• Assays which take advantage of specific chemical properties of nucleic acids
(aptamers) including DNA “combing” (plastic adhesion at neutral pH) or facile
modification of nucleic acids with attachment or reporter chemical groups and
modified bases or exotic nucleotides to enhance binding [8]. Bruno utilized the
ability of DNA (aptamers) to adhere to polystyrene to concentrate and isolate or
purify aptamer-bound pathogenic bacteria on the inside of plastic cuvettes as the
basis for a novel sensitive assay format called plastic-adherent sandwich assay or
“PASA” [33, 34].
• Storage and transport: Aptamers are highly stable at a wide range of temperatures
(15–90
C), a feature which enables higher shelf life and cost-effective storing
conditions. Bruno demonstrated that his group’s C-telopeptide aptamer beacon
assay was unimpaired in its low ng/ml detection of this bone loss peptide even
after 5.5 years of storage at ambient temperature in a lyophilized state [35]. While
many dried antibody-based lateral flow test strips also have long shelf lives, few
are validated beyond more than a few years in sealed or vacuum-packed
envelopes.
4 Conclusions
Aptamers are a unique class of nucleic acids able to recognize their targets with high
affinity and high specificity, similar to the popular antibodies. To date, aptamers
have proven to be a versatile tool for healthcare and biomedical research, particularly
in the diagnostics arena. In order to unleash their full potential in diagnosis and
treatment of various diseases, it is important to develop, design, and understand the
indispensable significance of the target product profile (TPP). The presence of this
strategic document will be useful for the researchers and biological experts to review
and assess the product development process, desired features, likely course of
research and development, and all other scientific and technical information required
to reach the desired product outcome. In addition, TPP is a valuable tool to reduce
the bench-to-bedside translation times of aptamer molecules, thus making the
process faster, more cost-effective, and accessible, particularly in resource-limited
settings.
References
1. Ellington AD, Szostak JW (1990) © 1990 Nature Publishing Group. Lett Nat 346:818–822.
https://doi.org/10.1016/0021-9797(80)90501-9
2. Tuerk C, Gold L (1990) Systematic evolution of ligands by exponential enrichment: chemiSELEX. Science 249:505–510. https://doi.org/10.1038/346818a0
3. Nimjee SM, Rusconi CP, Sullenger BA (2005) Aptamers: an emerging class of therapeutics.
Annu Rev Med 56(1):555–583. https://doi.org/10.1146/annurev.med.56.062904.144915
Defining Target Product Profiles (TPPs) for Aptamer-Based Diagnostics
207
(aptamers) including DNA “combing” (plastic adhesion at neutral pH) or facile
modification of nucleic acids with attachment or reporter chemical groups and
modified bases or exotic nucleotides to enhance binding [8]. Bruno utilized the
ability of DNA (aptamers) to adhere to polystyrene to concentrate and isolate or
purify aptamer-bound pathogenic bacteria on the inside of plastic cuvettes as the
basis for a novel sensitive assay format called plastic-adherent sandwich assay or
“PASA” [33, 34].
• Storage and transport: Aptamers are highly stable at a wide range of temperatures
(15–90
C), a feature which enables higher shelf life and cost-effective storing
conditions. Bruno demonstrated that his group’s C-telopeptide aptamer beacon
assay was unimpaired in its low ng/ml detection of this bone loss peptide even
after 5.5 years of storage at ambient temperature in a lyophilized state [35]. While
many dried antibody-based lateral flow test strips also have long shelf lives, few
are validated beyond more than a few years in sealed or vacuum-packed
envelopes.
4 Conclusions
Aptamers are a unique class of nucleic acids able to recognize their targets with high
affinity and high specificity, similar to the popular antibodies. To date, aptamers
have proven to be a versatile tool for healthcare and biomedical research, particularly
in the diagnostics arena. In order to unleash their full potential in diagnosis and
treatment of various diseases, it is important to develop, design, and understand the
indispensable significance of the target product profile (TPP). The presence of this
strategic document will be useful for the researchers and biological experts to review
and assess the product development process, desired features, likely course of
research and development, and all other scientific and technical information required
to reach the desired product outcome. In addition, TPP is a valuable tool to reduce
the bench-to-bedside translation times of aptamer molecules, thus making the
process faster, more cost-effective, and accessible, particularly in resource-limited
settings.
References
1. Ellington AD, Szostak JW (1990) © 1990 Nature Publishing Group. Lett Nat 346:818–822.
https://doi.org/10.1016/0021-9797(80)90501-9
2. Tuerk C, Gold L (1990) Systematic evolution of ligands by exponential enrichment: chemiSELEX. Science 249:505–510. https://doi.org/10.1038/346818a0
3. Nimjee SM, Rusconi CP, Sullenger BA (2005) Aptamers: an emerging class of therapeutics.
Annu Rev Med 56(1):555–583. https://doi.org/10.1146/annurev.med.56.062904.144915
Defining Target Product Profiles (TPPs) for Aptamer-Based Diagnostics
207