Tools to Advance Biosimilar Development

Simplifying the Complexity of Proving Biosimilarity

Biosimilars are biological medicines that are extremely similar to already-approved biopharmaceutical drugs (originator or reference medicinal product (RMP)). Biosimilars can be manufactured when the original product’s patent expires. 

A comprehensive analytical data package is the foundation of bringing a biosimilar to market. It is critical that drug developers prove there are no clinically meaningful differences between the biosimilar and its RMP in terms of the safety, purity and potency of the product. 

Discover how Sartorius solutions can simplify this complex process and help bring your biosimilar to market faster.

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                       Biosimilars Development Workflow

Sartorius Biosimilar Development Solutions Offer:

Multifactorial Analysis
Plate Filling
Diagram Monitor
Actionable results for more insight

Analyze multiple parameters with the same assay:

  • High throughput, multiplex assay that measures ADCP via co-localization of encoding dye-labeled target cells with CD14 positive effector cells using a simplified, streamlined workflow with iQue® 3 High-Throughput Cytometry Platform

  • Glycan screening combined with titer measurement with Octet® BLI

  • Visualization and direct quantification changes in morphology, movement and spatial orientation of cancer and immune cells over days and weeks

Sample Conservation

Conserve precious sample through multiplexing – analyze multiple parameters from the same well from low sample volume (as little as 1uL minimum sample volume requirement) with iQue® 3 High-Throughput Cytometry Platform.

Lower hands-on manipulation and sample consumptions; more in-depth analysis method compared to ELISA using Octet®.

Automated Analysis

iQue® 3 High-Throughput Cytometry Platform enables rapid, high-throughput walkaway plate sampling and automated analysis and reporting.

Incucyte® Live-Cell Analysis System automatically acquires and analyzes phase and fluorescent images of cells around the clock.

Product Highlights for Biosimilar Development 

iQue® 3 High-Throughput Cytometry Platform

A high-throughput screening cytometry platform with a focus on speed to get you from samples to actionable results in record time.

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Octet® BLI Label-Free Detection for Biomolecular Interactions Analysis

Gain unprecedented time and cost savings for kinetics, affinity and concentration assays.

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Incucyte® Live Cell Analysis uses whole-well, label-free imaging to scan clones and verify monoclonality.

Incucyte ® Live-Cell Analysis System

Allows visualizations and direct quantitation of the full timecourse of biology like cell activation, proliferation and vitality.

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Vivaspin® and Vivaflow® Ultrafiltration Devices

With a wide range of process volumes and a broad choice of membrane materials and molecular weight cut-offs, Vivaspin® and Vivaflow® serve as the perfect tools for every lab scale protein, nucleic acid, nanoparticle or virus concentration step.

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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: 100% Configurable Laboratory Balance

With completely configurable hardware, software and connectivity, Cubis® II offers a high-performance balance that will align with your unique demands and compliance requirements.

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Biosimilar Testing Services

As the leading experts in biosimilars, we understand demonstrating your biosimilar has fingerprint-like similarity to the reference product is a complex process. With our complete range of testing and development services from biosimilar cell line development, off-the-shelf and custom assays, to biosafety testing and cell bank manufacturing - and our unrivalled expertise in the field - we are your complete solution provider.

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Frequently Asked Questions

It does not require cells be removed from the incubator and lifting, washing or labeling with perturbing (and expensive) antibodies is not necessary. This eliminates a wide range of potential assay artifacts and affords significant additional biological insight. 

To compare the antibody-dependent (tumor) cell killing (ADCC) of trastuzumab and potential biosimilar mAbs, Incucyte® CLCA assays were assembled with co-cultures of HER2-positive SKOV-3 ovarian cancer cells and peripheral blood mononuclear cells.

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Challenges and Solutions in Developing Biosimilars

Many challenges can arise when developing a biosimilar. View this infographic to understand those challenges and how to overcome them.

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Streamlined Workflow for Antibody-Dependent Cellular Phagocytosis

Application Note describing how the iQue® Human Antibody Dependent Cellular Phagocytosis Kit has been used to measure Antibody-Dependent Cellular Phag...

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Octet Instrument Comparability Kinetics Precision Assessment

Instrument Comparability Assessment: Kinetics Precision Assessmen...

The Octet® Bio-Layer Interferometry instrument was used for invitro binding studies of pembrolizumab, as supporting data in the binding characterizati...

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Applications of Live-Cell Analysis for Phagocytosis in Real-Time

Applications of Live-Cell Analysis for Phagocytosis in Real-Time

Our experimental findings demonstrate antibody-mediated cellular phagocytosis, substantiate the recognized pro-phagocytic effects of anti-CD47 and ant...

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Reliable, Consistent Prep of Buffers & Solutions

Learn about the relationship between therapeutic antibodies and analytical balances – and how Cubis® II can streamline the testing process.

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Ben Tyrrell blog post image

From Whole Well to Single Cell: Enhancing Biosimilar Development 

Globally, hundreds of biosimilars are going through the drug development pipeline. Our assay development expert explains the latest trends and the nee...

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Additional Solutions

Cell Line Development

A Perfect Fit, From Start to Finish: Cell line development with intelligent tools, services, and solutions for your unique needs.

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