Tag: <span>virus safety testing</span>

The heterogenous group of advanced therapy medicinal products (ATMPs) are biologics with frequently limited viral safety profiles. As compared to well-established biologics such as monoclonal antibody products, the risk of virus contamination is significantly higher for some ATMPs. The standard approaches and tools used to mitigate the viral risk have limitations, leaving open the chances of missing virus contamination in an ATMP manufacturing process in both upstream and downstream. Next-generation sequencing (NGS) technology can overcome the residual risk by having the potential to detect any kind of virus contamination based on its inherent capability to detect any kind of nucleic acid in a sample. It perfectly combines the benefits and compensates for the downsides of the existing testing tools. It will replace a bunch of different established testing methods at improved turnaround times and, in the end, reduced overall costs. The combination of these characteristics is making NGS-based virus testing an in-demand and preferred approach to mitigating the virus contamination risk across all kinds of biologics mid- and long-term.

Bioinformatics Biologics Production Cell & Gene Therapy Regulatory Risk Analysis and Management Viral Reference Materials Viral Vectors

Today, many if not all of the major pharmaceutical companies have specific budgets for large research and development pipelines for new biologics including vaccines, monoclonal antibodies, recombinant proteins and even gene therapy projects. In addition, small innovative companies are continually presenting us with novel treatment opportunities which hold great promise for the future. The reason for such huge optimism in the field of biologics is that there are now a number of “blockbuster” drugs for which the safety profile has been very successfully managed. This success has been achieved following a considerable amount of time and financial investment by both the innovators and the regulators…

Biologics Production Risk Analysis and Management