Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated conditions predicting product stability over a long period of time.

Meeting standards for Good Manufacturing Practice (GMP) compliance is increasingly difficult for pharma labs. Regulatory bodies around the globe enforce these standards.

Live-cell imaging enables researchers to study dynamic cellular processes, behaviour and function in real time and over time, giving a more complete and realistic view of biological function.

With the current global pandemic, tests for detecting antibodies against SARS-CoV-2 have become widely available. These tests are used to determine if a person has been exposed to the virus and can suggest whether they have developed immunity.

NDMA was found to be present not only in Valsartan but also in Ranitidine, as an impurity. However, in Ranitidine, it was found to have formed as a part of reaction under high temperatures typically used in GC/MS (Gas chromatography/Mass Spectrometry) technology.

A biomarker, as defined by the National Cancer Institute, is a biological molecule found in blood, other bodily fluids, or tissues that is a sign of a normal or abnormal process — or of a condition or disease. They are analytically measurable, are generally predictive, and have a variety of uses, from determining someone’s risk for stroke to measuring the progress of a disease.

One of the top news topics right now concerns the spread of the highly infectious SARS-CoV-2, which is believed to have begun in Wuhan, China and has since infected hundreds of thousands of people worldwide.

When time is of the essence, it helps to have the right technology on hand. This is especially applicable to labs involved in the development of highly sought-after viral therapeutics and vaccines. These labs require access to high-throughput or ultra-high-throughput screening; viruses, particularly those that have evolved over time, can be quite evasive in their ability to enter and exploit host cells.

IT infrastructure within a pharmaceutical lab is influential in how successful data collection and transfer can be. With the knowledge that data is vital for driving successful drug discovery, your lab’s IT solutions should be used to optimize and accelerate research.

As the effects of the novel virus are felt worldwide, researchers across the globe are mobilizing to find anti-viral therapies to fight against this new infection. Tackling this challenge by traditional de novo drug discovery approaches is a critical piece of the puzzle but also demands time and sizable investments.

Pharmaceutical boards, regulatory agencies, and drug manufacturers work to ensure that they maintain the highest standards for public health and safety.

Within a few weeks of the outbreak, scientists in Wuhan, China were able to isolate and sequence the new highly contagious SARS-CoV-2 viral genome.

More and more researchers are turning to 3D cell models for high-content screening to better understand diseases and to test potential therapeutics.

Finding a best-fit or combination of pre-clinical models in immuno-oncology drug development poses a unique series of challenges. Foundational knowledge of the tumor microenvironment and its evasion of the immune system continues to evolve based on emerging data from areas including regulation, academia, and industry.

Prescription and over-the-counter medicines need to meet the expectations of the public, which requires that they’re safe, effective, and transparent about any possible risks. To do this, there have to be standards and regulations in place that guarantee pharmaceutical quality.

Lab manager are using different staffing models to help reduce costs and accelerate their lab’s workflow.

The complex relationship between a virus and its host is one of the hottest topics in science right now, and has been given considerable attention in recent weeks as a result of the race to understand the virus that causes COVID-19 and its potential vulnerabilities.

Finding the right solution for a lab’s SARS-CoV-2 detection needs can be a difficult decision. The challenges are unprecedented, and the options can be overwhelming. In this presentation at African Healthcare Week, we will discuss the critical factors that labs should consider to help them make a clear choice.

More and more researchers are turning to 3D cell models for high-content screening to better understand diseases and to test potential therapeutics.

Regardless if you are moving one instrument across a campus or 100 instruments across the globe, relocating your lab is never an easy task. We’ve seen it firsthand – poor planning, limited time, and mismanagement can result in a disastrous move.

Regardless if you are moving one instrument across a campus or 100 instruments across the globe, relocating your lab is never an easy task. We’ve seen it firsthand – poor planning, limited time, and mismanagement can result in a disastrous move.

The COVID-19 pandemic has affected nearly every industry, with many measures intended to prevent spread i.e. social-distancing, masks, stay-in-place – remain firmly in place, significantly altering the way life is lived and business is conducted.

NIR is the commonly used term for Near InfraRed spectroscopy, an analysis technique which has been used in the food and agricultural industries since the late 1970s. Over the years it has become very widely adopted worldwide, as it offers signification benefits over the chemical analysis methods it replaces.

NIR grain networking is a well-established concept. The goal of a network is to provide a self-consistent population of instruments such that all instruments produce the same results on the same samples.

High-content screening technology has the potential to accelerate research by extracting huge amounts of information from images of cells, on a cell-by-cell basis.

