The Target Product Profile (TPP) is an indispensable strategic tool that provides a roadmap for biotechnology product development from preclinical to approval stages. Neglecting to develop a comprehensive TPP risks unfocused efforts, delays, and challenges that derail programs.
Key takeaways
- The TPP outlines desired product characteristics, intended use, patient population, manufacturing requirements and more and aligns stakeholders and informs regulatory strategies throughout development.
- Establishing a TPP early offers benefits like preventing delays and facilitating decision-making.
- The TPP should be regularly updated based on emerging data and assessments.
- Regulatory bodies provide guidance and encourage the use of TPPs for successful development. Having a well-crafted TPP assists in achieving constructive feedback from authorities.
Develop a robust Target Product Profile early. It guides decision-making and data incorporation through all stages. Read the full article to optimize TPP benefits throughout development.
