SGS

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.

This case study will examine the subject of single-use plastics used in biopharmaceutical manufacturing and extractables & leachables from the perspective of the contract research organization.