Advisor
Advisor

Subscribe

Please type this word to confirm you're human:

Identification of Teriparatide by Sodium dodecyl sulfate polyacrylamide (SDS-PAGE)

Kashish Chaudhary2, Priyanka Chaudhary1, Anu Prakash1, Anubhuti Goyal1, Muthusamy Kalaivani1*, Meenakshi Dahiya1, Vivekanandan Kalaiselvan1

1 Biologics Division, Indian Pharmacopoeia Commission, Sector-23, Raj Nagar, Ghaziabad (U.P), India.

2 Amity Institute of Biotechnology, Amity University, Sector-125, Gautam Budh Nagar (U.P), India.

Corresponding Author

Dr. Muthusamy Kalaivani
Principal Scientific Officer,
Indian Pharmacopoeia Commission,
Ministry of Health and Family Welfare, Govt. of India,
Sector-23, Raj Nagar, Ghaziabad-201002, India.

Running Title

Identification of Teriparatide by SDS-PAGE

Abstract

Background: SDS-PAGE is a widely used technique for identifying and characterizing proteins based on their size and charge. Teriparatide, a synthetic form of the N-terminal fragment of human parathyroid hormone (PTH), can be identified through SDS-PAGE by its distinct molecular weight (~4.2 kDa) and migration pattern. This method enables the verification of its purity and confirmation of its protein structure during quality control processes.

Aim: The aim of this study is to identify teriparatide through SDS-PAGE by evaluating its molecular weight and migration characteristics in comparison to a reference standard. This technique allows for the accurate determination of its purity and helps confirm the integrity of the recombinant protein. Additionally, it provides a reliable method for distinguishing teriparatide from other protein contaminants. Ultimately, this approach supports quality control and ensures the consistency of the therapeutic agent.

Material & Method: In this study, we evaluated teriparatide via SDS-PAGE, checking its molecular weight for similarity and conducting qualitative analysis in comparison to a reference standard.

Results: Teriparatide's molecular weight and purity were evaluated using SDS-PAGE. Teriparatide (~4.2 kDa) is represented by a single band on polyacrylamide gel that was stained with silver nitrate. No additional bands were observed, suggesting minimal degradation or the presence of impurities. These results confirm the identity and purity of the teriparatide sample.

Conclusion: SDS-PAGE successfully identified teriparatide by revealing its distinct molecular weight and migration pattern. The technique confirmed the protein's purity, ensuring that it met the required standards for therapeutic use. The results also validated the structural integrity of the recombinant protein, distinguishing it from potential contaminants. SDS-PAGE proved to be an effective and reliable method for quality control in the production of teriparatide. Overall, this approach guarantees the consistency and safety of the therapeutic agent for clinical application.

