ATMI Inc., a global technology company and a leader in single-use process solutions, has introduced the first all-single-use fill/ finish platform for pharmaceutical and biopharmaceutical applications that is compliant with current good manufacturing practices (cGMP).
The platform is designed for bioprocess applications from clinical batch to industrial scale, with fills ranging from 0.2 milliliters to 100 liters. This unique solution is offered by ATMI LifeSciences through an exclusive agreement with France-based Disposable-Lab, SAS, a clinical filling services and contract manufacturing organisation (CMO).
ATMI and Disposable-Lab will jointly commercialise the technology. The fill/ finish platform will be on display at the upcoming INTERPHEX trade show in New York being held from April 23 to 25.
The disposable platform is modelled after traditional manufacturing fill/ finish processes, but on a much smaller scale. All of the process equipment used in conjunction with the fill/ finish platform is disposable, including the connectors, vials, baskets and caps, to form a completely disposable process equipment platform. As such, the platform minimizes maintenance costs and provides a smaller footprint versus traditional systems. The easier to use format also delivers time savings during setup and operation.
“This is the only platform of its kind on the market, and it is an excellent fit for our single-use product portfolio,” said Mario Philips, senior vice president and general manager of ATMI LifeSciences. “As innovators ourselves, we saw a great deal of potential in Disposable-Lab’s technology. Customers will benefit from having access to the disposable fill/ finish platform, as well as from our collaboration. When combined with the mixing system, bioreactor and vessel offers we already have in place, this new addition allows us to provide customers with a truly comprehensive range of single-use technology solutions.”
Operation of the platform involves decontaminating the non-disposable box in/ flushing isolator with hydrogen peroxide. The vial baskets are then manually placed in the preparation isolator before the vials are filled using disposable dispensing needles in the transfer area. Weighing and capping operations are performed in a sterile finishing isolator, where the vials are closed in one step prior to weighing.
ATMI initially engaged with Disposable-Lab in 2008 as a minority investor and later acquired the full rights to their fill/ finish platform. The platform is available in two formats. Customers can opt for installation via the technology transfer format, or they may outsource their clinical batches using the Disposable-Lab CMO service capability.