The future of regulatory compliance and track and trace

In the rapidly expanding arena of biotherapeutic analysis and bioprocess development, the analysis of host cell proteins (HCP) is transitioning to a new phase. HCPs are contaminants in biotherapeutic drug preparations, often at low ppm concentration levels, and must be monitored due to stability, efficacy and immunogenicity concerns. Often, these protein impurities will be considered Critical Quality Attributes (CQA) and can contribute to an overall risk assessment for the product.

The drug R&D pipeline in 2019, and how it is changing

Sexually transmitted infections (STIs) continue to affect most sexually active populations across the globe, especially the traditional high-risk groups for bacterial STIs such as young people, men who have sex with men (MSM) and individuals from black and minority ethnic populations. Bacterial STIs such as Gonorrhoea and Chlamydia remain common. In western settings, we have observed the re-emergence of high rates of syphilis and lymphogranuloma venereum, mostly in MSM. Urethral and vaginal discharge syndromes, genital ulcer disease are frequent clinical presentations. However, the development of highly sensitive molecular assays has revealed that asymptomatic infections are also common, particularly at extragenital sites, and probably drive transmission of STIs.

Nanomaterial continues to be a hot topic among regulatory agencies globally. The recent ban on TiO2 (E171) as a food additive in Europe has highlighted the need to have a comprehensive understanding of the global regulatory environment related to the presence of nanoparticles in food additives and excipients.