Considerations For Development Of A Platform Lentivirus Harvest Clarification Process For Cell And Gene Therapy

By John Taylor, MilliporeSigma and Luan Truong, WuXi Advanced Therapies

New therapies and cutting-edge technologies have enabled the production of next-generation treatments that improve patient care, simplify administration and increase the availability of life changing medicines. One of the new technologies emerging in the biotech manufacturing market is the use of viral vectors for cell and gene therapy. One commonly used viral vector in this space is lentivirus, due to its robustness to package and deliver target DNA. Clarification is an important step in the manufacturing process as it impacts efficiency and subsequent downstream steps. Particle size, surface charge, as well as assay variability are among what causes difficulty when clarifying lentivirus harvest and significant losses in post-clarification virus titer yield and potentially low capacity can be observed. This work explores a variety of lentivirus harvest clarification options and items for consideration during manufacturing platform development of viral therapy production using suspension cell lines.