NEW BIOTECHNOLOGY

whitePaper | March 30, 2023

The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered atrisk.

whitePaper | December 5, 2022

The adoption of LC-MS-based multi-attribute method (MAM) analysis for routine monitoring of biotherapeutic variation has progressed greatly over the last five years.

whitePaper | October 28, 2022

Adoptive cell therapy (ACT), a branch of immunotherapy, offers a promising treatment for chronic viral infections and malignant diseases such as cancer [1]. This innovative approach involves the autologous or allogenic transplant of immune cells into the patient’s body.

whitePaper | December 15, 2022

Regulatory teams at life science companies are finding that effective regulatory information management (RIM) has become critical to their operations.

whitePaper | September 17, 2021

The adoption of CAR T therapies in the UK NHS is a success story, especially seen in relation to the experience in many other countries. The UK NHS showed itself to be agile, and responsive to addressing the unique challenges these therapies present, which facilitated access to patients earlier than in many other countries. (including delivery centre selection, development of service specifications, collaboration with manufacturers throughout the preparation phase for adoption, establishment of national multidisciplinary CAR T team to ensure equity of access and prioritization of resources (where needed)).

whitePaper | February 11, 2022

The biomanufacturing revolution is here. Recent advancements in the field of synthetic biology have enabled significant cost reductions in foundational bioengineering unit operations such as DNA synthesis and sequencing.