N-nitrosodimethylamine (NDMA) in Ranitidine: The FDA Issues a Nationwide Recall
Background On January 2, 2020, Emery Pharma filed a Citizen Petition (Docket No. FDA-2020-P-0042) with the FDA regarding the drug Ranitidine, which appear to produce unacceptably high levels of a…
Importance of Poloxamer Analysis in Gene Therapy Products
If you are developing a gene-therapy-based product, which requires a Poloxamer quantitation assay and if you are a sponsor of investigational new drug applications (INDs) or applicant of new drug…
Probiotic Dating Game
Probiotics, broadly defined as microorganisms that confer a health benefit when consumed or applied, have become a hot area of research and commercial activity in recent years. This is most…
Reinvigorating Antibiotic R&D?
There has been a growing trend among pharmaceutical and biotech companies to abandon their antibacterial research and development efforts. Big companies like Pfizer, AstraZeneca, Bristol-Myers Squibb, to name just a…
Blood: Sample Analysis
Every drop of blood is a snapshot of our health. From the genetic makeup of our genes we are actively expressing, the concentration of metabolites in our body, to the…
Bioanalytical Assay for Poloxamer Detection
Why is it crucial to develop bioanalytical detection assays for poloxamers? Amphiphilic copolymers have been gaining significant attention due to their ability to simultaneously perform as both a hydrophilic and hydrophobic…
Impact of Climate Change on Antibiotic Resistance
Each year, it is estimated that there are over 2 million antibiotic resistant infections that occur in the United States alone. Of these antibiotic resistant infections, about 23,000 result in…
Chromatography is Full of Ups and Downs!
At Emery Pharma, our team of expert bioanalytical chemists routinely provide R&D support and GLP services for our esteemed clients. Some of the services we provide include: method development, validation,…
A Step-By-Step Guide to 1D and 2D NMR Interpretation
Nuclear Magnetic Resonance (NMR) spectroscopy is an incredibly powerful tool for characterizing molecular structures. When submitting to the FDA or other regulatory agencies, full structural characterization by NMR provides crucial…
A Fascination for the Human Microbiome for a Healthier Life
Trillions of microorganisms live in and on our body. It is estimated that there are 10-100 trillion microbes in a healthy human microbiome, outnumbering human cells by about 10 to…