ATMI
ATMI LifeSciences has introduced an all-single-use fill/finish platform for pharmaceutical and biopharmaceutical applications that is compliant with current cGMPs. The platform is designed for bioprocess applications from clinical batch to industrial scale, with fills ranging from 0.2 ml to 100 l. This solution is offered by ATMI LifeSciences through an exclusive agreement with France-based Disposable-Lab, S.A.S., a clinical filling services provider and CMO. ATMI LifeSciences and Disposable-Lab will jointly commercialise the technology.
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 minimises 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,” noted Senior Vice President and General Manager of ATMI LifeSciences Mario Philips. “As innovators ourselves, we saw a great deal of potential in Disposable-Lab’s technology. 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 LifeSciences initially engaged with Disposable-Lab in 2008 as a minority investor and later acquired the full rights to the company’s 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.
ATMI LifeSciences, +32 2 264 1877, nvertommen@atmi.com, www.atmi.com.