Nitrosamines are emerging as a significant concern in the pharmaceutical industry, posing regulatory and safety challenges for manufacturers. Are you prepared to address these risks effectively? Our panel of expert speakers discussed why nitrosamines have become a growing concern and the latest regulatory developments in Argentina and Mexico. This webinar also introduced innovative in silico […]
Nitrosamines on the horizon: Are you ready? Read More »
We were delighted to be on the programme at the 10th Winter Process Chemistry Conference. Lhasa Principal Scientist Michael Burns presented ‘Reactivities of N-nitrosamines against Common Reagents and Reaction Conditions’. The 10th Winter Process Conference showcased presentations from International Chemists covering all aspects of Process Development. The speakers discussed the latest issues in synthetic route design,
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Japan The 53rd Annual Meeting of the Society of Environmental Mutagen Genomics (JEMS) was held for two days on Saturday, December 7 and Sunday, December 8, 2024 at Shuji University (Okayama City). We were thrilled to participate in the annual conference of the Japanese Environmental Mutagen and Genome Society (JEMS). Since its inception in 1972,
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We were delighted to be on the programme at the 4th Annual Genotoxic Impurities Summit. Lhasa Principal Scientist Michael Burns presented ‘Reactivities of N-nitrosamines against Common Reagents and Reaction Conditions’. Impurities may have a negative effect on the efficacy, safety, and quality of pharmaceutical components and products. The successful development and manufacturing of novel medications now
4th Annual Genotoxic Impurities Summit: Nitrosamines & Beyond 2024 Read More »
We were delighted to be on the programme at the Annual Meeting of the Japan Society for Alternative Methods of Animal Experimentation (JSAAE), held at Light Cube Utsunomiya for three days from November 29 – December 1 2024. The Japan Society for Alternative Methods of Animal Experimentation is an academic organization that conducts research, development,
Managing impurities in Active Pharmaceutical Ingredients (APIs) while meeting ICH M7 can be challenging. The need to quickly identify potential impurities, assess their toxicological risk and ensure compliance with mutagenicity and carcinogenicity guidelines demands a streamlined, reliable process. Held in Spanish, this webinar showcased how in silico tools Zeneth, Derek Nexus, and Sarah Nexus can
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10 am (EST) / 3 pm (GMT) / 4pm (CET) This webinar detailed how to develop control strategies in line with ICH M7 guidelines without expensive and time-consuming analytical testing. We showed how you can assess carryover risk for potentially mutagenic impurities (including nitrosamines) in your drug development workflow. We were delighted to have Senior
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We were excited to attend the American College of Toxicology (ACT) 2024 annual meeting in Austin, Texas! ACT is a global community of professional scientists representing the pharmaceutical and biotech industries, regulatory agencies, contract research organizations, academia, and consulting firms. The 45th Annual Meeting included a wide-ranging scientific program and educational courses, with distinguished plenary
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We were excited to attend the Extractables & Leachables Europe 2024 conference, held in Vienna, Austria. Supported by ELSIE, this conference was dedicated to discussing extractables and leachables examination as the importance of this area continues to grow. Given the current scrutiny paid by governing bodies including the FDA and MHRA, understanding the best practice
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We were delighted to take part in an online seminar and panel discussion with ThermoFisher Scientific on 29th October. Nitrosamine Drug Substance related impurities (NDSRIs) remain a topic of significant concern to the pharmaceutical industry with multiple batch recalls in 2022+ across different drug classes including beta blockers and ACE inhibitors to name but a
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