The technology – which is suitable for both clinical and commercial-scale drug production – was developed by French contract manufacturing organisation (CMO) Disposable-Lab (D-Lab), which partnered with ATMI to commercialize the platform earlier this week.
ATMI told in-Pharmatechnologist.com that: “[The tech] s the only fill /finish platform made from all single-use components, including everything from the needle to the isolator,” explaining it is made from TK8 plastic film, which is validated for current good manufacturing practices (cGMP) environments.
The firm claims the system will cost manufacturers “three to five times less a classical filling line” and that “operational costs are up to two times less” and also said that "the set-up and validation of the SUT fill/finish line is about 6 months, versus 2-3 years for a traditional filling line.”
“Disposable-Lab will continue to use the technology to manufacture clinical materials for customers as part of their CMO services,” ATMI continued, adding that its role in the partnership will be to “offer the platform for sale and application at customer sites."
“Both ATMI and D-Lab will provide application support when these lines are installed at pharmaceutical customers or other CMO’s.”
The system – as its single-use, disposable moniker implies – is designed to fill and finish just one product batch after which it needs to be binned.
Just out of curiosity in-pharmatechnologist.com wondered how CMOs and drugmakers that buy the platform should go about disposing of it when they are done and – according to ATMI – the process is straightforward.
“The disposable components are treated like any other type of single-use waste, such as storage bags. Some methods include incineration, and others include recycling,” adding that “While there are more resources for this being introduced to the market, ATMI does not specifically offer a recycle service.”
Single-use drug manufacturing technologies are increasingly important for ATMI. In February, the US firm reported that continued demand for such products drove the 20% increase in revenue – to $10.9m (€m) – seen in its life sciences business in the fourth quarter.
This increase, which continued the revenue growth seen by ATMI’s life sciences business in the two previous quarters, is part of a trend CEO Doug Neugold expects to continue in 2013.
”In life sciences, while there is uncertainty in the timing associated with ramping a new technology, we believe growth should be within our long-term expectations as customers to ramp manufacturing processes incorporating our single-use mixing and bioreactor systems."