Five minutes at CPhI North America with
Erin O’Brien, Senior Director, Product Management, Vial Containment & Delivery, West Pharmaceutical Services, Inc.
PH: First of all, please tell me us about West.
O’Brien: We are a world leader in the integrated containment and delivery of injectable drugs and healthcare products; the top 50 injectable biologics globally rely on products fromWest and our partner Daikyo, and we make 40 billion components annually. In recent years, we have expanded our product offerings to more complex delivery devices. We are a global operation, with 28 manufacturing sites and 50 locations, all working with customers to solve some of their toughest packaging challenges.
PH: Are you launching any innovations here?
O’Brien: There are a number of things we are showcasing at CPhI North America. The SmartDose® platform has been getting a lot of publicity of late –it is a novel wearable, subcutaneous injector with an integrated drug delivery system that incorporates human factors and usability testing to deliver a truly patient-centric approach to self-administration.. The SmartDose platform can help delivering drugs that have to be dosed at a higher volume (up to 10 mL) where a traditional injection would not suffice, or which have a high viscosity and would be painful for the patient if delivered through a standard injection.
PH: Is it in commercial use already?
O’Brien: In July 2016, Amgen announced FDA approval for a single, monthly 420 mg dose delivery option for Repatha® (evolocumab), utilizing the SmartDose technology What’s really exciting is thatthe SmartDose platform is an integrated solution for delivery and containment featuring West’s silicone-free Daikyo Crystal Zenith® cartridge and a West FluroTec® coated piston containment system.
PH: What else are you showcasing?
O’Brien: LyoSeal® cap is an advance in closure systems for lyophilised drugs in particular. In typical lyophilisation, the stopper is placed in the vial in an ‘up’ position to enable the freeze-drying to take place, then, in a subsequent processing step, the vial is capped outside the lyo chamber in another unit operation. The beauty of LyoSeal cap is that it simplifies the process: the stopper is placed in a plastic cap and during lyophilisation, at the end of the cycle, the chamber is compressed. That closes the stopper and also seals the vial, so there is no need for a subsequent aluminium seal. There is also an immediate safety benefit and a reduced risk of glass breakage.
PH: What prompted you to work on innovations like these?
O’Brien: We take a market-led approach to understanding our customers’ needs. In biologics, the complexity of the drug product is driving the need for new delivery systems, novel containment systems and high quality elastomers like our NovaPure brand. The drug chooses the packaging, so there are still many areas where glass is still safely used, but others where it poses challenges around delamination, or where drugs with a high pH require a different environment to be delivered stably and safely and this is where engineered polymers such as COP can stand out. The rise of cell therapy and gene therapy and the need for these products to survive more extreme storage conditions means that the containment system is critical and Crystal Zenith containers have a very bright future in those areas.