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    Clinical batch manufacturing for high-value products

    Reduce product loss when filling small batches of high-cost drugs. 

    Connect with experts Download Versynta flyer

    Maximize yield in clinical batch manufacturing for high-value drugs

    Clinical batch manufacturing of high-value biotech drugs demands precise low-volume filling and in many cases frequent format changes. Limited API supply and strict aseptic controls can turn routine set-ups into a high-risk event.

    Control cost, changeovers and risk in clinical batch manufacturing

    How to reduce product loss in clinical batch manufacturing?

    Versynta lines reduce loss on high-value small and micro-batches.

    How to shorten changeovers between small clinical batches?

    Versynta platforms cut format and product changeover time.

    How to ensure aseptic integrity in small clinical batches?

    Gloveless automated cells protect aseptic filling of each batch.

    Compare Versynta small and micro batch solutions

    Overall 2 Solutions
    Output performance
    Format range
    Special features
    Changeover
    Container types
    Barrier technologies and line integration
    Benefits
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    Versynta microBatch
    Output performance
    Up to 450 containers/h
    Format range
    RTU vials 2R-50R, syringes 0.5-20 ml, cartridges 1-10 ml
    Special features
    Gloveless robotic workcell
    Changeover
    Batch changeover around 2h
    Container types
    RTU vials, syringes, cartridges
    Barrier technologies and line integration
    Gloveless isolator workcell
    Benefits

    Best if you want:

    • Fully automated, gloveless robotic workcell
    • Clinical trials or cell and gene therapy
    • 100 percent IPC and flexibility at its core
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    Versynta FFP
    Output performance
    Up to 3,600 containers/h
    Format range
    Vials 2R-50R, syringes/cartridges 0.5-10 ml
    Special features
    Modular platform
    Changeover
    Changeover by size parts only
    Container types
    RTU vials, syringes, cartridges
    Barrier technologies and line integration
    Machine isolator one unit
    Benefits

    Best if you want:

    • Small batch filling line with 100 percent IPC and flexibility at its core
    • One modular platform for RTU vials, syringes and cartridges
    Featured_Download_Teaser_smallBatch

    See Versynta options for clinical and small batch filling

    Get a compact overview of Syntegon small batch filling solutions.

    •  See output per container type 
    •  Review (gloveless) isolator concept 
    •  Assess changeover effort
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    Clinical batch manufacturing features in the Versynta portfolio

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    Fully automated small batch isolator lines
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    Integrated air management for compact isolators
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    100% IPC across all container types

    Your strategic lifecycle partner for Clinical batch manufacturing

    service-life-cycle
    Ready for everything – from project start to routine production

    From line installation to production optimization, Syntegon supports you with structured service packages, training, and specialists – for safe, stable, and resilient production across the lifecycle. 

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    service-life-uptime
    Secure availability – every day

    Fast spare parts, qualified support, and preventive maintenance help you avoid unplanned downtime, protect performance, and keep daily operations reliable.

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    service-life-cycle
    Make your line fit for tomorrow

    Scalable retrofits and data solutions help you adapt to new demands, improve OEE, and keep your lines future-proof across changing requirements.

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    Clinical batch manufacturing knowledge hub

    Versynta FFP flyer
    Versynta FFP flyer

    Get an overview of the modular FFP platform.

    Download
    Versynta microBatch flyer
    Versynta microBatch flyer

    Explore the fully automated gloveless microBatch workcell for RTU containers.

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    Versynta small batch portfolio overview
    Versynta small batch portfolio overview

    Review Syntegon small and micro batch solutions in one go.

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    Frequently asked questions

    In the Versynta context, clinical batch manufacturing means the production of small and micro batches of high value biotech drugs. The portfolio combines highly automated filling and integrated isolator concepts. It targets precise, repeatable processing for clinical trial batches and clinical sample runs.

    See Versynta filling systems

    Versynta microBatch suits the smallest clinical batches with fully automated gloveless processing of RTU vials, syringes and cartridges at up to 450 containers per hour. It targets clinical trials, cell and gene therapy and personalized medicine. Versynta FFP covers small outputs up to 3,600 containers per hour on one platform for RTU syringes, vials and cartridges.

    Compare FFP and microBatch

    Versynta microBatch uses a gloveless isolator workcell with integrated air management and no interface to the building system. This prepares the workcell for aseptic production with short bio decontamination times. Versynta FFP integrates machine and isolator as one unit with integrated air management and a flexible pressure and zone concept for aseptic and aseptic potent production.

    See isolator and barrier systems

    Versynta FFP handles nested RTU vials from 2R to 50R for liquid or lyo applications as well as syringes and cartridges from 0.5 to 10 ml. Versynta microBatch processes RTU vials from 2R to 50R, cartridges from 1 to 10 ml and nested syringes from 0.5 to 20 ml.

    View FFP and microBatch technical data

    Versynta microBatch uses a standardized workcell that achieves complete batch-to-batch changeover in around 2 hours, which fits frequent product changes in clinical trials. Versynta FFP uses changeover by size parts only without module change. This reduces setup work and keeps format changes lean so downtime between batches stays low.

    Versynta FFP provides integration with Syntegon freeze dryers. The solution features a linear vial transfer, enabling direct and efficient row-by-row loading, and is compatible with a wide portfolio of unique systems such as LyoGistics Zero, offering fully bellows-free and cold shelf loading capability.

    Read about freeze dryer
    Interested in our small batch portfolio?

    Interested in our small batch portfolio?

    Reach out to our experts.

    Are you looking for advice on our small batch portfolio or do you have a specific project in mind? Get in touch with our experts.
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