SGS

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

SGS has developed a network of centers of excellence for Nitrosamine testing across all regions to better serve our clients. Our experts specialize in method development solutions to identify and quantify all nitrosamine contaminants, including the challenging nitrosamine drug substance related impurities (NDSRIs).

This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.

There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products. In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities. Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.

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. However, the long-term impact of viral vectors requires continued research in their design to address both efficacy and the problems with immunogenicity and toxicity.

This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.

This whitepaper will look at how integrating the SEC-MALS method at an earlier stage in the development process will accelerate speed-to-clinic without compromising patient safety.