Biosimilar Development

The development of biosimilars is growing extremely rapidly with an annual growth rate of ca. 30% . At the heart of this growth in development is a comprehensive analytical data package to demonstrate that there are no clinically meaningful differences between the biosimilar product and the originator product in terms of safety, purity, and potency. Discover how we can help you to streamline this complex process.

iQue3®️ Advanced Flow Cytometry Platform

Meet the iQue3 - the most advanced flow cytometry platform with a focus on speed - from setup, to acquisition, and analysis - to get you from samples to actionable results in record time. The iQue3 combines a patented sampling method which allows for the fastest sample acquisition in the industry. It has the ability to handle 96, 384, or 1536 well plates, and enables continuous plate loading through connection with any automation system.

Discover the fastest path to actionable results with the iQue platform:

  • Multiplexed binding assays (96-well plate in 5 min)
  • Identify targets in their native conformation
  • Evaluate specificity and species cross-reactivity in the same well
  • Get information on cell health, isotype and titer from a single assay


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Binding Assays for Comparative Studies

Using live cells is a much more biologically relevant way of modeling surface receptor activity.

Editorial Article: From Whole Well to Single Cell – Enhancing the Development of Cancer Biosimilars with Advanced Flow Cytometry 

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Cy-Clone™️ PLUS Assay Kit for Ranking and Selecting Production...

Select your clones faster. Measure IgG secretion, cell number, and cell viability, and correlate these measurements - all in one assay.

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Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

The blockbuster success of antibody-based therapeutics for autoimmune diseases, inflammatory diseases and immuno-oncology accelerated the high stakes monoclonal antibody (mAb) development race. Clone selection is a significant upstream bottle-neck slowing bench-to-bedside development progress for new mAb-based therapeutics.

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Analytical Testing Is Crucial to Demonstrate the Level of Biosimilarity

Biosimilar Testing Services

Our Cell Line, Media and Testing Solutions (former Sartorius Stedim BioOutsource) expert scientists have extensive experience in biosimilar analysis and have developed a suite of off-the-shelf assay packages to support biosimilar comparability and characterization to complete similarity studies for a range of biosimilar molecules. The packages include cell based bioassays and assessments of binding kinetics, combined functional and physiochemical/structural analysis and an integrated biosimilar development service offering from DNA to Clinic.

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Cell Line Development

Find your antibody - secreting clone - fast

Are you working with a hard-to-purify protein and looking to set up production in a dedicated cell line? Our cell handling and analysis tools will make it a seamless, efficient process.

Bring your biosimilar products faster to the market with our unique solutions.

Webinar:

Body Feed Filtration – the Novel Method for Rapid Harvesting of Mammalian Cell Cultures

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Sartoclear Dynamics® Lab Kits for Cell Harvesting

Quickly and easily prepare your clarified supernatant with your target molecule with Sartoclear Dynamics® Lab, a simplified, small-scale mammalian cell harvest workflow to prepare samples of your antibody lead candidates for further analysis.

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Microsart® AMP Mycoplasma Kit

Mycoplasma are widespread contaminants in cell culture. Given their tiny size (~0.3-0.8 µm), mycoplasma cannot be visualized by microscopy. Cultivation-based detection takes 28 days, and even then, the colonies are difficult to visualize with the naked eye. Mycoplasma-contaminated products present a human health risk, so you must confirm your cell lines are uncontaminated.
Microsart® qPCR kits offer a safe and rapid method for early detection of mycoplasma contamination. It’s fast, highly specific and compliant with international guidelines.

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Rapid Sterility

Rapid bacteria detection in only 3 hours: validated Microsart®️ ATMP Bacteria Kits.

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Picus® Nxt Electronic Pipette

If you are isolating your clones through serial dilution techniques such that each culture well contains just one clone (monoclonality), you need to carry out a significant amount of liquid handling. Sartorius Picus® Nxt Electronic Pipette is the lightest electronic pipette on the market, with superior design, providing maximum pipetting convenience.

Picus Nxt user benefits:

  • Functions storage and easy activation of the dilution protocol
  • Multi-dispensing mode
  • Microplate tracker

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MYCAP® CCX Cell Expansion System

Reliable aseptic technique for cell culture expansion, MYCAP® CCX has a revolutionary closed design ensuring media feed, inoculation, sampling, and transfers are done aseptically—without the need for a biosafety cabinet.

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Centrisart Centrifuges

We have a centrifuge to accommodate any of your protocols, from microcentrifuge to 1,600 mL total capacity.

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Lab Weighing Solutions for your Physico-chemical Analytical Tests

HPLC Sample Preparation

Semi-automatic preparation and documentation of highly reproducible HPLC calibration standards with the Cubis® MSA dosing system.

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Cubis II — Your Balance, Your Way

For analytical test method development and physico-chemical characterization of lead candidates, researchers need reliable weighing solutions that provide reproducibility and connectivity with other lab systems

Seamless Connectivity — Easy integration with lab software (directly connected to PC) and LIMS avoids the need for separate software islands. USB-C and optional Bluetooth connectivity is also available.

Boundless Configurations — Vast selection of capacity and readability options, draft shield types, weighing pans and displays – 60,000 possible configurations.

Full End-to-End Data Integrity — User management and LIMS connectivity ensure that the data acquired is reliable and will not be manipulated.

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Resources

Application Note

From Mammalian Cell Cultures to Pure Proteins: Sartoclear Dynamics® Lab Significantly Reduces Cell Harvest Time

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Application Note

Rapid Mammalian Cell Harvest without Centrifugation for Antibody Purification Using the Sartoclear Dynamics Lab Filtration System

Read the Application Note

GEN Tutorial

Simplified Small-Scale Harvest of CHO Cells for mAb Analytics

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Application Note

The Mouse IgG Type and Titer Kit is a Single, Multiplexed Assay that Simultaneously Quantifies IgG isotype, IgG Quantity per isotype, Total IgG Secretion, Cell Count and Cell Health

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Webinar

Accelerating Nanobody Discovery Workflows with High-Throughput Flow Cytometry

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Product Sheet: Mycoplasma Assays for qPCR

PDF | 215.6 KB

Poster: Using the Intellicyt® Platform to Profile Antibody Dependent Cell Cytotoxicity

PDF | 1.2 MB

Brochure: Sartoclear Dynamics® Lab Convenient Mammalian Cell Culture Harvesting

PDF | 1.8 MB

Application Note: Minimizing Syringe Filter Usage in harvesting Monoclonal Antibodies from CHO Cell Culture Supernatants

PDF | 204.5 KB

Application Note: Vivaflow® 200: A Critical Sample Preparation Tool for Concentrating Hybridoma Supernatants

PDF | 680.9 KB

Application Note: Concentration of Mammalian Cell Culture Supernatants with Vivaspin® Turbo 15 and Amicon® Ultra-15 Devices

PDF | 138.5 KB

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