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Following reports of immune-mediated conditions and problems with the heart and blood vessels (including fatal cases), the EMA (European Medicines Agency) has started a review of the multiple sclerosis medicine, Lemtrada.
Herewith ACD/Labs presents their web-based software solution to the multiple challenges experienced in screening workflows; offering effective support for high-throughput catalyst screening.
High-throughput mass spectrometry (MS)-based proteomics approaches have developed enormously in recent years and are continuing to do so. The current trend sees proteomics being used by academia and industry to tackle intricate biological questions, often in conjunction with other high-throughput “omics” disciplines such as genomics, transcriptomics and metabolomics. Within the…
The solubility of a compound in organic solvents or water is equally important for screen design and later for process development.
A complete workflow to quantify intact therapeutic proteins in plasma matrix has been developed, covering three critical components in preclinical sample analysis: target protein enrichment/purification, LC/MS data acquisition and quantitative data analysis.
In the biopharmaceuticals industry today, only 13 percent of therapeutics that enter Phase 1 of clinical trials go on to launch1 – and the total journey from R&D to market can be anywhere between eight and 12 years.2
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.
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.
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.
Luminata enables assembly of a complete impurity control strategy for pharmaceutical development...
Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…
PharmaIntegrity makes it quick and easy to identify and trend cleanroom contamination problems before they occur...
Viruses explored through Radiance, an instrument designed to improve the process of analysis, ensures quick and efficient viral detection...
8 August 2018 | By SUEZ
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…
The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand should be proactive, says a leading expert.
