Designing Quality into the Product: Early Developability Assessment in Biopharmaceutical Development

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The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development critical to determining the success of a new drug candidate are: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical stages can often extend development timelines or require additional process optimization, therefore costing the developer more time and money. It is desirable to avoid such costly issues by selecting the candidate with the highest probability of success early in its development by asking the right questions.