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The European medicines regulatory system is based on a network of around 50 regulatory authorities from 30 EEA (European Economic Area) countries (27 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and the EMA (European Medicines Agency). For a medicinal product to be available on the market it needs to have a marketing authorisation. The marketing authorisation application (MAA) must provide evidence of the efficacy, safety and quality of the medicine. When applying for a marketing authorisation for a medicine, the marketing authorisation application is submitted to a regulatory authority, which will assess the medicinal product’s pharmaceutical and chemical quality, efficacy and safety, as well as its risk-benefit ratio.

Cell and gene therapies are an expanding area with an expected growth rate of 24.7% over the forecast period of 2022-2030 .¹
Vial-stopper-seal combinations used as containment systems for these therapies need to maintain container closure integrity (CCI) for extended periods. Achieving CCI can be a particular challenge due to the low storage temperatures required: ultra-low (-80°C) for gene therapies and cryogenic (≤ -130°C, i.e., vapor of liquid nitrogen) for cell therapies.

I’m coming towards the end of my 19th year at West in May this year. Today, I am the Global Facility Energy Manager, working as part of the Global Facility Engineering team. Previously, I joined the West Dublin site as a Maintenance Technician and after two years I was promoted to Facilities and Maintenance Manager.

Mitigate risk of contamination, enable accurate dosing, while maintaining the stability and sterility of parenteral products

In the pharmaceutical industry, safety and quality are paramount. One critical aspect of ensuring the safety of pharmaceutical products is extractables and leachables (E&L) testing. This testing process examines the potential migration of substances from containers, packaging materials, and drug delivery systems into the drug products themselves. By understanding the reasoning behind E&L testing, we can appreciate its role in protecting public health and enhancing customer trust. West Pharmaceutical Services, Inc. is a leader in developing comprehensive studies to evaluate container closure systems in real world simulations, providing customers with a better understanding of their leachable profile and how that could affect drug stability.

The traditional way to package injectable drugs is to place them in a stoppered vial. The stopper is typically held in place with an aluminum ferrule that is called a seal. The vial seal is crimped onto the vial and not only serves to keep the stopper secured to the vial and the vial contents sterileⁱ but also protects the injection site on the stopper and provides a means of demonstrating lack of tampering.