Earlier this month West Pharmaceutiucal Services reported its Q3 earnings and like the procession of financial reports before it spoke eagerly of potential sales of its CZ drug delivery system, expected by both the firm and analysts to boom around 2016 if it gets regulatory success.
Now the hope of commercialising this alternative to glass for biotech products has been slightly raised with the completion of a preliminary study of its CZ-integrated SmartDose technology platform.
This platform “enables subcutaneous delivery of a larger dose, which opens up opportunities for the effective delivery of biologics,” Graham Reynolds, VP of Marketing and Innovation, told this publication.
The CZ cartridge is the primary drug container, and allows the drug to be prefilled into the cartridge within the system, he added. “It has been shown that dimensional tolerances achievable with the Daikyo Crystal Zenith polymer are superior to glass, and this helps to optimize the system performance.”
As for industry, Reynolds told us of how the CZ has attracted the attention of many biologic firms, “driven by their own development of higher-concentration biologics, needing doses in excess of 1mL to be effective.”
Anticipation
West’s guidance for the sales of CZ sit around $14m for the year, though the firm has predicted this figure could leap to around $600m per quarter once commercialization begins.
Earlier this year, West began preparing for such scale-up by adding – through its fill-finish partner Vetter – a second filling line for the system.
However, West needs to drive commercial manufacturing and reduce its capital expenditure intensity of its production capacity, and thus regulatory approval will aid this – according to Jeffries analyst David Windley – on top of the additional significant revenue.