Get your assay in gear – removing analytical bottlenecks on the path to clinical readiness
Numerous cellular therapy candidates are quickly progressing to clinical stage manufacturing. Advances in automated processing have substantially reduced the development efforts needed for GMP-compliant manufacturing strategies. However, many therapeutics are delayed getting into the clinic due to lack of suitable analytical methods at an appropriate level of quality.
Flow cytometry is the predominant modality in cell therapy, employed to determine incoming product quality and composition, perform in-process-control (IPC), and ensure cellular identity and purity of final drug products.
Miltenyi Biotec (Bergisch Gladbach, Germany) is now focusing efforts toward standardization and automation of analytical characterization technologies that will allow streamlined IPC/quality control of cellular therapies.
What will you learn?
- How a lack of suitable analytical methods at an appropriate level of quality can often delay entry into the clinic for cellular therapeutics
- The applications and utility of flow cytometry in cell therapy manufacture for IPC and release testing of cellular identity and purity
- How the standardization and automation of flow cytometry can facilitate streamlined development and ultimately, a faster path to clinical approval
Who may this interest?
- Preclinical investigators working in translational settings of adoptive cell therapies
- Commercial and academic entities running clinical trials with adoptive cell therapies
- Flow cytometry core facility managers
Martha Elia Luevano Salinas, PhD
Global Product Manager, Group Leader Immunology Engineered Cells
Miltenyi Biotec B.V. & Co. KG
Martha Luevano is responsible for the clinical engineered cells portfolio including CAR-T and CAR-NK cells at Miltenyi Biotec. During the past 5 years, she has been working together with R&D and the Clinical Development team in order to advance the development of tools to enable CAR-T and CAR-NK cell immunotherapy.
Prior to joining Miltenyi Biotec, Martha did her postdoctoral research in stem cells (Miltenyi Biotec-Marie Curie fellowship) and her PhD at Anthony Nolan (University College London, UK) finding solutions to expand NK cells for therapeutic purposes. Her combined experience in molecular and cellular research has made her the recipient of international grants and fellowships.
Jakob Bonse, Dr
Global Product Manager, Flow Cytometry Instrumentation
Miltenyi Biotec B.V. & Co. KG
Jakob Bonse completed his PhD at the Westfälische Wilhelms University of Münster (Germany), where he worked in the field of Molecular Nephrology, Metabolism and End-Stage Renal Diseases. Jakob gained expert knowledge in the field of Hippo Signaling and Cell Transduction. He joined the Marketing team of Miltenyi Biotec in June 2019 as a product manager, where he is responsible for flow cytometry instruments and is coordinating dedicated marketing activities.