Structure and identity
Clarify which identity or structural question matters for the current development decision and what reference context is available.
Biologics Characterization
Build the characterization plan around product and development risk.
Use the product context and the decision to be supported to organize a focused discussion across structure, physicochemical attributes, product variants, functional questions, and process-related impurities.
Questions to scope
Organize the discussion by the risk being investigated.
Physicochemical attributes and variants
Identify the product attributes or variant questions that need comparison, trend assessment, or further investigation.
Function and impurity context
Define the functional question and the process or product-related impurity context without assuming one universal method set.
Before a technical discussion
Prepare the minimum context needed for responsible scoping.
- Modality and construct or product format
- Development stage and decision to be supported
- Available sample types, quantities, and reference materials
- Known risks, prior observations, or comparison groups
- Expected use of the results and required review points