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Insightful Solutions for Biologics Drug Discovery with a Focus on Monoclonal Antibodies (mAbs)

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Insightful Solutions for Biologics Drug Discovery with a Focus on Monoclonal Antibodies (mAbs)

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Sartorius Solutions for Monoclonal Antibodies (mAbs) Discovery and Development

Biomolecular Interaction Analysis Platforms for Antibody Discovery and Cell Line Development

Gain More Insights, Make Better Decisions

Therapeutic antibodies have recently emerged as one of the most successful strategies for the treatment of both hematologic cancers and solid tumors. Because they offer the promise of better specificity and safety than many other cancer treatments, this class of biologics is projected to continue increasing in importance.

Octet® BLI systems are used for affinity characterization, off-rate ranking, epitope binning of small to large antibody matrices, Fc-receptor binding, cross-reactivity testing of other species, glycosylation screening, characterization of

antibody-antigen binding kinetics and affinity, bispecific testing, and titer analysis for protein expression, all in one high-throughput, easy-to-use system.

Accelerate Your Antibody Development and Still Have Peace of Mind

For development of breakthrough therapeutics you need revolutionary technologies providing rapid, multifactorial results to enable deeper insights and ensure the choice, quality, and integrity of your biopharmaceutical product.

We do this by enabling - Process streamlining- Multiplexing- Acquisition of information-rich data - More meaningful and biologically relevant insights

See how our unique and innovative technologies and solutions ensure your confidence in the results of your research and the quality of your product at every stage of the biologics discovery and development workflow.

Crude or �purified��protein

Octet® GlyS / GlyM Kit

Octet® Analysis Studio

Titer/ Quantitation

Mannose Content vs. Titer

Sialic Acid Content vs. Titer

Man

nose

Con

tent

Sial

ic A

cid

Con

tent

Protein titer

Protein titer

Relative glycan screening

Titer Analysis

Time (seconds)

Bind

ing

Glycan Screening

Time (seconds)

Bind

ing

Quantitation biosensor*

Features Value

Antibody titer and glycosylation profiling using crude samples

- Significantly reduce time to develop antibodies by combining titer and glycan screening- Save FTE costs and perform more projects using a high-throughput Octet® BLI system

Affinity determination and kinetic characterization

- Assess the binding characteristics of your biologics molecules in real-time - Accurately determine rate constants of association and dissociation for biomolecular interactions studies

Epitope binning and cross reactivity testing using crude samples

- New BinChart for convenient binning of antibodies- Advanced settings for fitting quantitation datasets- Optimal visualization via overlaid fitted traces on top of raw quantitation binding traces- New capability for reference subtraction within and across plates- Optimized Report Tab for direct creation of PowerPoint/PDF reports

Off-rate screening using crude samples - Rapid antibody of rates screening using crude samples

Complete with comprehensive analysis and visualization capabilities, our platforms will empower you with actionable results, faster!

Antibody Library ScreeningIncrease data throughput and quality by multiplexing antibody binding, specificity, and species cross reactivity.

ProliferationMeasure cell proliferation in mono- or co-cultures, with or without labels.

3D Tumor Spheroid AssaysTrack and quantify tumor spheroid formation, growth, and death in real time.

Functional ProfilingEasily go from high-content functional assays to actionable information that helps you select candidates with desirable biological activity.

ApoptosisInvestigate aberrations in apoptotic pathways in intact, living cells.

Cell Migration and InvasionMonitor and analyze migration and invasion with or without a chemotactic gradient.

Cell Line DevelopmentSelect antibody producing clones upstream of cell line development by simultaneously detecting IgG titer, cell health, and viability.

CytotoxicityDetect real-time measurements of cell death based on cell membrane integrity.

Antibody InternalizationQuantify antibody internalization in 96- or 384-well formats.

The Incucyte® Live-Cell Analysis, iQue® Advanced Flow Cytometry, and Octet® Label-Free Analysis systems offer unique, high-capacity cell and protein analysis solutions for characterizing cell phenotype and function and tracking complex biological processes.

Legend:

Cell and Protein Analysis Platforms for Tracking Complex Biological Processes

iQue® Incucyte® Octet®

Find out more For more information, please visit www.sartorius.com/mAb-oncology

Vivaspin® Ultrafiltration Devices and Vivapure® Virus Purification Kits

Picus® Nxt Electronic Pipette

Midi Plus Pipette Controller

Sample Prep and Supporting Tools Fill-it Automated Cell Banking System

Expand your capabilities with our cell line development servicesThe Sartorius CHO Platform bundles the industry-leading Cellca Cell Line Development service with a fully optimized cell culture media system, cGMP cell banking, protein characterization services and biosafety testing to create an integrated solution for protein-based therapeutics.

� From DNA to a fully characterized Master Cell Bank in less than 5 months � The platform offers reduced costs and development risks, proven results,

and exceptional flexibility

Produce large, homogenous banks of cells under cGMP conditionsFill-it Automated Cell Banking System offers improved consistency and shortens process times compared to manual processing, giving the potential to increase batch sizes for cell banking and dramatically reduce QC costs.

