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Showing posts with label SDS-PAGE. Show all posts
Showing posts with label SDS-PAGE. Show all posts

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

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Publication Details

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), 1–6.

Kashish Chaudhary et al. Identification of Teriparatide by Sodium dodecyl sulfate polyacrylamide (SDS-PAGE). Journal of Allbiosolution, 2025, 7(1): 1-6.

K. Chaudhary et al. Identification of Teriparatide by Sodium dodecyl sulfate polyacrylamide (SDS-PAGE). Allbiosolution, 2025, 7(1): 1-6.

Comparative Assessment of Filgrastim Bio-similars via vertical gel electrophoresis (SDS-PAGE) and HPLC

Priyanka Chaudhary 1, Muthusamy Kalaivani 1, Kashish Chaudhary 2, Anubhuti Goyal 1, Meenakshi Dahiya1, Rajeev Singh Raghuvanshi 1

1 Department of Biologics, Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Govt. India, Sector-23, Raj Nagar, Ghaziabad-201 002, India.

2 Department of Biotechnology, Bennett University, India

Abstract

Background: Filgrastim bio-similar have emerged as cost-effective alternatives to the reference filgrastim, providing comparable efficacy and safety profiles. Objective: In this study, we aim to show physico-chemical similarity between filgrastim biosimilars using vertical gel electrophoresis & high-performance liquid chromatography. Materials & Methods: In the present study, we evaluate filgrastim biosimilars (grafeel, religrast, neukine, colstim, emigrast) via SDS-PAGE and HPLC thereby checking their molecular weights for similarity and their qualitative analysis. The same was compared with reference standard of filgrastim (Filgrastim, certified Reference Material). Results: In the scope of the data obtained, we found that the main band of filgrastim in filgrastim biosimilars has the same electrophoretic mobility as the reference standard under non-reduced circumstances in case of SDS-PAGE, the outcomes demonstrated that the position of the principal band in the electropherogram produced by the test solution and the principal band produced by the reference solution are similar. The retention time of the main peak obtained with the test solution and the peak obtained with the reference solution are similar. For HPLC, all the filgrastim biosimilars showed monomer peaks on the RP-HPLC chromatograms, which eluted at 12.4 minutes, matching the retention duration of the filgrastim reference standard. Conclusion: Filgrastim has transformed the management of neutropenia and has become an indispensable therapy in various clinical settings. The development and approval of filgrastim biosimilars have expanded treatment options and improved accessibility, offered cost-effective alternatives while maintained comparable safety and efficacy. .  

Keywords: Filgrastim, Bio-similar, Physicochemical, SDS-PAGE, HPLC.

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Publication
Article ID: O0601027 RA Preprint 
Received: 05/06/2024
Accepted: 19/06/2024
Published: 05/07/2024

DOI: 10.64307/allbiosolutionO0601027

Citations
P. Chaudhary et al. Comparative Assessment of Filgrastim Bio-similars via vertical gel electrophoresis (SDS-PAGE) and HPLC. Journal of Allbiosolution, 2024, 6(1):271-277
P. Chaudhary et al. Comparative Assessment of Filgrastim Bio-similars via vertical gel electrophoresis (SDS-PAGE) and HPLC. Allbiosolution, 2024, 6(1):271-277
 
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