mAbs Characterization & Quality Control
The key for ensuring drug safety and efficacy
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.
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.
Related Categories
Simplify your microbial limit testing workflow, from filtration to culturing and detection.
Tailor your Steritest® system to suit your sample, packaging, and controlled testing environment requirements.
Easy-to-use air samplers for active air monitoring in critical areas.
Pyrogen testing is vital to ensure the safety of pharmaceutical products and medical devices.
A wide range of dehydrated and ready-to-use culture media for your microbial testing needs.
Explore our diverse range of granulated and powdered biological raw materials in many varieties.
Related Resources
- Milliflex Oasis® Filtration System for Bioburden and Pharmaceutical Water Testing
The Milliflex Oasis® filtration system is a complete solution for monitoring in-process samples, water, filtrable raw materials, and finished products for bioburden and microbial limits testing. The system increases QC lab productivity while reducing the risk of false results.
- Steritest® Symbio Sterility Testing Pump & Accessories
The user-friendly Steritest® Symbio pumps and accessories are designed for easy and reliable sterility testing. The system improves your workflow and maximizes safety, confidence, and convenience.
- Steritest® NEO Membrane Filtration Sterility Test
Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products.
- Early Microbial Detection and Enumeration with Milliflex® Rapid System 2.0
Milliflex® Rapid System 2.0, an automated solution for rapid microbial detection supports QC labs to substantially reduce the time-to-result of sterility, bioburden, in-process, and product release testing. Thanks to the ATP bioluminescence technology, the system delivers 4 times faster results than traditional methods.
- Portable Microbial Air Samplers
Our active microbial air samplers generate accurate and reproducible results for effective use in pharmaceutical, medical device, food and beverage industries where regulations are on the rise, and standards become increasingly stringent.
- Environmental Monitoring in Isolators
IsoBag™ ease the environmental monitoring workflow in aseptic production isolator
- Environmental Sample Pre Storage on Counting Results
Microbial monitoring; environmental monitoring; interim storage; ICR contact plates; contact plates; TSA w. LTHThio Contact ICR+
- Application: Mycoplasma Testing in the Pharmaceutical Industry
Mycoplasmas can grow to high titers in culture cultures, adversely impacting these. In the pharmaceutical industry Mycoplasma testing is key to detect contamination early and avoid loss of time and production batches.
Related Webinars
Learn how proven ATP bioluminescence technology can reduce your time-to-result in microbial QC.
The long-awaited revised Annex 1 on the Manufacture of Sterile Medicinal Products was published by the European Commission on August 25th, 2022.
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.
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.
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 in a food manufacturing environment includes viable air sampling as well as surface sampling.
Explore our Products & Services
To continue reading please sign in or create an account.
Don't Have An Account?