Case Study: The relief through customized manifolds

micheal-eder

Michael Eder

May 5, 2021

Table of contents

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  • How modularity enables flexibility
  • Finding the right Single Use Assemblies for Fluid Management

    Without a doubt automated filling drug substance into single use bags will be the future in Biomanufacturing industry due to its efficiency and its approach towards sterility. However, single use assemblies for automated filling platforms lack flexibility once clients have special requirements or may go different ways.

    One global life-science company consults biopharmaceutical companies in finding the right setup for tubings, manifolds, sterile connectors and all kinds of sterile consumables and often face challenges in provision of the applicable solution. In one scenario, one CMO opted for commercialized automated filling of small bags with a volume of 500ml. There were 1000 bags to fill per batch.

    Case Study - Customized Manifolds

    Without a doubt automated filling drug substance into single use bags will be the future in Biomanufacturing industry due to its efficiency and its approach towards sterility. However, single use assemblies for automated filling platforms lack flexibility once clients have special requirements or may go different ways.

    Challenges of market supply for sterile consumables

    None of the single use manifold assemblies matched the requirements of the CMO. The supply of manifolds was solely standardized and had no option on customized requirements.

    No room to adapt

    With the possible options to date, it was only possible to fill 20 bags of 500ml per run – making it very inefficient and expensive with 50 runs and required single use manifolds until 1000 bags have been filled.

    Delivery times

    The pandemic in 2020 and its fueled stockpiling involved also had an impact on lifescience consumables. All of a sudden single use manifolds had longer lead times discouraging manufacturers in being dependent on single use products with lacking flexibility and availability.

    Incompatibilies

    The insecurity is aggravated by the fact that some single use manifolds are primarily made to fit only on selected filling platforms. The compatibilities
    of manifolds to other platforms increased the dependency further and intensified the limitation of available manifolds on the market.

    How modularity enables flexibility

    Get to know the outcome of the case study and learn how modularity of different sterile consumables makes it easier to adapt to different scenarios while maintaining the fluid management at high sterility in a closed system.

    Case Study - Customized Manifolds

    Without a doubt automated filling drug substance into single use bags will be the future in Biomanufacturing industry due to its efficiency and its approach towards sterility. However, single use assemblies for automated filling platforms lack flexibility once clients have special requirements or may go different ways.
    micheal-eder

    Michael Eder

    Senior Marketing Manager

    Michael Eder, MA, is Senior Marketing Manager at Single Use Support. He is expert in pharma and health communication with his 10+ years experience in pharma. After completing his master's degree in International Healthcare Management at MCI The Entrepreneurial school in Innsbruck, he has gained experience in the pharmaceutical field manufacturing and commercialization of OTC and RX drugs. Michael creates articles about Freeze Thaw applications and Platform solutions from Single Use Support and is the author of current news with Single Use Support worldwide. 

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