Biologic Product Risk Assessments

Monoclonal antibodies, Cell and Gene Therapy, RNA vaccines present amazing opportunities for individualized, tailored therapeutics. But they 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 require an enhanced control strategy for clinical reasons?

  • Clinical Impact of Common Cause Variability in Manufacturing – Does 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 attributes where acceptance criteria better represent a parameter that should be monitored versus one that clinical experience shows must be managed within tight boundaries is critical to directing resources to the appropriate point in the manufacturing process.

  • Cleaning validation risk review – understanding carryover proteinaceous residuals and discharging the potential downstream impact using the product’s available data.

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