Cell-based therapies are a challenge to regulators because they involve withdrawing cells from a patient’s bone marrow, blood or adipose tissue, growing cells in vitro, and then administering in some form the expanded cells population back into the patient.
Address optimal configuration of a multi-column continuous chromatography (MCC) system, with insight into the impact antibody titer has on the number of chromatography columns required to optimize productivity of a MCC process.
Examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and understand practical, total solutions.
Review simplified continuous filtration, particularly for UF/DF, with a look into our exclusive license to patents in the field of single-pass tangential flow filtration (SPTFF), which enables continuous filtration without recirculation at several stages of a continuous bioprocess.
Addressing the concerns regarding limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments.