Vision
Early-stage drug product and biomaterials programs are often undermined by empirically sequenced formulation decisions made without first establishing the variables that govern critical response outcomes. Experimental effort is frequently applied before resolving which formulation variables and material attributes define critical quality attributes (CQAs) and critical material attributes (CMAs), and how these propagate into downstream performance and CMC risk. As a result, trial-and-error exploration of design space obscures structure–property relationships, inflates experimental cost, and yields systems that are difficult to rationalize, reproduce, or translate.
Volperion was established to impose constraint, structure, and mechanistic clarity on drug product and biomaterials design—supporting QbD-aligned, risk-focused development before resources are committed to non-limiting variables.
Our Approach
Volperion supports early-stage drug product and biomaterials development through mechanistically informed analysis and decision support across formulation and materials design.
Our work focuses on:
identifying formulation variables and material attributes that govern critical response outcomes
constraining experimental design using statistically disciplined approaches
integrating mechanistic and modeling insight to guide formulation decisions
Engagements are scoped to complement internal R&D and external CRO activities, with emphasis on early-stage risk reduction and experimental efficiency.