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