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Ensuring the safety of active pharmaceutical ingredients (APIs) is of great importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. Our in silico tool Zeneth has been used within exploratory formulation departments to understand and account for potential degradation problems within the API at an early stage, resulting […]

We were delighted to host a webinar in Japanese, titled ‘How to predict for the formation of NDSRIs’. Nitrosamine Drug Substance-Related Impurities (NDSRIs) have become a major concern in the pharmaceutical industry due to their potential to pose serious health risks to patients. Understanding how to predict and manage the formation of NDSRIs is vital

This enlightening event brought together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitisation potential of extractables and leachables (E&Ls). Featured presenters and ELSIE consortium members included: Patricia Parris, Global Risk Assessment Services Toxicologist at Pfizer Geraldine Whelan, Regulatory Toxicologist at GSK Martyn Chilton, Principal

Performing ICH M7 risk assessment for process impurities and degradation products was targeted towards Latin America and carried out in Spanish. In this event, we explored how our software solution, Zeneth, can help you to identify potential degradation impurities in your drug development workflow. We also demonstrated how to classify potentially mutagenic impurities through our

Join us for our webinar, Streamlining your drug development workflow using purge calculations. This webinar was hosted in Japanese and contained pre-recorded videos with Japanese subtitles. We were delighted to have Senior Principal Scientist Andy Teasdale, presenting in this webinar. Andy is currently the chair of AstraZeneca’s Impurity advisory Board, and has developed a wealth

The safety, quality and clinical results of drug substances and drug products may be disrupted by the formation of nitrosamines along with other mutagenic impurities. The comprehensive development and production of innovative medicines now inevitably involves estimating impurity profiles as well as managing and monitoring them. To meet the demands of ever-increasing regulatory standards and

Nitrosamine Drug Substance-Related Impurities (NDSRIs) have become a major concern in the pharmaceutical industry due to their potential to pose serious health risks to patients. Understanding how to predict and manage the formation of NDSRIs is vital to ensure the highest quality and safety standards are met in drug development and manufacturing processes. In this

We were thrilled to be joined by a distinguished panel of experts to discuss how to establish acceptable intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). NDSRIs have emerged as a significant cause for concern within the pharmaceutical industry due to their potential to pose serious health risks to patients. In order to facilitate

Join us for our upcoming webinar ‘Leachables sensitisation assessment framework in collaboration with ELSIE’. This enlightening, pre-recorded event will bring together esteemed members of the Extractables and Leachables Safety Information Exchange (ELSIE) consortium for a captivating discussion on the sensitization potential of extractables and leachables (E&Ls). Featured presenters and ELSIE consortium members will include: Patricia

Lhasa Principal Scientist, Rachel Hemingway, presented; Use of an in silico tool to determine the molecular susceptibility of compounds forming nitrosamine degradation products, as part of FreeThink Technologies Nitrosamine webinar series. In the webinar, Rachel addressed: How can an in silico tool help with nitrosamine assessments?  What chemical space is covered?   Case studies: NDSRIs  How can a