Early Implementation of QbD in Biopharmaceutical Development: A Practical Example

Figure 4

Implementation of developability methodologies in different stages of discovery and development and its relationship with number of lead candidates and available data. As the number of potential candidates converge into a smaller number, the amount of available experimental data increases. In silico computational methods can, by comparison, yield a lot of information at an early stage. As the product candidates progress in development, the introduction of in vitro analytics becomes feasible and an important element to help the decision-making process.