Is the QbD Toolbox Ready for Cell and Gene Therapies?Integrating Patient Outcomes into Manufacturing Cell and Gene Therapy Bioproducts

摘要

In their lifecycle development anc manufacturing models, biotechnology products and the biopharmaceutical industry have been founded on principles originatin from the pharmaceutical small-molecule industry. Such principles define clinical programs that establish risk benefits of a dosage and its delivery system on healthy individuals and patients. A company then develops a process to manufacture that product consistently over several years. Product quality attributes set through manufacturing controls are expected to ensure patient outcomes in terms of safety and efficacy and deliver the clinical performance designed, irrespective of patient-to-patient differences and variability in manufacturing operations over a product's lifecycle.