whitepaper
Whitepaper: Solubility: Importance, measurements and applications
The solubility of a compound in organic solvents or water is equally important for screen design and later for process development.
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Data Analysis
whitepaper
Application Note: Quantitation of intact therapeutic protein in plasma matrix by LC/MS
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.
article
The data challenges of research & development and collaboration
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
product
Product Hub: High sensitivity pyrogen testing with the PyroMAT™ system: make the move to the next MAT generation
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.
whitepaper
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.
whitepaper
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.
product
Anne Marie details the benefits of ACD/Labs’ Luminata
Luminata enables assembly of a complete impurity control strategy for pharmaceutical development...
article
Integrating data from QC and Production to enable fast, informed decisions
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…
news
Holistic approach to data management for pharmaceutical manufacturers
PharmaIntegrity makes it quick and easy to identify and trend cleanroom contamination problems before they occur...
news
Radiance could be the key to faster viral detection
Viruses explored through Radiance, an instrument designed to improve the process of analysis, ensures quick and efficient viral detection...
webinar
Understanding current CFR 21.11 and data integrity requirements
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…
news
Pharmacovigilance of new drugs ‘should be more proactive’ in New Zealand
The pharmacovigilance of new drugs and drug formulations undertaken in New Zealand should be proactive, says a leading expert.
news
Heart health calculator predicts CVD risk
A new online heart health calculator can predict the age of hearts and the risk to individuals of a serious cardiovascular event or death...
news
Direct anticoagulants associated with increased risk of bleeding
Results of a study suggest the need for caution in the prescription of direct oral anticoagulants for patients with chronic kidney disease, due to the risk of bleeding...
product
Product Hub: Creating centralised control for a decentralised approach
Maintaining the long-term safety of a manufacturing environment while meeting the demands of compliance is a microbial quality control manager’s top priority...
