Stability testing is an essential part of drug development as it ensures the efficacy and safety of the medicinal product throughout its shelf life. It allows the evaluation of APIs and drug product stability under the influence of various environmental factors that will enable us to determine their behavior and changes over time. Being such (...) Read more
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 must be identified and characterized ensuring compliance with all regulatory requirements. This process is also known as impurity profiling. The (...) Read more
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 the adoption of methodologies like the Lean Lab principles and U-shape layout methodologies. These philosophies and strategies stand as vital (...) Read more
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 framework that not only predicts the risks but also sets recommended acceptable intake (AI) limits for NDSRIs in drug products (...) Read more
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. These solvents are not completely removed by standard manufacturing techniques and can pose risks to the target animal and consumers (...) Read more
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 ethylene glycol (EG) contamination in different pharmaceutical components. These incidents occurred across seven countries between 2022 and 2023 and have (...) Read more
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, we are embarking on a project to study and develop a state-of-the-art technological platform for gene therapy assays, focusing specifically (...) Read more
ICH M10 is the new guide for the validation of bioanalytical methods which was adopted by ICH last year and has been implemented by EMA in January 2023. Our Bioanalysis department, working with the Quality Assurance Unit, has adapted their LC-MS/MS methods to the new guide, and starting from that date, their validation studies and (...) Read more
Cannabis and its medicinal use have long been discussed among the medical community and have been repeatedly called for by patient associations. However, cannabis was illegal in many countries and classified as an abuse drug. In recent years, the perspective on cannabis has changed and in 2015 the FDA eased the regulatory requirements to allow (...) Read more
In addition to Kymos, which has been CIR certified for quite some time, our German subsidiary Prolytic has been approved a CIR certification as well. Now your R&D activities (from Early Phase up to Phase IV projects) performed at Kymos and Prolytic are eligible to CIR. You can recover up to 30% of the amount (...) Read more