� Fits in a standard biosafety cabinet � Facilitates easy loading and operation � De-caps racks of cryovials held in either 96-, 48- or 24-vial racks � Provides automated cell banking compatible with wide microtube range

Cell Line Development Services

Incucyte® Live-Cell Analysis System

Ambr® 15 Cell Culture Bioreactor System

iQue® Advanced Flow Cytometry Platform

Molecule Development Workflow

Target IdentificationMultiparametric and actionable results for more insight and better decisions

Gene Cloning and Initial Clone SelectionRapid screening of minipools for product titer, cell health and growth

Library ScreeningScreen whole-cell binding hybridoma or phage library to identify positive hits

Clone Selection and Confirmatory AnalysisEarly identification of high productivity clones with opti-mal critical quality attributes

Lead OptimizationAssess and optimize the properties of lead antibodies

Cultivation and Media OptimizationScreen culture conditions and media formulations for optimal growth and protein production

Candidate CharacterizationAnalyze the structural properties of the lead antibodies as well as binding and functional properties

Cell Line Evaluation and CharacterizationCharacterize top clone for stability, productivity, and quality attributes of the protein

Cell Line Development Workflow

Octet® Bio-Layer Interferometry (BLI) Detection Systems for Label-Free Detection

Multiparametric and actionable results for more insightA high-throughput, suspension cell and bead-based analysis platform for antibody screening and functional profiling. The fastest way to generate high content data from small sample volumes.

� Screen your libraries in days, not months � Sample volumes as low as 1 µL, reduce reagent costs � Screen cells in suspension and targets in their natural conformation

See specific applications in “Cell Analysis Platforms”

Hit ConfirmationConfirm hits in kinetic binding assays

Cell BankingResearch Cell Bank (RCB), Master Cell Bank (MCB), and Working Cell Bank (WCB) preparation

Sartoclear Dynamics® Lab

Rapid Contamination control – Microsart® Mycoplasma & Sterility Testing

See what your cells are doing and whenEnable real-time, live-cell imaging and analysis directly inside your incubator.

� Use with non-perturbing Incucyte® reagents to detect dynamic biological changes

� Measure kinetic effects of your antibody treatment on target cells � Accommodates multiple users and applications in parallel

See specific applications in “Cell Analysis Platforms“

Perform protein quantitation and kinetics characterization assays Measure molecular interactions in real-time without the need for detection reagents and enable advanced, fast, and fluidics-free direct detection of specific biomolecules.

Rapidly determine product titer, screen for specific glycosylation content and perform off-rate analysis to select optimal clones using both purified and unpurified samples

Cell Line, Media & Testing Service Benefit from our experience in custom cell line developmentThe Sartorius CHO Platform bundles the industry-leading Cellca Cell Line Development service with a fully optimized cell culture media system, cGMP cell banking, protein characterization services and biosafety testing to create an integrated solution for protein-based therapeutics.

� From DNA to a fully characterized Master Cell Bank in less than 5 months

Octet® Bio-Layer Interferometry (BLI) Detection Systems for Label-Free Detection

iQue® Advanced Flow Cytometry Platform

Microsart® Rapid Mycoplasma & Sterility Testing qPCR kits offer a rapid, reliable, and easy-to-use solution for microbial quality control in compliance with international guidelines.

� Don’t worry about false positives due to TaqMan® probes � Let the Master Mix do the internal control and reduce tedious

pipetting steps � Eliminate contamination risks by using only non-infectious CFU

standardsVivaspin® Centrifugal Concentrators providenear total mAb, protein, virus, and other nanoparticle concentrations in maximum speeds. Now with the unique offering of both PES and RC membranes to optimize molecule to membrane compatibility.

� Unique PES and RC membrane range � Fastest concentration times � Angular dead stop for complete sample

retrieval � Market leading technical and application

support

Sartoclear Dynamics® Lab is a new method for harvesting mammalian cell cultures in one-step filtration without any centrifugation for clarification.

� Time saving because of singlestep filtration, no setup required, and high flow rates

� No lengthy centrifugation step needed � Efficient, as only one filter needed � Convenient, as hand-free filtration

of up to 6 samples in parallel

Picus® Nxt is the lightest and smallest electronic pipette on the market. Its ergonomic design allows comfortable handling to ease the work-load of laboratory professionals in long pipetting series.

� Fully electronic operation for consistent, user independent results

� The extensive range of pipetting modes makes pipetting tasks quick and easy

� Features like programmable protocols and plate tracker reduce the risk of user errors

Solutions & Services for Molecule Development Solutions & Services for Cell Line DevelopmentPerform protein quantitation and kinetics characterization assays Measure molecular interactions in real-time without the need for detection reagents and enable advanced, fast, and fluidics-free direct detection of specific biomolecules.

Rapidly determine product titer, screen for specific glycosylation content, and perform off-rate analysis to select optimal clones using both purified and unpurified samples.

Multiparametric and actionable results for more insightA high-throughput, suspension cell and bead-based analysis platform for antibody screening and functional profiling. The fastest way to generate high content data from small sample volumes.

� Screen your libraries in days, not months � Sample volumes as low as 1 µL, reduce reagent costs

� Screen cells in suspension and targets in their natural conformation

See specific applications in “Cell Analysis Platforms”

Improve the overall efficiency and speed of your cell line and mediasAmbr® 15 Cell Culture is a high-throughput automated micro bioreactor for predictive cell line and media screening. Rapidly evaluate multiple bio reactor cultures at microscale, thus increasing your productivity in cell line development and saving on materials and labor.

� Rapid screening of clones and media optimization � Data-rich culture profiles with automated sampling � Large multifactorial experimental designs (DoE) in real-time

Midi Plus is a lightweight and easy-to-use pipette controller for large volumes.

With Midi Plus you are in control. Aspiration and dispensing speed can easily be controlled by using the adjustment wheel and fine-tuned by adjusting finger pressure on the operating buttons.

Find out more For more information, please visit www.sartorius.com/cld

Specifications subject to change without notice. Copyright Sartorius Lab Instruments GmbH & Co. KG. Version 12 | 2021

Germany Sartorius Lab Instruments GmbH & Co. KG Otto-Brenner-Strasse 20 37079 Goettingen Phone +49 551 308 0

USASartorius Corporation North America Inc. 565 Johnson Avenue Bohemia, NY 11716Toll-Free +1 800 368 7178