Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.

Drugs formulated with antibiotics, preservatives, or other chemicals may inhibit microbial viability and growth. Learn more about three golden rules to be effective against antimicrobial effects.

Discover one possible test set-up to dilute a product in isopropyl myristate, filter it, and rinse the membrane to eliminate residues that may inhibit microbial growth.

Discover a chito-oligosaccharide that significantly improves the solubility of antibody-drug conjugates (ADCs) when included in the linker-payload construct.

Accurate testing results are crucial for product safety. Explore the findings of a comparative study evaluating two different platforms for the membrane filtration of microorganisms in quality control.

In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex® Rapid System to establish a USP and EP compliant method for rapid sterility testing.

This study was designed to prove the suitability of ICR Swabs and lockable TSA w. LTHThio contact plates to detect low numbers of different bacterial test strains from Neoprene® gloves.

Contact plates and swabs are commonly used for surface monitoring in aseptic manufacturing. Here, we demonstrate the recovery rates of MilliporeSigma’s ICR Swabs and lockable TSA w. LTHThio contact plates.

Environmental monitoring plays an important role in pharmaceutical manufacturing contamination control. Learn how MilliporeSigma and the BioTrends EM® software system pair together for your data analytics.

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

Explore a complete reversed phase UHPLC-MS workflow, developed to simplify middle-up mass analysis of an immunoglobulin G antibody, from the antibody purification, proteolysis, and reduction to its UHPLC-MS analysis.

Here, we demonstrate the use of the Supel™ Carbon LC UHPLC column to baseline separate the vitamin D2 and D3 forms from the D2 and D3 epimers.

Characterizing mAb aggregate and fragment formation during drug formulation and establishing a suitable quality control process is essential. Learn about a complete workflow for antibody aggregate and fragment quantification.

Here, we review a technology that has been demonstrated to significantly reduce the time required for protein binding determination when compared with the rapid equilibrium dialysis method.

The wide-ranging polarities spanning across all 20 amino acids can make analysis challenging. Learn about an LC-MS/MS method that achieves this, without derivatization, utilizing a carbon LC column.

Various water samples were tested to assess the ability of the Milliflex® Quantum System to detect microbial contaminants quicker and to evaluate the reduction of time-to-final result compared to the compendial method.

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

Proper characterization of therapeutic mAbs is essential for ensuring drug safety and efficacy. Discover a complete SEC-MS workflow, developed to enable rapid glycoprofiling of mAbs in cell culture supernatants.

The modern microbiology laboratory is starting to look very different from the laboratory of even 10 years ago. The work will be similar, yet technology will have advanced. Automation, in particular, is taking center stage.

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.

Explore expert insights into newer, faster, and more efficacious strategies for peptide mapping, the analysis of novel biotherapeutic products, and more.

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

Determining the appropriate bioburden control strategy can be challenging. This eBook covers differing objectives for bioburden control, parameters to guide filter selection and optimization, industry trends, and evolving expectations.

Gain insight into the issues and obstacles faced by pharmaceutical companies, the current regulatory framework surrounding viral vaccines, and how one company is preparing for the next outbreak.

Experts explain what a pyrogen is as well as the differences between an endotoxin pyrogen and a non-endotoxin pyrogen. Learn why it is immensely important to detect non-endotoxin pyrogens.

Tim Sandle, Head of Microbiology at BPL and visiting tutor of the University of College London & University of Manchester, answers questions about pyrogen and endotoxin tests, regulations, and more.

Find responses to the 20 most burning questions surrounding microbial testing, analytical testing,  vaccine development, dissolution testing, method development, data traceability, regulations, and more.

SMALL MOLECULE SYNTHESIS, FROM PRECLINICAL TO COMMERCIAL QUANTITIES

With Millipore^® CTDMO Services we support small molecule API synthesis projects from milligram to commercial quantities. We are the partner to address the most difficult challenges, whether the target is difficult to handle, synthesize, or source. With a true consultative and partnered approach, our services reduce complexity and minimize program risk in a cost-effective manner.

Immerse yourself in a self-guided, virtual tour of an M Lab™ Collaboration Center!

The Milliflex® Rapid System 2.0 brings together membrane filtration and ATP bioluminescence to detect, image and quantify microcolonies of bacteria, molds and yeasts up to 4 times faster than compendial bioburden or sterility testing methods.

Pour them with confidence!

Processing large batch sizes in one run using single-use equipment is a challenge. The Mobius® TFF 80 system has been designed for large-scale tangential flow filtration, with flow rate capabilities up to 80 L/min and up to 20 m² of membrane area installed.

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 system when 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 quality control tests for determining 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.

Quality control is a critical component for ensuring safety, efficacy, and consistency in the development and production of biologics. This comprehensive list of strategies, techniques, workflows, and best-in-class products for developing biopharmaceuticals can help you navigate the complexities of biologics and simplify the manufacturing process. Improve your quality control procedures and optimize your biologics production process with tools and expertise relied upon by researchers worldwide.

Regulatory compliance and traceability are essential for biopharmaceutical companies to ensure the safety and quality of their products. The pharmaceutical industry is heavily regulated, and companies must adhere to a wide range of laws and regulations in order to remain compliant. Traceability is a crucial component of regulatory compliance, as it allows companies to track the history and movement of their products throughout the supply chain. Having a strong focus on traceability and compliance is key to operating a safe and efficient quality control (QC) lab. This comprehensive list of expert insights, strategies, tools, and techniques for achieving complete traceability and regulatory compliance can help you transform your QC lab.

Culture media selection is of utmost importance, as it directly impacts key elements of your quality control strategy, especially for environmental monitoring in cleanrooms and isolators in aseptic manufacturing. Explore a collection of expert guidance on environmental monitoring and culture media selection, study findings, and innovative solutions that can help you optimize your contamination control strategy. Further, gain insight into the impact of manufacturing guidelines and media features and specifications on environmental monitoring testing.

Filtration is a critical aspect of pharmaceutical manufacturing, as it helps to ensure the quality, safety, and purity of the final product. This comprehensive list of strategies to reduce bioburden, guidance on filtration selection, and expert insights on regulation, filtration, sampling, and quality control can help you optimize your contamination control strategy and ensure effective filtration in your production process. Explore high-performance specialty membranes and filtration devices relied upon by laboratories worldwide and across the academic, pharmaceutical, biotechnology, and industrial sectors.

To effectively monitor product quality, it is critical to test for microbial contamination throughout the pharmaceutical manufacturing process. Sterility testing is a vital step to ensure products purporting to be sterile do not contain viable microorganisms prior to their distribution and administration to patients. Consequently, it is of utmost importance that the testing method employed for products, formulations, tissue materials, and medical devices is both accurate and reliable. Explore a collection of streamlined sterility testing solutions and expert guidance on sterility testing, quality control (QC), and data integrity. Optimize your sterility testing and QC procedures with world-leading tools and technologies that can help you ensure full traceability and regulatory compliance.