Tools to Advance Biosimilar Development
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.
View Infographic Request Information
Sartorius addresses your needs at every stage of the journey to commercialization, whether you need a fully outsourced solution or select products and services to complement your in-house cell line development (CLD) capabilities.
Explore More
Comparability studies are carried out throughout PD, and if there are any changes in the process, instrumentation or raw materials in future. CQAs are generated against several lots of the reference products and monitored throughout the lifecycle of the molecule even after commercialization of the drug
Explore Cell Analysis Explore Label-Free Detection
Octet® Bio-Layer Interferometry (BLI) platforms are commonly used for ligand binding assays, concentration measurements and glycan profiling. BLI is a label-free technology that allows users to determine association and dissociation rate constants in kinetic characterization experiments - key determinants in affinity constant derivation and information not available with end-point analysis techniques such as ELISA.
For comprehensive physicochemical and biological characterization, scientists often need multiple orthogonal technologies using in vitro cell-based and protein assays. Octet® BLI protein analysis, Incucyte® Live-Cell Analysis as well as iQue® 3 High-Throughput Cytometry platforms are widely used for demonstrating similarity of antibody binding to target antigens and Fc gamma receptors and for evaluating functional activity and mechanism of action.
Clarifying high cell density mammalian cell cultures with one-step clarification and sterile filtration method. Simplify sample preparation with a one-step procedure with the Vivaspin® and Vivaflow® Ultrafiltration Devices.Maximize recoveries of any target molecule. Concentrate any sample in the 0.1 mL to 5 L range.
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
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®.
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.
A high-throughput screening cytometry platform with a focus on speed to get you from samples to actionable results in record time.
Gain unprecedented time and cost savings for kinetics, affinity and concentration assays.
Allows visualizations and direct quantitation of the full timecourse of biology like cell activation, proliferation and vitality.
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.
Semi-automatic preparation and documentation of highly reproducible HPLC calibration standards with the Cubis® MSA dosing system.
With completely configurable hardware, software and connectivity, Cubis® II offers a high-performance balance that will align with your unique demands and compliance requirements.
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.
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.
Read Application Note
Orthogonal Analysis Using Ligand Binding Kinetics and Live Cell Binding
Many challenges can arise when developing a biosimilar. View this infographic to understand those challenges and how to overcome them.
Application Note describing how the iQue® Human Antibody Dependent Cellular Phagocytosis Kit has been used to measure Antibody-Dependent Cellular Phag...
The Octet® Bio-Layer Interferometry instrument was used for invitro binding studies of pembrolizumab, as supporting data in the binding characterizati...
Our experimental findings demonstrate antibody-mediated cellular phagocytosis, substantiate the recognized pro-phagocytic effects of anti-CD47 and ant...
Learn about the relationship between therapeutic antibodies and analytical balances – and how Cubis® II can streamline the testing process.
Globally, hundreds of biosimilars are going through the drug development pipeline. Our assay development expert explains the latest trends and the nee...
A Perfect Fit, From Start to Finish: Cell line development with intelligent tools, services, and solutions for your unique needs.
Please select your country so we can show you products that are available for you.
The content of our website is always available in English and partly in other languages. Choose your preferred language and we will show you the content in that language, if available.