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Quality-driven solutions from discovery to commercialisation
Find out how SGS’s high-quality analytical testing solutions could benefit all phases of your drug development programmes, from discovery through commercialisation.
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SGS Life Sciences
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Whitepaper: Standard versus “hybrid” FIH trial advantages and challenges
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.
whitepaper
Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
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Technical bulletin: An updated approach to E&L testing per ISO 10993-18:2020
ISO 10993-18:2020 outlines the chemical characterisation tests that manufacturers must undertake to support the biological safety of their medical devices.
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Technical bulletin: Nitrosamines: Questioning the current analytical approach
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.
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Quality driven solutions from discovery to commercialisation
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…
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SGS experts help to mitigate the risk of nitrosamine impurities in drug products
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.
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Article: Analytical Quality by Design (AQBD) approach to support analytics optimisation strategy
Analytical procedures are necessary to develop products and manufacturing process, to measure critical quality attributes and to ensure the quality of final products.
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SGS’s Centre of Excellence for Biosafety contributes to the fight against coronavirus
Developing new vaccines to fight emerging diseases is an ongoing fight and ensuring they are pure is vital to patients’ health and safety.
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SGS joins Oxford University consortium led by the Jenner Institute to develop COVID-19 vaccine
In a consortium led by the Jenner Institute, Oxford University, SGS has joined forces with specialists in infectious diseases, research and innovation, and pharmaceuticals to rapidly develop, scale-up and produce a potential vaccine called ChAdOx1 nCov-19.
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SGS digicomply launches COVID-19 INTEL
An ai platform for teams on the pandemic research frontline.
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Nitrosamine detection: Meet EMA and FDA regulations
In 2018, the presence of the nitrosamine N-nitrosodimethylamine (NDMA), a potential carcinogen, in certain sartan active pharmaceutical ingredients (APIs) resulted in several regulatory warnings and recalls of contaminated products.
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SGS biosafety laboratory offers gmp compliant vaccine testing solution for coronavirus
SGS's Center of Excellence for biosafety can help contribute to the fight against coronavirus.
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Brochures: Extractables & leachables services
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
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Whitepaper: Detection of mycoplasma in biopharmaceuticals vaccines and gene cell therapies
Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane.