Vector Production Process

Product manufacturing follows a linear flow of unit operations and utilizes disposable, closed bioprocessing circuits as much as possible.  A single product is manufactured within the CMF at any given time.

The rAAV vector production process is flexible and employs either plasmid DNA transfection or uses a qualified, stable rAAV producer cell line depending on product scale. 

• Vector purification employs microfluidization for cell disruption, followed by depth filtration for feed clarification.
• Tangential flow filtration is utilized to reduce lysate volume and for buffer diafiltration for downstream FPLC application.
• Iodixanol gradient purification serves as an orthogonal purification step to remove the majority of empty particles.
• Rigorous QC testing is performed in-process, at purified bulk and for final product release.
• Production assay results are reviewed by the QAU to ensure product meets pre-defined acceptance criteria.