Simplify your seed train intensification with high cell density cryopreservation (HCDC). Eliminate the need for time-consuming manual scale-up steps and enable risk reduction through closed banking and inoculation processes.

Explore a complete workflow of a middle-up mass analysis of protease digested Cetuximab mAb, starting with the antibody purification, proteolysis, and reduction to its reversed phase UHPLC-MS analysis.

Explore the results of using a carbon LC column to separate vitamin D2 and D3 and their metabolites and epimers.

We review a protocol for heat stressing and SEC-UV analysis of monoclonal antibody aggregates and fragments.

This application note reviews a technique that has been demonstrated to provide significant timesaving for protein binding determination when compared with the rapid equilibrium dialysis method.

Learn about a LC-MS/MS method for analyzing all 20 amino acids, without derivatization, utilizing a carbon LC column.

Learn how rapid detection methods allow you to address contamination events sooner, avoid line shutdowns, release product to the market faster, and reduce warehousing costs.

Ethanol and gel-based disinfectants must undergo QC controls to ensure that the bioburden is below an acceptable level. We demonstrate a convenient and sensitive method for the quantitative rapid detection of contaminants in filterable samples.

Learn about a glycoprofiling workflow for the Rituximab monoclonal antibody: from its purification, reduction, and separation by size exclusion, to its measurement and analysis by mass spectrometry

Discover the risks and sunken costs of sticking with traditional inventory management practices. Additionally, learn how motion waste in the laboratory material lifecycle takes a toll on productivity.

In this eBook scientific experts discuss newer, faster, and more efficacious strategies for peptide mapping and analysis of biotherapeutic products.

This practical guide on all aspects of High-performance liquid chromatography (HPLC) method development will help you making it through the maze of HPLC options.

Bioburden control is an integral component of every biologics production process. Determining the appropriate bioburden control strategy can be challenging given the many different technologies available for today’s biologics manufacturers. In this eBook, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization. In addition, we focus on industry trends toward intensified processing and increased implementation of single-use systems, and how they are changing expectations for sterile filtration and bioburden control.

This interview gives insights into the issues and obstacles faced by pharmaceutical companies, the current regulatory framework.

Experts explain what pyrogen is and the difference between an endotoxin pyrogen and a non-endotoxin pyrogen. Learn why it so important to detect non-endotoxin pyrogens.

Tim Sandle, Head of Microbiology at BPL and visiting tutor of University of College London & University of Manchester, answers several questions raised by the community around pyrogen and endotoxin tests, regulations, how the Monocyte Activation Test (MAT) works in practice.

Find responses to the 20 most burning questions we received around microbial testing, analytical testing, biologics characterization, vaccines development, dissolution testing, method development, data traceability, regulations, and more.

As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.

Traditional bioburden testing (or microbial limit testing)  takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the systemwhen they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.

Bioburden testing and microbial limit testing, are a quality control test to determine the total number of viable microorganisms (of pharmaceutical and medical products. Thanks to its many cleverly designed features, the Milliflex Oasis® is a particularly productive and reliable membrane filtration method for performing bioburden testing in accordance with USP, EP and JP recommendations, ensuring that patients can call upon microbially safe products.

Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs testing in the course of pharmaceutical quality control. Test methods being used are the rabbit pyrogen test (RPT), the bacterial endotoxin test (or LAL test), and the monocyte activation test (MAT).

Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.