Keywords

Teriparatide, SDS-PAGE, human parathyroid hormone, electrophoresis

References

  1. Falaschi, P., Marques, A., & Giordano, S. (2021). Osteoporosis and fragility in elderly patients. Orthogeriatrics: The management of older patients with fragility fractures, 35-52.
  2. Kothiyal, P., & Sharma, M. (2017). Post menopausal quality of life and associated factors—a review. American Journal of Pharm Research, 3(9), 7175-7183.
  3. Qaseem, A., Hicks, L. A., Etxeandia-Ikobaltzeta, I., Shamliyan, T., Cooney, T. G., Clinical Guidelines Committee of the American College of Physicians, & Tufte, J. E. (2023). Pharmacologic treatment of primary osteoporosis or low bone mass to prevent fractures in adults: a living clinical guideline from the American College of Physicians. Annals of internal medicine, 176(2), 224-238.
  4. Russell, G. (2024). Introduction: bone metabolism and its regulation. In Bone Markers (pp. 1-26). CRC Press.
  5. Jha, S. S. (2023). Biologics: Teriparatide and Newer Anabolics. Indian Journal of Orthopaedics, 57(Suppl 1), 135-146.
  6. Chilakapati, R., Mannully, C. T., & Pulicherla, K. K. (2019). Prospects of parathyroid hormone in therapeutic intervention. International Journal of Peptide Research and Therapeutics, 25, 961-977.
  7. Guerreiro, P. M., Renfro, J. L., Power, D. M., & Canario, A. V. (2007). The parathyroid hormone family of peptides: structure, tissue distribution, regulation, and potential functional roles in calcium and phosphate balance in fish. American Journal of Physiology-Regulatory, Integrative and Comparative Physiology, 292(2), R679-R696.
  8. Osagie-Clouard, L., Sanghani, A., Coathup, M., Briggs, T., Bostrom, M., & Blunn, G. (2017). Parathyroid hormone 1-34 and skeletal anabolic action: The use of parathyroid hormone in bone formation. Bone & joint research, 6(1), 14-21.
  9. Raterman, H. G., Bultink, I. E., & Lems, W. F. (2019). Current treatments and new developments in the management of glucocorticoid-induced osteoporosis. Drugs, 79(10), 1065-1087.
  10. Dore, R. K. (2013). Long-term safety, efficacy, and patient acceptability of teriparatide in the management of glucocorticoid-induced osteoporosis. Patient preference and adherence, 435-446.
  11. Watanabe, A., Yoneyama, S., Nakajima, M., Sato, N., Takao-Kawabata, R., Isogai, Y., Sakurai-Tanikawa, A., et al. (2012). Osteosarcoma in Sprague-Dawley rats after long-term treatment with teriparatide (human parathyroid hormone (1-34)). The Journal of toxicological sciences, 37(3), 617-629.
  12. Tashjian Jr, A. H., & Gagel, R. F. (2006). Teriparatide [human PTH (1‐34)]: 2.5 years of experience on the use and safety of the drug for the treatment of osteoporosis. Journal of bone and mineral research, 21(3), 354-365.
  13. Cosman, F., Nieves, J. W., & Dempster, D. W. (2017). Treatment sequence matters: anabolic and antiresorptive therapy for osteoporosis. Journal of bone and mineral research, 32(2), 198-202.
  14. Chandran, M., Akesson, K. E., Javaid, M. K., Harvey, N., Blank, R. D., Brandi, M. L., & Silverman, S. (2024). Impact of osteoporosis and osteoporosis medications on fracture healing: a narrative review. Osteoporosis International, 35(8), 1337-1358.
  15. Yoon, B. H., & Kim, K. C. (2020). Does teriparatide improve fracture union?: a systematic review. Journal of bone metabolism, 27(3), 167.
  16. Kovåcs, P., SchÀfer, T., Håda, V., Hevér, H., Klingelhöfer, S., Nebel, M., & Urbånyi, Z. (2020). Comparative physicochemical and biological characterisation of the similar biological medicinal product teriparatide and its reference medicinal product. BioDrugs, 34, 65-75.
  17. Chunxiao, W., Jingjing, L., Yire, X., Min, D., Zhaohui, W., Gaofu, Q., Xiangchun, S., Xuejun, W., Jie, W., Taiming, L. (2007). Study on preparation and activity of a novel recombinant human parathyroid hormone(1-34) analog with N-terminal Pro-Pro extension. Regul Pept, 141(1-3), 35-43.
  18. FernĂĄndez-Carneado, J., VallĂšs-Miret, M., Arrastia-Casado, S., AlmazĂĄn-Moga, A., Macias, M.J., Martin-Malpartida, P., Vilaseca, M., DĂ­az-Lobo, M., Vazquez, M., Sanahuja, R.M., et al. (2024). First Generic Teriparatide: Structural and Biological Sameness to Its Reference Medicinal Product. Pharmaceutics, 16(4), 537.
  19. Ughade, S., Rana, S., Nadeem, M., Kumthekar, R., Mahajani, S., & Bhambure, R. (2024). Mechanistic Modeling of Size Exclusion Chromatography-Assisted In Vitro Refolding of the Recombinant Biosimilar Teriparatide (PTH-34). ACS Omega, 9(3), 3204-3216.
  20. Couchman, L., Taylor, D. R., Krastins, B., Lopez, M. F., & Moniz, C. F. (2014). LC-MS candidate reference methods for the harmonisation of parathyroid hormone (PTH) measurement: a review of recent developments and future considerations. Clinical Chemistry and Laboratory Medicine (CCLM), 52(9), 1251-1263.
  21. Sharma, N., Kukreja, D., Giri, T., Kumar, S., & Shah, R. P. (2022). Synthetic pharmaceutical peptides characterization by chromatography principles and method development. Journal of Separation Science, 45(13), 2200-2216.
  22. Wagner, W. J., Moyle, A. B., Wagner, N. D., Rempel, D. L., & Gross, M. L. (2024). Evaluating chemical footprinting-induced perturbation of protein higher order structure. Analytical chemistry, 96(23), 9693-9703.
  23. Patel, A., & Patel, R. (2023). Analytical method development for biologics: Overcoming stability, purity, and quantification challenges. Journal of Applied Optics, 44(1S), 1-29.
  24. Nowakowski, A. B., Wobig, W. J., & Petering, D. H. (2014). Native SDS-PAGE: high resolution electrophoretic separation of proteins with retention of native properties including bound metal ions. Metallomics, 6(5), 1068-78.
  25. Haider, S. R. (2012). Enhanced gel electrophoresis (GE) and inductively coupled plasma-mass spectrometry (ICP-MS) based methods for the identification and separation of proteins and pepides (Doctoral dissertation, Loughborough University).
  26. Mitsudome, T., Moribe, M., Obayashi, Y., Uchiyama, A., & Aono, M. (2020). Influence of low-molecular-weight aggregates on aggregate growth kinetics and physical properties of solid-state proteins during storage. Eur J Pharm Biopharm, 146, 10-18.
  27. Narayanan, H., Dingfelder, F., Morales, I. C., Patel, B., Heding, K. E., Bjelke, J. R., Egebjerg, T., Butté, A., Sokolov, M., Lorenzen, N., & Arosio, P. (2021). Molecular Pharmaceutics, 18, 3843-3853.

Publication Details

  • Article ID: O0701031 RA Preprint
  • Received: 10/07/2025
  • Accepted: 30/08/2025
  • Published: 30/08/2025
  • DOI: Pending

Citations

Chaudhary, K., Chaudhary, P., Prakash, A., Goyal, A., Kalaivani, M., Dahiya, M., & Kalaiselvan, V. (2025). Identification of Teriparatide by Sodium dodecyl sulfate polyacrylamide (SDS-PAGE). Journal of Allbiosolution, 7(1), 311–316.

Kashish Chaudhary et al. Identification of Teriparatide by Sodium dodecyl sulfate polyacrylamide (SDS-PAGE). Journal of Allbiosolution, 2025, 7(1): 311-316.

K. Chaudhary et al. Identification of Teriparatide by Sodium dodecyl sulfate polyacrylamide (SDS-PAGE). Allbiosolution, 2025, 7(1): 311-316.