Adv Biochem Eng Biotechnol (2020) 174: 195– 210
DOI: 10.1007/10_2019_104
© Springer Nature Switzerland AG 2019
Published online: 23 July 2019
Defining Target Product Profiles (TPPs)
for Aptamer-Based Diagnostics
Harleen Kaur, Bandhan Chaterjee, John G. Bruno,
and Tarun Kumar Sharma
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
2 Designing of TPP, Benefits, and Its Key Features . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . .. . . . . . . 198
2.1 Benefits of Designing a TPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
2.2 Features of a TPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
3 Applications of Defining TPPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
3.1 TPP for Tuberculosis (TB) Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
3.2 TPP for Point-Of-Care (POC) Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
3.3 Diagnostic Detection of Bacterial Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
3.4 Other Aptamer-Specific TPPs and Diagnostic Applications . . . . . . . . . . . . . . . . . . . . . . . . . 206
4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Abstract Defining target product profiles (TPPs) for aptamer-based diagnostics is
crucial to the success or failure of aptamer businesses or products. A well-conceived
TPP will place the aptamer in an assay for a target against which antibodies are
ill-suited or have difficulty detecting the analyte, such as some highly related proteins or poorly immunogenic small molecule haptens. Strong TPPs can also take
advantage of the unique nucleic acid nature of aptamers, to produce assays with
Harleen Kaur and Bandhan Chaterjee contributed equally to this work.
H. Kaur
Aurobindo Biologics, Hyderabad, India
B. Chaterjee and T. K. Sharma (*)
Centre for Biodesign and Diagnostics, Translational Health Science and Technology Institute
(THSTI), Faridabad, Haryana, India
e-mail: tarun@thsti.res.in
J. G. Bruno
Nanohmics Inc., Austin, TX, USA
DOI: 10.1007/10_2019_104
© Springer Nature Switzerland AG 2019
Published online: 23 July 2019
Defining Target Product Profiles (TPPs)
for Aptamer-Based Diagnostics
Harleen Kaur, Bandhan Chaterjee, John G. Bruno,
and Tarun Kumar Sharma
Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
2 Designing of TPP, Benefits, and Its Key Features . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . .. . . . . . . 198
2.1 Benefits of Designing a TPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
2.2 Features of a TPP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199
3 Applications of Defining TPPs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
3.1 TPP for Tuberculosis (TB) Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
3.2 TPP for Point-Of-Care (POC) Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203
3.3 Diagnostic Detection of Bacterial Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
3.4 Other Aptamer-Specific TPPs and Diagnostic Applications . . . . . . . . . . . . . . . . . . . . . . . . . 206
4 Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Abstract Defining target product profiles (TPPs) for aptamer-based diagnostics is
crucial to the success or failure of aptamer businesses or products. A well-conceived
TPP will place the aptamer in an assay for a target against which antibodies are
ill-suited or have difficulty detecting the analyte, such as some highly related proteins or poorly immunogenic small molecule haptens. Strong TPPs can also take
advantage of the unique nucleic acid nature of aptamers, to produce assays with
Harleen Kaur and Bandhan Chaterjee contributed equally to this work.
H. Kaur
Aurobindo Biologics, Hyderabad, India
B. Chaterjee and T. K. Sharma (*)
Centre for Biodesign and Diagnostics, Translational Health Science and Technology Institute
(THSTI), Faridabad, Haryana, India
e-mail: tarun@thsti.res.in
J. G. Bruno
Nanohmics Inc., Austin, TX, USA