Date: 2013-04-12
Type of information: Commercialisation agreement
Compound: all-single-use fill/finish platform
Company: ATMI (USA) Disposable Labs (France)
Therapeutic area: Technology - Services
Type agreement: commercialisation
Action mechanism: The fill/finish platform is modeled 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.
Disease:
Details: ATMI, a global technology company and a leader in single-use process solutions, has announced that it 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 solution is offered by ATMI LifeSciences through an exclusive agreement with France -based Disposable-Lab, S.A.S., a clinical filling services and contract manufacturing organization (CMO). 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 and Disposable-Lab will jointly commercialize the technology. 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.
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