| Title |
Analytical characterization of recombinant hCG and comparative studies with reference product
|
|---|---|
| Published in |
Biologics: Targets & Therapy, January 2018
|
| DOI | 10.2147/btt.s141203 |
| Pubmed ID | |
| Authors |
Rajamannar Thennati, Sanjay Kumar Singh, Nitin Nage, Yena Patel, Sandip Kumar Bose, Vinod Burade, Ranjit Sudhakar Ranbhor |
| Abstract |
Regulatory agencies recommend a stepwise approach for demonstrating biosimilarity between a proposed biosimilar and reference biological product emphasizing for functional and structural characterization to trace if there is any difference which may impact safety and efficacy. We studied the comparative structural and biological attributes of recombinant human chorionic gonadotropin (rhCG), SB005, with reference product, Ovidrel® and Ovitrelle®. Recombiant hCG was approved in 2000 by the US Food and Drug Administration for the induction of final follicular maturation, early luteinization in infertile women as part of assisted reproductive technology program. It is also indicated for the induction of ovulation and pregnancy in ovulatory infertile patients whose cause of infertility is not due to ovarian failure. Primary structure was studied by intact mass analysis, peptide fingerprinting, peptide mass fingerprinting and sequence coverage analysis. Higher order structure was studied by circular dichroism, ultraviolet-visible spectroscopy, fluorescence spectroscopy, and disulfide bridge analysis. Different isoforms of reference product and SB005 were identified using capillary isoelectric focusing and capillary zone electrophoresis. Glycosylation was studied by N-glycan mapping using LC-ESI-MS, point of glycosylation, released glycan analysis using ultra performance liquid chromatography and sialic acid analysis. Product related impurities such as oligomer content analysis and oxidized impurities were studied using size exclusion chromatography and reverse phase high performance liquid chromatography, respectively. Biological activity in term of potency of reference product and SB005 was studied by in vivo analysis. In this study we have compared analytical similarity of recombinant rhCG (SB005) produced at Sun Pharmaceuticals with the reference product with respect to its primary, higher order structure, isoforms, charge variants, glycosylation, sialyation pattern, pharmacodynamic and in vivo efficacy. Our studies show that the in house produced rhCG has a high degree of structural and functional similarity with the reference product available in the market. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 29 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 29 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 6 | 21% |
| Researcher | 5 | 17% |
| Student > Bachelor | 4 | 14% |
| Other | 2 | 7% |
| Student > Ph. D. Student | 2 | 7% |
| Other | 1 | 3% |
| Unknown | 9 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Biochemistry, Genetics and Molecular Biology | 4 | 14% |
| Pharmacology, Toxicology and Pharmaceutical Science | 3 | 10% |
| Agricultural and Biological Sciences | 3 | 10% |
| Medicine and Dentistry | 3 | 10% |
| Chemistry | 2 | 7% |
| Other | 3 | 10% |
| Unknown | 11 | 38% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 13 February 2018.
All research outputs
#17,396,702
of 25,523,622 outputs
Outputs from Biologics: Targets & Therapy
#192
of 285 outputs
Outputs of similar age
#284,725
of 450,458 outputs
Outputs of similar age from Biologics: Targets & Therapy
#3
of 4 outputs
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