Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Neh Nupur"'
Publikováno v:
Frontiers in Bioengineering and Biotechnology, Vol 10 (2022)
Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry. Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with currently over 200 approved biosimilars, globally. The key step towards achie
Externí odkaz:
https://doaj.org/article/c681cfcfdedc473ca7d2a3785df78f2f
Autor:
Anurag S, Rathore, Srishti, Joshi, Neh, Nupur, Nikita, Saxena, Sanghati, Bhattacharya, Souhardya, Roy
Publikováno v:
International Journal of Biological Macromolecules. 227:124-133
Biosimilar manufacturers need to perform analytical and functional similarity assessments against the reference product. Successful demonstration allows for an abbreviated clinical path, thereby translating to affordable biosimilars. Current practice
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d6a5b4339e84cce71592c20b945f1899
https://doi.org/10.1016/j.ijbiomac.2022.12.011
https://doi.org/10.1016/j.ijbiomac.2022.12.011
Publikováno v:
J Diabetes Sci Technol
Background: A biosimilar product is expected to exhibit similar safety, efficacy, and quality as that of the approved reference product. Only a few reports of thorough evaluation of the quality of insulin glargine biosimilars are available in literat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f6323eedf3ce48c9cb62ce1d02d196f9
https://pubmed.ncbi.nlm.nih.gov/34852652
https://pubmed.ncbi.nlm.nih.gov/34852652
Autor:
Anurag S. Rathore, Neh Nupur
Publikováno v:
Analytical and Bioanalytical Chemistry. 411:2867-2883
With the number of approved biosimilars rapidly increasing in the various regulatory jurisdictions, public perception of safety and efficacy of these products have been gradually improving. Establishment of analytical similarity with the innovator pr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::fc63ed6955b824418d99111e9b00f734
https://doi.org/10.1007/s00216-019-01735-z
https://doi.org/10.1007/s00216-019-01735-z
Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study
Publikováno v:
mAbs. 10:143-158
Biosimilars are products that are similar in terms of quality, safety, and efficacy to an already licensed reference/ innovator product and are expected to offer improved affordability. The most significant source of reduction in the cost of developm
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::11ed9a16281be03d1f781eb34cb3a2f0
https://doi.org/10.1080/19420862.2017.1402996
https://doi.org/10.1080/19420862.2017.1402996
Autor:
Neh, Nupur, Anurag S, Rathore
Publikováno v:
Analytical and bioanalytical chemistry. 411(13)
With the number of approved biosimilars rapidly increasing in the various regulatory jurisdictions, public perception of safety and efficacy of these products have been gradually improving. Establishment of analytical similarity with the innovator pr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::e5a8a646fe7a2c67c47bd5dbf3f0d357
https://pubmed.ncbi.nlm.nih.gov/30859268
https://pubmed.ncbi.nlm.nih.gov/30859268
Publikováno v:
Biosimilars ISBN: 9783319996790
The ever-increasing cost of healthcare together with our improved understanding of biotech therapeutic drugs has fueled the rise of biosimilars. A step towards achieving the successful development of a biosimilar is to establish analytical similarity
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::c9795029acf0f98fd6bab802019a9e31
https://doi.org/10.1007/978-3-319-99680-6_24
https://doi.org/10.1007/978-3-319-99680-6_24
Publikováno v:
Recent patents on biotechnology. 10(1)
Background: Penicillin G amidase (PGA) (EC 3.5.1.11) are enzymes that are mainly involved in the synthesis of semi-synthetic }-lactam antibiotics. Soluble PGA is costly and lacks long term operational stability. We revised most of the patents related
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5289cfcc535162bf64a5d5dd74c034d4
https://pubmed.ncbi.nlm.nih.gov/27494735
https://pubmed.ncbi.nlm.nih.gov/27494735
Publikováno v:
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 1032
The biosimilar industry is witnessing an unprecedented growth with the newer therapeutics increasing in complexity over time. A key step towards development of a biosimilar is to establish analytical comparability with the innovator product, which wo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cca0e8cd33a61a7b62e81b6fa1a5d18b
https://pubmed.ncbi.nlm.nih.gov/27289250
https://pubmed.ncbi.nlm.nih.gov/27289250
Publikováno v:
Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges ISBN: 9788132228356
Biomarker discovery has been one of the central foci of proteomic research globally. However, in developing countries, the road map to achieving this is not very straightforward. Biomarker post regulatory checks are often known to be sold at exorbita
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::d95afbc549beb2244ec097d89bce4847
https://doi.org/10.1007/978-81-322-2837-0_7
https://doi.org/10.1007/978-81-322-2837-0_7