Скачать с ютуб CGT Summit 2024 - Kostadinka Lilova, Autolus Therapeutics, UK в хорошем качестве

CGT Summit 2024 - Kostadinka Lilova, Autolus Therapeutics, UK

Miltenyi Cell and Gene Therapy Summit 2024 - Obe-cel manufacturing process development by Kostadinka Lilova, Autolus Therapeutics, UK. The FELIX study was the latest stage of the development of obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory (r/r) Adult B-Cell Acute Lymphoblastic Leukemia (ALL) at the UK-based CAR T cell therapy company, Autolus Therapeutics. The approval of its Biologics License Application (BLA) by the U.S. Food and Drug Administration (FDA) is expected by November 2024, and Autolus seeks for its first autologous CAR T product to become commercial. The journey for obe-cel started at the University College London Hospitals and UCL, in collaboration with Autolus under the oversight of Claire Roddie (Trial Investigator) and Martin Pule (Founder and CSO of Autolus). The obe-cel manufacturing process evolved from highly manual manipulations and expansion in a rocking motion bioreactor to the current semi-automated CliniMACS Prodigy®-based cell processing. While the process development had a challenging journey due to the high impact of the disease burden on the quality of the patient starting material, Autolus was able to conclude the trial with a robust process, which serves as a foundation for its future platform processes. Moreover, Autolus established a short vein-to-certification (V2C) time (median of 21 days), which is being improved. Obe-cel shows a very good safety and efficacy profile and has the potential to be a great option for patients with B-ALL. Talk presented at the Miltenyi Cell and Gene Therapy Summit 2024. Click through to hear more information from your colleagues' experiences and challenges, find relevant upcoming events, or sign up for our newsletter to connect with your community. - Empower cells, empower lives