We are delighted to share our important new open access article: In silico prediction of pharmaceutical degradation pathways: A benchmarking study using the software program Zeneth. The paper, recently published in Organic Process Research & Development (OPRD) is authored by Lhasa Principal Scientist Rachel Hemingway, alongside industry expert co-authors from AstraZeneca, GSK, Pfizer, BMS, Amgen […]
Ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) is of paramount importance. A critical aspect of this process involves the identification and mitigation of potentially mutagenic impurities, like nitrosamines. In this blog, we will explore the significance of risk mitigation at the early stages of API development and introduce a cutting-edge solution, Zeneth,
Safeguarding Pharmaceutical Development: The Importance of Early Risk Mitigation Read More »
“When you are innovating, ultimately it comes down to how that innovation is used by the end user… Where does the problem really lie before you dive in and propose a technology solution?” Peter Bannister, Technology Advisory Community Consultant at Endava. Here at Lhasa, we take this concept to heart. Our focus extends beyond creating
The importance of sharing knowledge for innovation Read More »
Unreported changes to synthetic processes lead to the surprise presence of nitrosamine impurities in marketed drug products. This discovery resulted in the recall of several hypertension, heartburn, and diabetes medications. The nitrosamines crisis While many impurities are introduced directly as reagents, potentially mutagenic impurities (PMIs) arising during manufacture can be harder to identify as they
How well do you know your synthetic process? Read More »
Revised guidance released by the European Medicines Agency (EMA) on 7th July sparked excitement within the scientific community. By unveiling a new system to classify nitrosamines, EMA demonstrates that regulators are supporting industry in solving the complex problem of nitrosamine impurity assessment. The new approach will benefit industry, regulators and ultimately patients. What exactly are the
What does the EMA update on nitrosamine impurities mean for you? Read More »
We recently attended GirlTechLeeds, to help inspire the next generation of women in Tech! At Lhasa, we believe that it is important to create an environment where everyone can succeed, which is why our amazing colleagues volunteered their time to attend the event and share their knowledge and experience of working in a tech role. On
Uniting with the Leeds tech sector to help young women discover careers in digital Read More »
We are delighted to share our vital new article ‘Establishing best practice for the application and support of solubility purge factors’ which was recently published in Organic Process Research & Development (OPRD). The paper has been written by Lhasa Principal Scientist Michael Burns, alongside industry expert co-authors from AstraZeneca, GSK, Hoffman LaRoche and other forward
Establishing best practice for impurity purge by solubility Read More »
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