Case study: Challenges in manufacturing high value lyophilised oncology drugs
A B S T R A C T
A complete integrated freeze-drying system designed for high value anticancer products consisting of a reduced foot-print freeze dryer with an innovative loading/unloading system, integrating a steam-sterilizable slider with no concealed parts which is moved by a contact-free magnetic drive mechanism. This innovative system enables the transfer device, or ‘slider’, to remain inside the chamber to undergo cleaning and sterilization in place along with the internals of the freeze dryer.
Integrated with process analytical technologies for pharmaceutical freeze-drying processes, including vacuum induced nucleation control that reduces the duration of the primary drying cycle and ensures the uniformity and homogenization of the vials in all the batches, respecting the product morphology and physiochemical properties. The system is completed with an automated inline vial management device able to reject, reintroduce and retrieve vials during loading / unloading process designed for automatic detection and treatment of vials in an automatic line.
The nature of the business and the products the pharmaceutical company manufacture require a high degree of flexibility and specialization. This article provides key information of the integrated solution designed in accordance with strict requirements of quality to remove risks in oncology manufacturing processes.
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