
MILLIPORESIGMA
The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 19,000 employees and 72 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery, improving quality of life for patients, fostering the success of customers and helping to meet global challenges. With a mission to streamline and improve the efficiency of analytical processes and methods, the organization has extensive expertise in developing advanced laboratory water solutions, sample filtration, smart chemicals, consumables, instrumentation, microbial testing and overarching digital connectivity for research, industrial, pharmaceutical, and medical applications.
For your pharmaceutical analysis and QC, whether you are working on small or large molecules, you can trust our portfolio and expertise to ensure quality and reliability throughout the entire product characterization, method development, manufacturing and quality control process.
ARTICLES AND WHITE PAPERS
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In the pharmaceutical industry, innovation and administration are in a constant tug of war. How can you better manage routine administration tasks that steal 40% of your team's valuable time?
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Explore an overview of the main inventory management challenges faced by fast-paced biotech and pharmaceutical laboratories that highlights how this directly impacts research outcomes, costs, and regulatory compliance.
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Get updated on recent and current advances in metabolome analysis by mass spectrometry with this introduction to the different approaches and technologies.
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This study investigates the efficiency of disinfectant-neutralizing agents added to the culture media of contact plates and swabs for surface monitoring.
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Recent technological advances in mass spectrometry based methods have made it easier to overcome the challenges of glycoprotein analysis.
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We review a combined procedure in which compendial testing is complemented by a simultaneous rapid test that uses the identical sample to generate much earlier results while allowing the compendial test to continue.
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Filter validation is a critical part of various pharmaceutical QC tests and require accurate analyte quantitation, therefore analyte binding is an important factor.
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In this article, we will explore tips to improve the method of size-exclusion chromatography (SEC), which is often used to measure monomer/aggregate and fragment content of mAbs and ADCs.
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We look into how the pharma analysis & QC community envisions future trends and explore if the challenges faced by your peers are the same as yours.
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In QC, there is still huge potential to accelerate the release of safe products. Here we review ways to boost the reliability, data integrity and productivity of microbiological testing.
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Pyrogen detection is one of the mandatory release tests for sterile parenteral drugs. Another test method that has increasingly been used the past few years doesn't require animals for pyrogen detection.
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The measurement of pyrogens is an important safety measure for parenterally applied drugs. We explore the several advantages the Monocyte Activation Test (MAT) provides over the rabbit pyrogen test.
WEBINARS AND PODCASTS
BROCHURES AND GUIDES
- M-Trace™ Software For Trusted And Efficient Data Recording
- Software To Automate And Digitalize Data Recording Steps In QC Workflows
- Solution For Rapid Sterility And Bioburden Testing
- Ergonomic HDPE Bottles For Acids, Bases, And Solvents
- Inventory Manager
- Unlock Your QC Lab's Full Potential With A Digital Key
- Supel™ BioSPME 96-Pin Devices
- Lab Efficiency Calculator
- Chiral HPLC Columns For Chiral HPLC And LC-MS Separations
- Monkeypox Oligos - Primers & Probes For Research & Commercial Use
- Optimize Your Contamination Control Strategy
- Resins Selection Guide
- Millipore® Filtration Selection Guide
- The Full Range Of Mycoplasma Culture Media
- Supel™ BioSPME 96-Pin Devices For Fast And Simple Plasma Protein Binding Studies
- Separate Proteins, Peptides & Glycans Faster With BIOshell™ U/HPLC Columns
- RP-HPLC Columns For Proteins And Peptides
- Milliflex® Quantum Rapid Microbial Detection System
- Microbial Culture Media For Quality Control Of Non-Sterile Products
- Detection Of Endotoxin And Non-Endotoxin Pyrogens By Monocyte Activation Test (MAT)
- Secure Your Pharma Analysis & QC
- A Quick Guide To Dissolution Testing
- Complete Sterility Testing Solutions For Complete Confidence
- Milliflex Oasis® system - A Complete Solution For Bioburden And Pharmaceutical Water Testing
VIDEOS
CONTACT INFORMATION
MilliporeSigma
400 Summit Drive
Burlington, MA 01803
UNITED STATES
Phone: 1-800-645-5476
APPLICATION NOTES
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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.
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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.
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Explore the results of using a carbon LC column to separate vitamin D2 and D3 and their metabolites and epimers.
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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.
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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.
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The wide-ranging polarities spanning across all 20 amino acids makes analysis challenging. Learn about a LC-MS/MS method for analyzing all 20 amino acids, without derivatization, utilizing a carbon LC column.
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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.
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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.
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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.
E-BOOKS
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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.
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In this eBook, scientific experts discuss newer, faster, and more efficacious strategies for peptide mapping and analysis of biotherapeutic products.
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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.
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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.
INFOGRAPHICS
Q&A
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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.
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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.
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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.
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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.
PRODUCTS
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Immerse yourself in a self-guided, virtual tour of an M Lab™ Collaboration Center!
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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.
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Pour them with confidence!
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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.
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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.
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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.
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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.
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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).
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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.