Target Product Profile
The Target Product Profile (TPP) is a strategic planning document used to guide vaccine development process from the earliest stages. It sets out clear parameters for the characteristics of the desired end product, and ensures that various departments are aligned on desired outcomes, product characteristics, and measures of success.
A well-crafted TPP presents optimistic, realistic, and minimal goals, and helps all stakeholders focus on the same aims. The TPP also guides the design, conduct, and analysis of clinical trials, as it allows the development team to focus on the desired characteristics of the vaccine and to ensure that the proposed clinical trials generate rigorous data, which may eventually support label claims.
The TPP helps create a product optimally suited for its intended use and market, and also contributes to the business case for product development. Emerging data on the product are benchmarked against the established TPP throughout the entire R&D process, and this information helps determine whether continued development is justified.
A good TTP displays the following:
- It has the ultimate goal in mind.
- It identifies the “optimal target” and a “minimal target.” For example, an optimal target for dosage schedule would be one vaccination that lasts a lifetime; a minimally acceptable target may be a series of vaccinations over a certain time period.
- As development proceeds, it should include status updates of completed or planned studies that support the targets.
- It enables the estimated targets to be refined, based on manufacturing, nonclinical, and clinical results.
- An early TPP may highlight some information that is estimated, or not available.
- Typically, the targets do not change unless the intended use of the product or standard of care changes, or in response to regulatory guidance.
- The final version of the TPP often serves as the precursor to the annotated product label.
The list here identifies some of the key categories and considerations that should feed into a TPP. Though not exhaustive, this list shows the breadth of information one should be ready to consider from even the earliest stages of vaccine discovery, development and manufacture.
- Indication for use (usage scenario- emergency/reactive or prophylactic/ preparedness, risk/benefit profile, etc. )
- Target population (age, gender, health profile, country of residence, vaccine recipient population size, data on previous pathogen/vaccine exposures etc.)
- Safety/reactogenicity (side effects etc.)
- Efficacy (effectiveness in preventing disease, speed of onset of immunity etc.)
- Dose regimen (single/multiple dose, time between doses, booster requirements etc.)
- Durability of protection (lifetime immunity, time-limited immunity etc.)
- Route of administration (injectable, non injectable, oral delivery etc.)
- Species coverage (monovalent, bivalent, trivalent etc.)
- Product stability and storage (shelf life, temperature requirements, preservatives, necessity/desirability/ability to stockpile etc.)
- Co-administration with other vaccines (interference with other vaccines etc.)
- Presentation (liquid/lyophilized, mono-dose/multi-dose, dosage volume etc.)
- Formulation (vial size, concentration, fill volume etc.)
- Production (number of doses required over what period of time, ability to scale up/out, high/low volume supply, affordability etc.)
- Registration and prequalification (Type of license- e.g. is it experimental?)
- Marketing attributes (Understanding the level of commercial interest, competitive advantage relative to competitor products, cost to produce versus anticipated sale price etc.)
- Post marketing surveillance (monitoring of safety, protection of the target population, indirect effects (herd immunity), potential serotype replacement following widespread use of the vaccine etc.)
For further information and guidance please see:
Lee & Burkeb (2010) Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles. Vaccine 28(16):2806-2809. PMCID: PMC3385993. NIHMSID: NIHMS384279
For further information and guidance please visit the Global HIV Vaccine Enterprise website.
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