A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design

Application of QbD Principles to Late-Stage Formulation Development for Biological Liquid Products

“…QbD elements can be embedded into existing programs as discussed by Martin-Moe et al (2011) While an important step in applying QbD is the development of smallscale models it is imperative that these are representative of full-scale operations. Process understanding using small-scale models needs to be built into timelines, at least for the first few molecules in a class (e.g., IgG1 mAbs).…”

An Overview of Quality by Design for Drug Product

“…Edge of failure and range finding studies are very limited due to material availability and cost. Using a QbD approach, small scale, worst case, and surrogate models allow for studying the impact of the process on product quality and interactive effects (Martin-Moe et al 2011). In the following chapters on unit operations, small scale and worst case models are heavily leveraged in order to define design space, for example in chapters QbD impact summary-Validated models are used to study ranges for all unit operations and deepen process knowledge.…”

CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

“…According to ICH Q9, risk management is comprised of risk assessment (identification, analysis, and evaluation), risk control (reduction and acceptance), and risk review (continuous evaluation and adjustment) (9). Some applications which contain elements of quality by design have included the risk management tools delineated in the ICH Q9 (10). In addition, risk-based strategies are increasingly being applied to the development of products containing nanotechnology (11,12).…”