New Monoclonal Antibody cGMP Development and Support Service
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FUJIFILM Diosynth Biotechnologies, a leading global biologics Contract Development and Manufacturing Organization (CDMO), has announced the expansion of its Monoclonal Antibody development and manufacturing services with the introduction of its Saturn mAb Platform™.
The Saturn mAb Platform™ is the result of the application of years of experience developing and optimizing monoclonal antibodies processes with efficient cGMP production and batch disposition. It is also an extension of FUJIFILM Diosynth Biotechnologies’ experience gained while developing and subsequently implementing its Apollo™ Mammalian Expression Platform. Apollo™ was developed for robust, high levels of recombinant protein expression with manufacturability for the entire life of a customer’s product as the end goal.
“Saturn mAb is intended to be a platform that customers can feel confident will take their candidate to the clinic quickly,” said Martin Meeson, president, FUJIFILM Diosynth Biotechnologies, U.S.A. “Support of late phase production and eventually commercial launch was built in the offering to make Saturn a platform for life.”
The Saturn mAb Platform™ is designed to enable rapid access to manufacturing capacity. It offers options and flexibility as it was designed to be an extension of the ApolloTM mammalian expression platform for customers who need full gene to GMP services. It also supports processes established with customers’ existing cell lines. “It incorporates the best-in-class single use technologies in all upstream and downstream units of operation”, said Andy Topping, chief scientific officer, FUJIFILM Diosynth Biotechnologies. “This platform was designed for reliability of manufacturing.”
This article has been republished from materials provided by FUJIFILM Diosynth Biotechnologies. Note: material may have been edited for length and content. For further information, please contact the cited source.