For 2020, the site is anticipated to pack in excess of 20 million doses by October, when packaging operations will transfer to Bedfordshire Biotech Limited Puurs, Belgium.