Biologic Product Risk Assessments

Monoclonal antibodies, Cell and Gene Therapy, RNA vaccines present amazing opportunities for amazing tailored therapeutics. But these therapeutics also bring with them the uncertainty inherent with new modalities of treatment. That uncertainty should be discharged to the extent possible and within the framework of the benefit-risk profile. Clinical assessments support:

• Critical Quality Attributes (CQA) – which attributes might require an enhanced control strategy for clinically-specific reasons?

• Clinical Impact of Common-Cause Variability in Manufacturing – Does the variability around an attribute impact the safety, efficacy or pharmacology of the product?

• Risk Management Plan (RMP) Review – Manufacturing changes (process, materials, site) and comparability protocols should all be reviewed for potential impact to the RMP and post-change pharmacovigilance monitoring.

• Clinically Relevant Specifications (CRS) – Identifying product attributes where acceptance criteria better represent a parameter that could be monitored versus one that clinical experience shows must be controlled within tight boundaries is critical to directing resources to the more appropriate point in the manufacturing process.

• Cleaning validation risk review – understanding proteinaceous residual carryover

  and evaluating the potential downstream impact on a subsequent product.