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A Target Product Profile (TPP) is a summary of the proposed finished drug product quality characteristics established during development. A TPP is a useful guide, bringing focus to desired product quality: purity, safety, and efficacy. The TPP is dynamic, to be further defined as new knowledge is gained over the product lifecycle. The TPPs result from enhanced product knowledge and therefore, aid in discussions with drug discovery and product development teams, clinical groups, manufacturing organizations, and regulatory agencies. This collaboration allows for product and process improvements and ease of risk-based decisions. Lack of focus on the TPPs throughout the drug development process can result in a loss of historical data and an increase in time to market.
As a new drug progresses through clinical development, the focused studies yield further insight into TPPs and enhancement of potential Critical Quality Attributes (CQAs). “A CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality” (ICH Q8). As an example, typical CQAs for lyophilized dosage forms are aspects affecting purity, strength, and stability. Once identified, CQAs can be prioritized as essential or desirable through risk-based analysis to form a hierarchy of relative importance. Further development focuses on essential CQAs and manufacturability considerations, which are paramount when a product progresses through clinical to commercial manufacturing.
From drug discovery, prior to and during development, TPPs are identified based on desirable finished product characteristics. Indication, patient population, and route of administration are examples of fundamental considerations, which may vary for each product.
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