Whitepaper: Logistic regression model of the endotoxin standard curve and statistical tests
The Monocyte Activation Test (MAT) is used to detect or quantify pyrogenic substances that activate human monocytes.
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Whitepapers & App Notes
Application Note: Microbiological considerations in cleanroom validation
Contamination, microbiological or otherwise, is a key safety concern in the development and manufacture of all pharmaceuticals and medical devices.
Whitepaper: A high-quality Raman microscope can be recognised by these five criteria
90 years ago Chandrasekhara Venkata Raman and Kariamanickam Srinivasa Krishnan first documented "A New Type of Secondary Radiation," which then became known as the Raman Effect [1, 2]. Raman spectroscopy is based on this effect and is used for qualitative and quantitative analysis of the chemical components and molecules of…
Application Note: The future of water is clear
Taking advantage of technology developed in recent years, MECO announces smartANALYTICS™ as a means of connecting its water purification machines and systems with big data analytics and in-house expertise.
Application Note: Focus on the fundamentals
Fundamentals. The drab cousins of the headline grabbers like AI or Pharma 4.0. But focusing on them can be the investment that offers the most long-term rewards for companies in terms of risk mitigation, cost reduction and improved overall agility. In pharmaceutical packaging and labelling, the key fundamental is the…
Application Note: Verification of three different Opadry whites using a handheld Raman analyser
Pharmaceutical companies that manufacture tablets, capsules, and other solid dosage forms use film coatings on their products to differentiate appearance and to improve palatability by masking unpleasant tastes or odors.
Application Note: Biologic drug identification at fill and finish
The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.
Application Note: Quality manufacturing solution – interfacing with third-party systems
Most organisations that are looking to implement a new LIMS or replace an aging one have a significant investment in a number of information systems.
Whitepaper: Are you facing a complexity crisis?
I spend a lot of time in bland hotels and rarely remember any of them… except one. This particular hotel will, forever, remain etched on my mind because of the complexity of its toilets.
Application Note: Transforming your bioanalysis operations
Many bioanalytical labs work with a crowded and siloed set of systems and processes. From part electronic to part paper-based workflows, to standalone point-solutions, the result is a lack of insight into data and slower reporting and results handling.
Whitepaper: Characterising antibody-drug conjugates using micro pillar array columns combined with mass spectrometry (μPAC™-MS)
The use of micro pillar array columns (μPAC™) for characterising antibody-drug conjugates is presented. Kadcyla® (ado-trastuzumab emtansine) and, for comparison, Herceptin® (trastuzumab) tryptic digests were analysed on a 200 cm μPAC™ C18 column and peaks eluting were detected by ultraviolet (UV) spectroscopy and high-resolution mass spectrometry (MS).
Whitepaper: The importance of data integrity in current regulation
With the advent of new technology, data integrity−meaning data that is accurate, complete and repeatable−is even more essential to a product's quality and public safety.
Whitepaper: Big Data in pharmaceuticals – big opportunities or big challenges or both?
Big data covers every facet of our working life. Every aspect of pharmaceutical research and development involves the generation of huge quantities of data, with the expectation that we can turn this information rapidly into useful knowledge, which in turn can be used to make ‘data-driven’ decisions to better understand…
Application Note: Real time, low flow, pharmaceutical soil cleanability profiling with TOC and conductivity
Designing a robust cleaning process for pharmaceutical drug manufacturing is critical to successful cleaning validation and verification.
Application Note: Representative sampling of solids and turbid media in process raman spectroscopy
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation. As a measurement technique, Raman imparts many benefits in applications from laboratory discoveries to feedback-control in manufacturing.
