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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

This virtual event explored how our in silico software solution Zeneth can help you identify forced degradation pathways of organic compounds, which can support characterization of structures of degradants. Real life case studies demonstrated how this can be applied to analytical development, formulation and nitrosamine risk assessment. Principal Application Scientist, Margarita Munoz-Henao discussed the benefits

Thank you to those who attended our webinar, ‘Streamlining your drug development workflow using purge calculations’. We were delighted to have Senior Principal Scientist Andy Teasdale presenting . Andy is the chair of AstraZeneca’s Impurity advisory Board, and has developed a wealth of knowledge over the last 30 years working in the pharmaceutical industry. He

We recently held our webinar ‘Harnessing cutting-edge carcinogenicity data to support your toxicity assessments’. In this free to-attend virtual event, Lhasa Senior Scientist, Andrew Thresher presented the latest innovations in the Lhasa Carcinogenicity Database (LCDB). The LCDB is a freely available database of in vivo carcinogenicity study information, which includes TD50 values as a measure

In this Lhasa webinar we discussed alternative approaches to carcinogenicity assessment with Dr. Todd Bourcier (FDA) and Dr. Gina Hilton (PETA). Within many sectors of the life sciences industry, animal testing is still considered a primary option for toxicity testing, and as a result is used heavily. The limitations of this model are now well