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mAbs Characterization & Quality Control

The key for ensuring drug safety and efficacy

HomeIntegrated OfferingsMonoclonal Antibodies (mAbs)Characterization and Quality ControlMicrobiological Testing

 

Characterization and quality control of monoclonal antibodies (mAbs) is essential to ensure their efficacy and safety. Analytical techniques, like HPLC and mass spectrometry, are vital to assess various properties, such as aggregation, charge variants, and post-translational modifications (PTMs). Our extensive selection of products supports the detailed analysis and evaluation of mAbs to maintain quality and effectiveness.

Characterization and Quality Control
Intact Mass Analysis
Peptide Mapping
Post-Translational Modification Analysis
Aggregate Analysis
Titer Determination
Microbiological Testing

Microbiological Testing

Monoclonal antibodies are particularly notable for their targeted therapeutic benefits and minimal off-target adverse effects, distinguishing them in the market. Microbiological testing ensures product safety and regulatory compliance in the monoclonal antibody production process through methods like environmental air monitoring, sterility testing, pyrogen testing, and the use of culture media. Invest in appropriate contamination prevention products to improve the reliability of your analytical results and ensure speed-to-market.

As the significance of pharmaceuticals continues to rise, so does the demand for precise analytical testing. This testing includes bioburden, mycoplasma, pathogen, and spoilage assessments, as well as pyrogen and sterility evaluations, all vital for upholding the stringent safety and efficacy standards expected of pharmaceutical products. We invite you to explore our extensive array of industrial microbiology solutions that help maintain quality and consistency throughout your monoclonal antibody (mAb) production workflow.

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Related Categories

Microbial Membrane Filtration Systems
Microbial Filtration

Simplify your microbial limit testing workflow, from filtration to culturing and detection.

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Sterility Testing Consumables, Media & Instruments

Tailor your Steritest® system to suit your sample, packaging, and controlled testing environment requirements.

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Viable Air Samplers

Easy-to-use air samplers for active air monitoring in critical areas.

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Pyrogen Testing

Pyrogen testing is vital to ensure the safety of pharmaceutical products and medical devices.

Large, brown solvent bottle with Supelco® branded label is opened by a lab worker wearing blue nitrile gloves. Only the hands and lower arms of the worker are shown. One small brown solvent bottle and two small white bottles can be seen in the background.
Microbial Culture Media

A wide range of dehydrated and ready-to-use culture media for your microbial testing needs.

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Microbial Culture Media Raw Materials

Explore our diverse range of granulated and powdered biological raw materials in many varieties.

Related Resources

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Related Webinars

The Route to Faster Microbial QC with Milliflex® Rapid System 2.0

Learn how proven ATP bioluminescence technology can reduce your time-to-result in microbial QC.

Bioburden and the new EU GMP Annex 1

The long-awaited revised Annex 1 on the Manufacture of Sterile Medicinal Products was published by the European Commission on August 25th, 2022.

Microbial Sampling of Compressed Gases Has Never Been So Simple and Safe

Compressed air and gases are used at different stages of many industrial manufacturing processes, so microbial compressed gas testing is an important part of contamination control programs.

Risk Considerations for the Presence of Pyrogens and the Need for the MAT Test

In this lecture, you will learn how to test for pyrogen (including non-endotoxin pyrogens) in your pharmaceutical samples, what are the existing methods in order to have a controlled process.

Get your Aseptic Facility Ready for EU GMP Annex 1

The upcoming Annex 1 revision will include guidance specifically on designing a risk-based and effective contamination control strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.

Environmental Monitoring Tools to Measure Microbiology Control

Environmental monitoring in a food manufacturing environment includes viable air sampling as well as surface sampling.

Related Services
M-Trace® Electronic Test Record Software
M-Trace® electronic test record software ensures full traceability for your sterility testing data and elevates your Steritest® Symbio pump to a whole new level. M-Trace® software reduces handling errors, ensures compliance, and boosts productivity.
Calibration for Microbiology Testing Systems
Calibration and verification services ensure microbiological test equipment reliability and performance.
Maintenance and Service Plans for Microbiology Testing Systems
Conformity of systems used to perform QC tests and sampling is critical to ensure reliability of test results. Discover our maintenance testing services plan offering portfolio to assure your equipment is with compliance and reliability.
System and Equipment Installation for Microbiology Testing Systems
Installation of your lab system is an important step before commissioning your equipment or prior to any qualification and it could be critical for system integrated in isolator.
Pharma QC Systems Qualification
Validation protocols ensure microbiology method quality, compliance, and documentation.
Pharma Microbiology Method Development & Validation
When a microbial test method (S.O.P.) needs to be set up for a new product or improved for a product that demonstrates antimicrobial effects and/or filtration issues, our applications laboratory can develop a method that is compliant with applicable regulations (Pharmacopoeias). As a company, we are known for the quality of our products. We apply these same high standards to our methods development assignments and keep the same strict attention to regulatory compliance.
Val@M™Application for Validation Activities
This Val@M™ application provides technology to help fulfill the requirement to keep electronic records of your validation activities around our QC platforms for microbial contamination testing.

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Immunoglobulin G antibody in blue and yellow
Antibody Drug Discovery
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Characterization & Quality Control
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