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Archive

This is a library of Lhasa's blog articles. 

  • 10 tips 
for controlling 
your potentially mutagenic impurities outside the lab.
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    10 tips for controlling your potentially mutagenic impurities outside the lab

    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.

    30 June 2021

  • A day in the life of a Mirabilis Scientist at Lhasa Limited
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    A day in the life of a Scientist at Lhasa Limited

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

    28 May 2021

  • Collaboration Innovation Working together data sharing
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    Anticipating and supporting the needs of our members

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

    31 July 2020

  • Image for solubility purge best practice blog
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    Lhasa Limited collaborates with industry and regulators to define solubility purge best practice

    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.

    29 October 2020

  • Lhasa Limited supports the global challenge of nitrosamine impurity assessment
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    Lhasa Limited supports the global challenge of nitrosamine impurity assessment

    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.

    13 July 2020

  • Moving with the times; Lhasa’s Cloud offerings
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    Moving with the times; Lhasa’s cloud offerings

    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...

    30 March 2021

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VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

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