Long-term follow-up studies of cell and gene therapies

whitePaper | January 7, 2022

While valuations for the life sciences sector in this past year have been mixed, the underlying performance and outlook for the sector is healthy

whitePaper | April 21, 2023

This technical note demonstrates the comprehensive characterization and confident identification of glucuronide metabolites from hepatocyte incubations of midazolam. An orthogonal fragmentation mechanism was applied to generate diagnostic fragmentions for confident identification of glucuronide metabolites

whitePaper | April 20, 2023

In the three decades that have passed since the approval of the first gene therapy in 1990, these revolutionary medicines have changed the lives of patients all over the world1.

whitePaper | November 19, 2022

Compiling a quality regulatory submission is a basic requirement for biopharmaceutical companies. Poor quality documents could lead to rejection of a regulatory application,

whitePaper | March 16, 2021

Cell and gene therapies have emerged as a new treatment paradigm, and with them has come the potential to alter the course of many rare diseases. In many cases, there is an opportunity to correct the underlying dysfunction with a one-time administration of a therapy and provide either a functional cure or a substantial improvement in health outcomes. In other cases, long term symptom relief will be the primary therapeutic objective. Some of these indications may require more than one dose to achieve continued symptom relief and scientists and companies are working on technologies that will enable the use of a repeat dose.

whitePaper | October 27, 2022

The cell and gene therapy (CGT) market is rapidly transitioning from ultra-niche cutting-edge science to approved and available therapies that can address previously intractable and often devastating diseases.