Author Archives: Sofia T. Santos

Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle

Biopharmaceutical manufacturing processes that were developed before the implementation of quality by design (QbD) typically use control strategies that are not founded on a formal understanding of criticality. Thus, manufacturers of “legacy” products lack the understanding of critical process parameters (CPPs) and critical quality attributes (CQAs). Introducing such elements to a legacy biologic drug product filing aligns fully with expectations described in the ICH Q12 guideline (e.g., increased process understanding and better risk mitigation strategies) (1). Here we discuss how…

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

In their lifecycle development and manufacturing models, biotechnology products and the biopharmaceutical industry have been founded on principles originating 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…