Time is of the essence when it comes to the development of a vaccine for the infectious disease, COVID-19, caused by the coronavirus SARS-CoV-2. The world has changed due to its impact – and the race to discover a novel vaccine is crucial for our return to normalcy.

Whenever a new instrument is introduced into a pharmaceutical lab, it is normally commissioned through a process of qualification and validation. Depending on a company’s policy, this process is probably based on the most recent USP 1058 or GAMP 5… or a combination of both.

Analysis of incoming excipients and active pharmaceutical ingredients (APIs) is a crucial aspect of a pharmaceutical QA/QC laboratory.

The International Council for Harmonisation (ICH) recently issued the Q12 guideline on technical and regulatory considerations for pharmaceutical product lifecycle management. The guideline has now reached Step 4 of the process.

We’ve all had our blood pressure taken; however, blood pressure measurement isn’t just related to your heart. There is more than one type of hypertension.

Although the novel coronavirus is the subject of nearly every media story right now, several years ago it was the Zika virus (ZIKV) gathering a great deal of attention. Zika stems from the flavivirus family, and is primarily transmitted via Aedes mosquitoes and sexual contact.

The recent Pistoia Alliance Symposium in London focused on the role of Bioinformatics in supporting Precision Medicine. There were some very interesting use cases ranging from principle concepts of bioinformatics to clinical applications to the importance of HPC and cloud for scaling up bioinformatics applications within the clinical setting.

At a recent Bioinformatics Strategy Meeting in Boston, I chaired an interesting roundtable discussion on the potential convergence of translational research and clinical development.

A recent review very succinctly put it that for precision medicine to achieve its aim of “the right drug for the right patient at the right time, may be possible only if the right data come to the right clinic at the right time”.

A few weeks ago I attended the Festival of Genomics in London and amongst the various interesting topics that were discussed the age old question of biomedical data integration featured heavily and still remains a primary (or rather a priority) focus.

Wearing thick gloves and a mask over your face, you attempt to sample the illicit drug using a classic syringe and then test it in your portable GC/MS. It’s a performance art dance of gracelessness and risk.

Time away from the lab is limited and valuable. You need to return from SLAS in San Diego with new tools to raise your scientific research… your “Out of the Office ROI.”

Drug discovery is always evolving. From new processes to advanced technologies, excellence in drug discovery is the result of combining different approaches. And each approach brings a specific answer.

We sat down with expert Chris Strom, former service procurement manager at Bristol-Myers Squibb, to gain some insights into understanding successful vendor relationships and how to decide which procurement model fits your lab.

Lubricant and fuel testing are crucial at motor races such as the International North West 200 motorcycle road race and the Italian Superbike Championship (CIV). When speed, safety, standards, and stardom are at stake, efficient and accurate testing is necessary.

It’s not always easy to figure out whether your software is 21 CFR Part 11 compliant or compatible. Regulations for 21 CFR Part 11 state that electronic records, electronic signatures, and handwritten signatures converted into digital copies are all trustworthy, reliable, and equal to handwritten signatures on paper.

We all like to enjoy our food. Herbs and spices add flavor and aromas to foods in order to entice the senses and build anticipation of an upcoming meal, while products like Manuka honey and extra virgin olive oil provide flavors that are different to conventional commodities.

A lab disaster can come in the form of a fire, tornado, loss of electricity, cyber attack, compromised assay components, or more. With profitability and results on the line, many pharma labs are taking steps to develop disaster prevention strategies as well as carefully thought-out response plans.

Hybrid approaches to lab management are now becoming the norm, globally, with the lure and benefit of promising a more efficient, optimal operation within labs – including reducing undue burden on lab managers.

When most of us encounter bacteria, we reach for a sanitizer. Researchers at the Cork Cancer Research Centre in Cork, Ireland, have a much different reaction. They view these single-cell microorganisms as literal torchbearers in advancing new therapies for infectious diseases especially as it relates to cancer.

While Shakespeare’s Hamlet pondered the existential question “To be or not to be?” the quality control director’s most pressing concern is undoubtedly “To trust or not to trust?” That’s really the question!

A recent article in Chemical & Engineering News (June 4, 2018, pp 28-33) focused on activities in immuno-oncology, where biologic checkpoint inhibitors are being tested in combination with other immunotherapies: there are currently ca. 250 small molecule- and antibody-based immunotherapies in clinical studies, and > 1100 clinical trials in 2017 combined a checkpoint inhibitor with another treatment.

Before becoming Product Manager for ChemDraw®, Pierre Morieux was working as a Field Application Scientist and conducted countless training sessions for numerous customers across the globe.