Injectables

Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.

In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.

Particles in parenteral drug products are a serious concern; they can cause issues such as product recalls, or worse, immunogenic responses. Sources of particles are varied; they can be from aggregates of biologic API’s, excipient contaminants, components, or silicone oil used to promote syringe function. With emphasis on safe and efficient delivery of drug products, West is focused on strategies to both measure particles, and mitigate their presence.

Injectable drug products have stringent requirements for the presence of visible particles. However, there is currently no regulatory guidance for visible particles related to packaging components. Instead, specifications are established between suppliers and customers.

West is pleased to announce that it has commenced discussions with Swissfillon AG, a provider of aseptic fill and finish services to pharmaceutical and biotechnology companies, that are intended to lead to a non-exclusive global collaboration to provide fill-finish capabilities to customers using West’s proprietary SmartDose drug delivery platform for complex molecules. West made the announcement at PharmaPack 2019, the annual conference for pharmaceutical packaging and drug delivery, held February 6-7 in Paris.

When you think of injectable medication, a classic image may include a set of hands holding both a vial and a syringe to withdraw medication prior to injection. Advances in both drug products and self-injection options – including auto-injectors, pens and other self-injection devices – have helped to draw a new picture for injectable delivery.