With recent guidance released from the FDA, there are changes for PKs (Pharmacokinetics) and ADCs (Antibody Drug Conjugates) that must be clearly understood before making decisions for your drug product testing. ADCs combine the target specificity of monoclonal antibodies with the…

Spectral flow has come a long way in recent years, transforming from a mere whisper of possibility to an essential tool in bioanalysis. Initially gaining traction in academic institutions, it quickly caught the attention…

In the ever-evolving landscape of pharmaceutical research…

Biologics are drugs derived from complex molecules like antibodies. Over the last two decades they have re-emerged as…

As with the lineup of equine subjects above, cell populations can take similar forms and act the same in a lot of ways – but to the trained eye, there are clear…

In the world of scientific research and development, certain analytes pose unique challenges that require specialized expertise to overcome. Oligonucleotides, a class of analytes consisting of short DNA or RNA sequences, are notorious for their complexity and demanding nature. With their increasing importance in the…

In recent years, immunology…

Business Wire – May 24, 2023 11:00 AM EST – In an effort to continue…

Clinical research carries significant risks and numerous obstacles that must be overcome to achieve success. Identifying the ideal Contract…

Neurodegenerative diseases affect millions worldwide. Fifty million people are living with Alzheimer’s disease or other dementias. Although Alzheimer’s disease is one of the most recognized, it is just one of many neurological disorders, such as Multiple Sclerosis, Parkinson’s, or Huntington’s disease. These conditions lead to a…

ICH M10 (International Committee of Harmonization Multidisciplinary guideline) provides guidance on bioanalytical method validation and study sample analysis for the measurement of chemical and biological human drugs and their metabolites in biological samples. Such pharmacokinetic/toxicokinetic data serve as the basis for regulatory decisions on the safety, dosage, and…

Being that it is a relatively “niche” segment of the industry, there are several key areas that need to be considered in the field of molecular services related to cell and gene therapies. First and foremost, it is important to recognize that regulatory guidelines within this field are…