Are Nitrosamines a Concern for Biologic Manufacturers?

whitePaper | November 11, 2022

Biocontamination refers to biological contamination of products by bacteria and/or fungi, as well as the toxic by-products of these microorganisms, such as endotoxin and mycotoxins from Gram-negative bacteria and fungi, respectively.

whitePaper | March 22, 2022

The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic.

whitePaper | January 24, 2022

Since early 2020, coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome.

whitePaper | February 25, 2022

Digitalization and automation promise a better way to streamline the transfer of cell and gene therapies from drug discovery – to commercial production.

whitePaper | July 12, 2023

The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered atrisk. This article provides an assessment of nitrosamine contamination specifically in biologics and contrasts the potential risks between these product types.

whitePaper | April 24, 2022

The Global Forum on Biotechnology, established in 2010, is one of 15 Global Fora created by OECD Committees. Global Fora are not official OECD bodiesbut are best described as broad.