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mAb Cell Line Development - Cell Line Characterization

Cell Line Characterization 

Before market release, cell lines and cell banks must be fully characterized. Precisely assess all properties of your cell lines with Sartorius’s combined solutions of advanced analytical and biosafety testing with the highest resolution and sensitivity.

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Challenges and Solutions for Developing New Monoclonal Antibodies

Unprecedented advances in medicine are delivering remarkable results for some patients. Recent approvals of CAR T therapies and new approaches in regenerative medicine, for example, exemplify Monoclonal antibodies (mAbs) used for immunotherapy stimulate the immune system to mount a response to target antigens. These powerful therapeutics are being used to...

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Intellicyt® iQue Screener PLUS

Multiple rounds of monitoring are required when screening for the desired antibody characteristics operating on immune cell function.

Easily identify and rank your mAb for desired functional criteria with large multi-plate screening campaigns using the Panorama feature of ForeCyt® software, part of the iQue Screener PLUS platform.

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Sartoclear® Dynamics Lab P15 and Lab V

Rapid and convenient clarification of high-density mammalian cell cultures is often challenging. Sartoclear® Dynamics Lab provides a single-step clarification and sterile filtration protocol 70% faster than traditional centrifugation--without clogging.  Quickly and easily harvest your target molecule from clarified supernatant with our simplified, small-scale mammalian cell harvest tools for antibody preparation before 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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Sartorius Stedim BioOutsource Testing Services

The foundation for approval of novel biological entities and biosimilar drugs is built on a robust analytical data package that proves the safety, purity, and potency of your product. Our BioOutsource analytical testing package combines physiochemical and biological analysis for in-depth characterization and comparability studies from a single contract partner. Our service uses platform methods, off-the-shelf assays, and custom developed bioassays to enable rapid data-driven decisions during drug development and is available for pre-clinical through clinical phases and lot release. 

BioOutsource Testing Services provides a unique range of integrated testing services to support biopharmaceutical drug development with physicochemical and biological characterization services for biologics.

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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

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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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White Paper:

Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

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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

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Poster: Using the Intellicyt® iQue Screener PLUS to Profile Antibody Dependent Cell Cytotoxicity

PDF | 1.2 MB

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Brochure: Sartoclear Dynamics® Lab Convenient Mammalian Cell Culture Harvesting

PDF | 1.8 MB

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

PDF | 204.5 KB

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

PDF | 680.9 KB

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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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