SaniSure supports the full lifecycle of mAb production—from pre-clinical to clinical and commercial—including upstream, downstream, and final fill operations.

Maximizing Your mAb Production
SaniSure offers flexible, agile solutions to meet the unique demands of your small and large-scale monoclonal antibody (mAb) manufacturing processes.
How SaniSure Optimizes mAb Processes
From pre-clinical to clinical and commercial processes, SaniSure increases efficiency and reliability at every step, including: closed processing and process liquid transfer, intermediate mixing, storage and shipping, sampling solutions, vials for stability studies, release and retain samples, final filling needles and assemblies, and more.
SANISURE SOLUTIONS

An ideal solution for closed, small-volume mixing in GMP processing.
- Configurable design built from an extensive portfolio of proven features to precisely match your application requirements: media and buffer prep, process intermediate pools, UF/DF retentate vessel, bulk and final formulation, and more.
- Rigid mixing vessel ensures batch-to-batch repeatable mixing performance
- Easy and fast setup saves time
- Provides continuous mixing while draining for filling applications
- Exerts 2x lower shear forces than comparable bag mixing systems.

Compact, closed and easy-to-use solution for sterile, multiple-bottle filling in GMP processing that’s adaptable to your needs.
- Streamlines intermediate, bulk and reagent filling operations during mAb manufacturing
- Enables 10x faster filling than individual filling and 40-second setup
- Delivers +/- 3% filling accuracy
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With outstandingly clean and strong Pharmatainers, our ready-to-use bottle assemblies simplify your sterile manufacturing for applications in USP, DSP and liquid or frozen bulk storage and shipping.
- Produced with ADCF virgin medical-grade resins in an ISO 5-classified environment
- Extremely low particulates, endotoxin and extractables
- Extensive qualification, testing and documentation simplifies regulatory compliance
- Individual bottle traceability with serial number, lot number and expiration date
- Available from 10 mL to 20 L in PET or PC

Custom, configurable and best-in-class assemblies to optimize your biomanufacturing processes.
- Fully configurable with a vast library of components and tubing from SaniSure and other leading suppliers
- Unmatched expertise for design, development and supply of custom fluid management solutions
- Proven and efficient 6-step design-to-delivery process

Simple, secure, configurable sampling solution that draws up to 10 samples simultaneously with a single connection.
- Configurable with a wide variety of container types, materials and volumes.
- Draw up to 10 samples simultaneously with a single sterile connection
- A single, simple and reliable sterile connection reduces risk of process contamination by up to 10X versus single sampling.

Bespoke final-fill assemblies designed entirely around your drug product.
- Dedicated final-fill design experts follow the process from initial concept to operational support
- Vertical integration of filling needles, pump tubing and overmolding ensures seamless project execution
- Integration with Mixed4Sure formulation vessel, PUPSIT assembly, multiple beta port and surge vessel options provides a complete solution
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See how our industry leading solutions can optimize your mAb manufacturing flow paths.