Single Use Support GmbH: New Scalable Single Use Platform for Bulk Drug Substance FREEZE/SHIP/THAW Processes Based on Bags

Single Use Support GmbH: New Scalable Single Use Platform for Bulk Drug Substance FREEZE/SHIP/THAW Processes Based on Bags

04/04/2019, 10:00 AM - 10:45 AM

Javits Conventions Center - INNOPHEX Stage - Booth 3941
Language:
English
The challenges in handling of Bulk Drug Substance are enormous, since industry is looking for a scalable platform and affordable, robust solutions. Biopharmaceutical manufacturers produce API`s in different volume ranges and the sensitivity of these proteins to temperature and freeze/thaw varies. Also, the distance of the DSP site to F&F is a variable and along with the storage temperature. As a result, a lot of aspects need to be considered when designing and setting up processes for this high value stream. Single Use Support developed an end-to-end platform for this process based on Single Use bags. It starts with an integrity test and serialization of the bag, a robust shell that guarantees 0 product loss, a filling machine, freeze/thaw equipment, storage and shipping containers, and end-to-end track & trace solution. (GAMP 5 ready) A case study will be shown, how the product line reduces storage density, reduces product loss to zero and guarantees a smooth scale up from 10ml towards 300L. THE SOLUTION IS CALLED BULK.STREAM

Contributors

  • Johannes Kirchmair

    Speaker

    CEO / Founder

    Single Use Support GmbH

    Johannes Kirchmair spent 15 years in the Single Use Industry as a Process and Business Development Manager. As part of BPSA, ASTM, and Dechema...

Type of Session

  1. Type of Session
    Session

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