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N-Nitrosamine risk assessment and control have become an integral part of pharmaceutical drug product development. In this article, we discuss 3 key stages of risk assessment: identifying the source of risk, determining the level of activity and mitigating the risk. Discover how our in silico tools can be used to support informed decision making on chemical safety, in this blog article.

A key consideration within drug substance synthesis is the potential presence of mutagenic impurities. Potentially mutagenic impurities (PMIs) often arise from reagents which are essential for the synthesis of a final active pharmaceutical ingredient (API) meaning that the risk is therefore often unavoidable. As a result, there is a need to assess the risk posed by mutagenic impurities.
To discuss this topic in more detail, we were delighted to welcome Andrew Teasdale PhD and Muzaffar Khan PhD, to present at our webinar; Controlling potentially mutagenic impurities - hear from industry experts!

In case you missed this event, we have summarised the top eight take away tips from the webinar, for quick and easy consumption within this article. 

Many readers will be aware of the risk posed by nitrosamine impurities, as an ongoing pharmaceutical industry hot topic. In July 2021 ANVISA published their guidance for assessment and control of potentially carcinogenic nitrosamines in active pharmaceutical ingredients and drug products. To discuss this topic, we invited knowledgeable speakers from ANVISA, Industry - GSK and Libbs Farmacêutica - and Lhasa to give their perspectives on this topic. This article details the top 20 take away points from the workshop for quick and easy consumption - enjoy!

Many readers of this blog will be aware of the threat posed by potentially mutagenic impurities within drug substance synthesis. Such impurities often arise from reagents which are critical to the synthesis therefore this impurity-related threat is unavoidable.

As such, there is a need to assess the risk posed by mutagenic impurities.

Discover a day in the life of a Mirabilis Research Scientist at Lhasa Limited! 

In a world where we are all striving for progress, technology is also advancing quickly.

Like many organisations across the life sciences industry – evidenced by the 82 Amazon Web Service (AWS) life sciences case studies -  Lhasa has adopted cloud, Software as a Service (SaaS), options across three notable areas...

Key to the regulatory acceptance of purge arguments is the conservatism within the purge factor scoring system, which for reactivity purge has been demonstrated across a number of publications and is consistently implemented across the pharmaceutical industry through the development of a collective understanding of and how they should be applied.

Likewise, when volatility purge scoring is relatively simple to understand and apply, particularly using the scoring thresholds originally proposed by Teasdale et al.

However, through our interactions with Mirabilis users, regulators, and other members of the purge community, it has become increasingly apparent that the same cannot be said of solubility purge scoring. Lhasa have therefore identified the huge value to the community of developing an accepted best practice, incorporating both the application of solubility purge scoring and, where appropriate, provision of a clear justification of the purge factor assigned.

As a member-based organisation, anticipating and supporting the needs of our members is critical. 

The recent discovery of N-nitrosamine (nitrosamine) impurities in several marketed pharmaceuticals has led to a requirement for further investigation into nitrosamine mutagenic and carcinogenic activity. Regulatory requirements mean that marketing authorisation holders for human medicines, containing chemically synthesised active substances, must review their medicines for the possible presence of nitrosamines and test all products at risk. Risk-based approaches to prioritise evaluations and subsequent confirmatory testing may be used. These assessments must be completed by October 2020, generating a significant challenge for the pharmaceutical industry.