that will be used as a tool to guide the entire process of the product development,
known as target product profile (TPP). A TPP is nothing but an elaborate and welldeliberated plan, spanning all the relevant sections from product development to
marketing [10]. A well-designed TPP ensures that the R&D is well directed to
develop products that satisfy the context and need of the end users properly.
Organizations like the Foundation for Innovative New Diagnostics (FIND) further
simplify the process by convening the various stakeholders like researchers, clinicians, and end users to gather their views on the product, to develop a better TPP.
While most target product profiles (TPP) for aptamers are similar to almost any
other business or product development plan to sell a “widget” which targets a
specific need, aptamers present some unique opportunities and challenges when
compared to their antibody or immunodiagnostic competitors which have been quite
commercially successful. Thus, planning of specific aptamer development for particular targets (TPPs) is extremely important to the eventual success or failure of
aptamer-based diagnostics. We begin with a general discussion of TPPs with
emphasis on aptamer diagnostic products below.
2 Designing of TPP, Benefits, and Its Key Features
A TPP document can be used as a strategy planning tool in the development of
aptamers for diagnostic assays and also other biomolecules. The development of the
TPP and its execution is a joint effort between various stakeholders, such as the team
of scientists (or technical team), regulatory authorities, investors, supply chain, and
senior management, and can often be used as a reference document for post
development discussions.
2.1 Benefits of Designing a TPP
Defining TPP as per its intended use from the beginning of the execution of a project
increases the chance of success many folds, as it allows the researchers to design
their aptamer as per the requirement of regulatory bodies. The other main advantage
of a TPP is that it can serve as an excellent tool for designing, communicating, and
tracking the progress and modifications during the aptamer-based diagnostics development. In addition, as it is not limited to aptamer diagnostics, TPPs could also be
employed for drug discovery research as well as drug development and have already
been utilized for in vitro diagnostics (IVD)-based products for several companies
[11]. Also, this kind of exercise could gather a lot of information and feedback from
a wide variety of stakeholders from different disciplines, background, and geographies which helps to make well-informed decisions and provide value to the end
users, investors, and sponsors.
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known as target product profile (TPP). A TPP is nothing but an elaborate and welldeliberated plan, spanning all the relevant sections from product development to
marketing [10]. A well-designed TPP ensures that the R&D is well directed to
develop products that satisfy the context and need of the end users properly.
Organizations like the Foundation for Innovative New Diagnostics (FIND) further
simplify the process by convening the various stakeholders like researchers, clinicians, and end users to gather their views on the product, to develop a better TPP.
While most target product profiles (TPP) for aptamers are similar to almost any
other business or product development plan to sell a “widget” which targets a
specific need, aptamers present some unique opportunities and challenges when
compared to their antibody or immunodiagnostic competitors which have been quite
commercially successful. Thus, planning of specific aptamer development for particular targets (TPPs) is extremely important to the eventual success or failure of
aptamer-based diagnostics. We begin with a general discussion of TPPs with
emphasis on aptamer diagnostic products below.
2 Designing of TPP, Benefits, and Its Key Features
A TPP document can be used as a strategy planning tool in the development of
aptamers for diagnostic assays and also other biomolecules. The development of the
TPP and its execution is a joint effort between various stakeholders, such as the team
of scientists (or technical team), regulatory authorities, investors, supply chain, and
senior management, and can often be used as a reference document for post
development discussions.
2.1 Benefits of Designing a TPP
Defining TPP as per its intended use from the beginning of the execution of a project
increases the chance of success many folds, as it allows the researchers to design
their aptamer as per the requirement of regulatory bodies. The other main advantage
of a TPP is that it can serve as an excellent tool for designing, communicating, and
tracking the progress and modifications during the aptamer-based diagnostics development. In addition, as it is not limited to aptamer diagnostics, TPPs could also be
employed for drug discovery research as well as drug development and have already
been utilized for in vitro diagnostics (IVD)-based products for several companies
[11]. Also, this kind of exercise could gather a lot of information and feedback from
a wide variety of stakeholders from different disciplines, background, and geographies which helps to make well-informed decisions and provide value to the end
users, investors, and sponsors.
198
H. Kaur et al.