News
Liraglutide & Semaglutide: Exploring Biosimilar Studies for GLP-1 receptor agonists
Liraglutide and Semaglutide have become key players in the pharmaceutical and healthcare industry as they are both being used and have been approved not only as an anti-diabetic medication but also as an obesity and (...) Read more
Impurity Profiling: Characterization of unknown impurities in pharmaceuticals
Characterization of unknown impurities found in pharmaceutical substances and pharmaceutical products is a vital part of the regulatory approval process. According to ICH guidelines, if the estimation indicates an impurity content higher than 0.1%, it (...) Read more
U-Shape and Lean Lab: Improving productivity in the laboratory
The landscape of the life sciences ecosystem is ever-changing, and laboratory operations continually adapt to meet market demands, with efficiency and productivity crucial to the industry's evolution. Among the key drivers of this transformation are (...) Read more
FDA New Guidance: NDSRIs Recommended Acceptable Intake Limits
The US Food and Drug Administration (FDA) has taken a significant step to address the mutagenic and carcinogenic risk associated with Nitrosamine Drug Substance-Related Impurities (NDSRIs). This past August, the FDA introduced a final guidance (...) Read more