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Insights into the 2024 Science of Stability Conference

Following the success of the 2022 Science of Stability (SOS) Conference in Philadelphia, we’re excited to announce its return to Barcelona! The 8th SOS will take place on the 13-14th May 2024, and we’re delighted to co-host it with FreeThink Technologies. With a focus on innovation and collaboration, this promises to be a milestone event …

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Have you read this? Benchmarking In silico prediction of pharmaceutical degradation pathways

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 …

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Safeguarding Pharmaceutical Development: The Importance of Early Risk Mitigation

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, …

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Mitigating the risks of NDSRI’s through data sharing

At Lhasa, we believe in the transformative power of knowledge sharing as the driving force to support the global challenge of nitrosamine risk assessment. Through data sharing and industry collaboration, we empower members to further understand the risks associated with their potential nitrosamine impurities. The Vitic Complex Nitrosamines initiative, launched in 2021 in response to …

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The importance of sharing knowledge for innovation

“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 …

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NIHS collaboration: revolutionising chemical safety assessment and reducing animal testing reliance.

NIHS collaboration: revolutionising chemical safety assessment and reducing animal testing reliance

Have you read our collaborative paper, published with the National Institute of Health Sciences (NIHS) of Japan? The paper is based on our shared project to improve in silico developmental and reproductive toxicity (DART) predictions, to safely move towards replacing traditional animal testing for chemical safety assessments. “The outcome of this collaborative and innovation project …

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How well do you know your synthetic process?

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 …

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What does the EMA update on nitrosamine impurities mean for you?

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 …

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