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The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
The Monocyte Activation Test (MAT) is used to detect or quantify pyrogenic substances that activate human monocytes.
Sophisticated hardware and software offer speed and precision. Pharmaceutical development often involves samples in solution or on transparent substrates. For these applications, confocal Raman imaging using an inverted beam path is an especially versatile and powerful investigative method.
The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…
Used to detect a broad range of pyrogens in parenteral products including pharmaceuticals, biopharmaceuticals and medical devices, the Monocyte Activation Test (MAT) gives an in vitro alternative to conventional animal testing in accordance with regulatory guidelines.
This In-Depth Focus covers drop-coating deposition Raman (DCDR) spectroscopy for metabolite profiling and recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines.
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
Researchers have identified markers of pediatric acute lymphoblastic leukaemia to predict early relapses by testing levels of nucleotide excision repair...
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination...
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...
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.
SOLu-Trypsin is an Advanced Proteomics Grade enzyme that is solution stable for mass spectrometry.
Instrument agnostic consumables available for an HPLC or LC-MS workflow lab.
Cross checking your HPLC method for impurity profiling with TLC.
