This whitepaper provides an overview of the regulatory challenges posed by the detection of nitrosamine impurities in pharmaceutical products.
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SGS Life Sciences
No matter the industry, collaborations between multiple parties throughout a project pipeline can prove challenging.
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
Press release: SGS launches SGS PACE, a streamlined pathway through preclinical, formulation, FIH and POC
SGS PACE is a seamless combination of world-leading development, bioanalysis and clinical research through one point of contact.
SGS’s biosafety centre of excellence in Glasgow has received the Business Leadership Award at Scotland's Life Sciences Annual Awards 2023.
SGS have relocated their biopharmaceutical testing laboratory in Plan-les-Ouates, Switzerland.
Innovations in the use of viral vectors as a gene delivery vehicle are a key factor in the growth of the gene and cell therapy field.
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
This whitepaper examines key considerations to take into account when deciding whether to run a standard FIH in HVs or a hybrid FIH clinical trial.
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
We look at the challenges posed in regards to nitrosamine testing methodologies and the way in which to move forward to ensure safer drug products.
We offer high quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation. Find out more in this guide…
The identification of N-nitrosodimethylamine (NDMA) in an active pharmaceutical ingredient (API) in 2018 not only led to regulatory warnings and product recalls, but wider recognition that pharmaceutical manufacturers should adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.