Case Study – How a QbD Approach Assisted with the Commercialisation of a Stem Cell Therapeutic Drug, Accelerating the Product to Market
June 24, 2026
BioProcess Theatre
Type: BioProcess Session
This presentation describes the progress of a stem-cell therapeutic & commercial development from phase 3 and lessons learned. Specific challenges existing within the stem cell therapeutics and regenerative medicine arena will be discussed. The application of QbD & DoE to the process and the assays used to address CPPs and CQAs aspects of the product will be discussed as well as how these approaches aided successful PAI and BLA approval.
Speakers
)
)
){kind=logo}
){kind=logo}
)
)
){kind=logo}
){kind=logo}