Articles in this Issue
Scott Sutton, Ph.D.
It seems self-evident today, but worth remembering, that the pharmaceutical industry exists on a foundation of trust. Patients or even doctors have no way to actually determine the strength, purity and quality of the medicines prescribed and taken. Everyone trusts that the label is accurate and the medicines are pure. This was not always the case and efforts to safeguard our medicine supply led
directly to USP, FDA and the GMPs.
Jason Creasey, Vincent Thibon, Ph.D.
Regulatory agencies are increasingly requesting a more comprehensive evaluation of the potential contamination of biopharmaceuticals from leachables both from the container closure system used to store the biopharmaceutical and other possible sources such as the manufacturing system. To meet this demand, Total Organic Carbon (TOC) has been investigated as a possible technique that can be used to assess leachables from biopharmaceutical manufacturing equipment and thus provide data to assess the potential risk that biopharmaceutical manufacturing leachables pose to patient safety and product quality.
Sulaf Assi, Ph.D.
Raman spectroscopy has emerged as a rapid and powerful tool for critical applications in forensic science. The advantage of Raman spectroscopy
is that the Raman signal is often selective to pharmacologically active drug substances [1, 2]. On the other hand, pharmacologically inactive substances do not exhibit a Raman signal and their spectra are often masked by fluorescence. This could be advantageous in identifying drug substances, especially new psychoactive substances.
Zhenyu Wang, Ph.D., Honggen Zhang, Oscar Liu, Ph.D., Brent Donovan, Ph.D.
In the past decade, packed column supercritical fluid chromatography (SFC) has dominated chiral separation and chiral purification in medicinal chemistry and process chemistry in the pharmaceutical industry. However, SFC is not just limited to chiral separations. It is getting more and more attention in the arena of achiral separation,
which has been dominated by reversed-phase liquid chromatography (RPLC). Compared to well-established RPLC, SFC provides higher separation efficiency and faster analyses while offering low operation cost and facile tunable selectivity for method development.
Ralph Lipp, Ph.D.
Innovation focused on addressing unmet medical need and improving outcomes for patients is one of the central and overarching goals of the life sciences sector, with significant contributions from large biopharmaceutical companies, biotech and specialty pharma companies, drug delivery companies, and academia. For decades the
creation of new medicines has increased quality and quantity of life for patients around the globe. Just looking at the past decade reveals great
progress on various fronts, including a 40% reduction of cardiovascular deaths in the US, a significant increase of life expectancy of HIV
patients, and the advent of cancer medicine–diagnostic combinations, among others [1]. Scientific breakthroughs leading to novel and
valuable medicines are benefiting both patients and their caregivers, and ultimately, society.
Michael Zemo
Our guarantee is backed by a commitment to efficient automation and the precision engineering that goes into each and every instrument.
METTLER TOLEDO’s high sensitivity sensor technology, full-range microbalances in TGAs, and time-saving, reliable autosampler capabilities are a few examples of qualities that provide a high-level of overall satisfaction to our customers.