MEET US 2023

News

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 (...)

VICH GL18 (R2): Changes in Residual Solvents for Veterinary Products

As stated by the EMA (European Medicines Agency), residual solvents are organic volatile chemicals used or produced during the manufacture of active substances or excipients, as well as in the preparation of veterinary medicinal products. (...)

Diethylene Glycol and Ethylene Glycol testing on high-risk drug components

Following several global incidents involving contaminated drug products specifically designed for children, the U.S. Food and Drug Administration (FDA) released a guidance document in May to address the potential danger of diethylene glycol (DEG) and (...)

Advanced Therapy Medicinal Products: First platform for adeno-associated viruses in gene therapy

In a significant step towards enhancing the field of gene therapy, Kymos has joined forces with the VIRAL VECTOR PRODUCTION UNIT—a collaboration between the Autonomous University of Barcelona and the Vall d'Hebron Research Institute. Together, (...)