Traceability And Compliance: The Keys To A Safe And Efficient Lab

INSIGHTS on TRACEABILITY AND COMPLIANCE

• UHPLC Analysis Of Vitamin D2 & D3

  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.

• Webinar On-Demand: Substitution Of Hazardous Substances

  Substitution is the essential starting point in every risk assessment. Learn how to conduct a legally compliant substitution check using real substances as examples.

• Improved Karl Fischer Titration Analyses And Regulatory Compliance

  For various industries and materials, exact water determination is necessary. Here, we cover water determination by Karl Fischer titration, the Karl Fischer titration process and methods, quality assurance, and more.

• Detection Of Endotoxin And Non-Endotoxin Pyrogens By MAT

  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.

• Making Sense Of Analytical Standards In Pharma QC

  Reference materials are a critical component of the analytical testing workflow. Here, we offer information on metrological traceability, the hierarchy of reference materials, fit-for-purpose selection considerations, and more.

• Risk Considerations For The Presence Of Pyrogens And The Need For The MAT Test In Pharmaceutical Processing

  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.

• Expert Insights On Pharma Analysis & QC

  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.

• Evaluating Pyrogen Contamination Risk And The Need For The MAT In Pharmaceutical Processing

  The measurement of pyrogens is an important safety measure for parenterally administered drugs. Here, we explore several advantages the Monocyte Activation Test (MAT) provides over the rabbit pyrogen test.

• How To Implement Our PyroMAT® System

  Shift from animal-based pyrogen testing to in vitro testing with the implementation of the only cell-line based pyrogen test that mimics the human immune reaction.

• Robotics & Automation On The Brink Of Transforming Pharma QC

  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.

• Selecting The Right Media For Your Aseptic Process Simulations

  Media fill experts from MilliporeSigma provide an overview of what to consider when selecting media for aseptic process simulations, particularly regarding regulatory requirements and user requirement specification (URS).

• Assess Pyrogenic Risk In Pharmaceutical Process With The Monocyte Activation Test

  Microbial risk in pharmaceutical processing cannot be limited to viable microorganisms. Learn how the MAT can help you to assess the pyrogenic risk resulting from your production process.

• Suitability Of The Mono-Mac-6 Cell Line For The Detection Of Endotoxins And Non-Endotoxin Pyrogens

  The ability of the Mono-Mac-6 cell line to detect non-endotoxin pyrogens is sometimes questioned. To demonstrate its performance, tests have been performed using a wide panel of monocytic TLRs ligands.

• Monocyte Activation Test: The In Vitro Pyrogen Test For Pharmaceutical Batch Release

  The monocyte activation test (MAT) provides an in vitro alternative to conventional animal testing methods. Discover the benefits of a ready-to-use Monocyte Activation Test kit, and examine a real-life case study.

TRACEABILITY AND COMPLIANCE SOLUTIONS

• The Full Range Of Mycoplasma Culture Media

  Three media, Friis, Frey, and Hayflick, are used to detect different ranges of mycoplasmas. MilliporeSigma offers all three as ready-to-use, with longer shelf-life broth and plates for compendial testing.

• RP-HPLC Columns For Proteins And Peptides

  In proteomics and biopharmaceutical research, there is a need to obtain as much information as possible on limited sample amounts. Discover reversed-phase solutions to protein and peptide separation challenges.

• The In-Vitro Monocyte Activation Test (MAT): Compendial Replacement For The Rabbit Pyrogen Test

  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).

• Detection Of Endotoxin And Non-Endotoxin Pyrogens By Monocyte Activation Test (MAT)

  Performing endotoxin testing? Trust your data with a Monocyte Activation Test that mimics the human immune reaction and detects both endotoxins and non-endotoxin pyrogens.

• Secure Your Pharma Analysis & QC

  Explore an extensive analytical chemistry and microbial testing compliant portfolio for pharmaceutical analysis and quality control (QC) from early-stage drug development to product release.