When changes are made to the the active pharmaceutical ingredient (API) or excipients (e.g. fillers, disintegrants, lubricants) of a Pfizer 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 Pfizer, 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 sugar 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, MCT ensures 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 many different techniques which 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 microscopes. 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 Pfizer medicines, whether they are newly launched or established products, are manufactured to expected standards and will perform consistently when they reach patients around the world.