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  1. Article ; Online: NMR based quality evaluation of mAb therapeutics: A proof of concept higher order structure biosimilarity assessment of trastuzumab biosimilars.

    Joshi, Srishti / Khatri, Lakshya Raj / Kumar, Ashutosh / Rathore, Anurag S

    Journal of pharmaceutical and biomedical analysis

    2022  Volume 214, Page(s) 114710

    Abstract: Higher-order structural (HOS) biosimilarity assessment is a regulatory requirement for intended biosimilars, and manufacturers are required to demonstrate the biosimilarity of their product in comparison to the reference product concerning both safety ... ...

    Abstract Higher-order structural (HOS) biosimilarity assessment is a regulatory requirement for intended biosimilars, and manufacturers are required to demonstrate the biosimilarity of their product in comparison to the reference product concerning both safety and efficacy. NMR has recently emerged as a powerful technique for complex biologics such as mAbs that offers holistic Higher-order structure (HOS) assessment. In this paper, a proof-of-concept for similarity assessment for marketed biosimilars of trastuzumab has been presented using both 1Dimensional (
    MeSH term(s) Antibodies, Monoclonal/chemistry ; Biosimilar Pharmaceuticals/chemistry ; Excipients ; Magnetic Resonance Spectroscopy ; Trastuzumab
    Chemical Substances Antibodies, Monoclonal ; Biosimilar Pharmaceuticals ; Excipients ; Trastuzumab (P188ANX8CK)
    Language English
    Publishing date 2022-03-11
    Publishing country England
    Document type Journal Article
    ZDB-ID 604917-5
    ISSN 1873-264X ; 0731-7085
    ISSN (online) 1873-264X
    ISSN 0731-7085
    DOI 10.1016/j.jpba.2022.114710
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1850: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Monitoring size and oligomeric-state distribution of therapeutic mAbs by NMR and DLS: Trastuzumab as a case study.

    Joshi, Srishti / Khatri, Lakshya Raj / Kumar, Ashutosh / Rathore, Anurag S

    Journal of pharmaceutical and biomedical analysis

    2020  Volume 195, Page(s) 113841

    Abstract: Monoclonal antibodies (mAbs) are the modalities of choice for immunotherapy. This class of products are known to exhibit considerable heterogeneity with respect to size, aggregation states, and charge. This makes it challenging for biopharmaceutical ... ...

    Abstract Monoclonal antibodies (mAbs) are the modalities of choice for immunotherapy. This class of products are known to exhibit considerable heterogeneity with respect to size, aggregation states, and charge. This makes it challenging for biopharmaceutical manufacturers, in particular biosimilar producers, to maintain consistency in product quality. In order to fingerprint these biotherapeutic products, multiple, high-resolution analytical tools are used to characterize the numerous critical quality attributes. Recently, there has been growing interest in enhancing adaptability of 1D and 2D NMR platforms for characterization of higher order structure with emphasis on 1D
    MeSH term(s) Antibodies, Monoclonal ; Biosimilar Pharmaceuticals ; Dynamic Light Scattering ; Magnetic Resonance Spectroscopy ; Trastuzumab
    Chemical Substances Antibodies, Monoclonal ; Biosimilar Pharmaceuticals ; Trastuzumab (P188ANX8CK)
    Language English
    Publishing date 2020-12-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 604917-5
    ISSN 1873-264X ; 0731-7085
    ISSN (online) 1873-264X
    ISSN 0731-7085
    DOI 10.1016/j.jpba.2020.113841
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1850: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Mapping of Methyl Epitopes of a Peptide-Drug with Its Receptor by 2D STDD-Methyl TROSY NMR Spectroscopy.

    Dey, Anomitra / Mitra, Debarghya / Rachineni, Kavitha / Khatri, Lakshya Raj / Paithankar, Harshad / Vajpai, Navratna / Kumar, Ashutosh

    Chembiochem : a European journal of chemical biology

    2022  Volume 23, Issue 23, Page(s) e202200489

    Abstract: The current trend in the biopharmaceutical market has boosted the development and production of biological drugs with high efficacy and fidelity for receptor binding. While high-resolution structural insights into binding epitopes of the receptor are ... ...

    Abstract The current trend in the biopharmaceutical market has boosted the development and production of biological drugs with high efficacy and fidelity for receptor binding. While high-resolution structural insights into binding epitopes of the receptor are indispensable for better therapeutic design, it is tedious and costly. In this work, we develop a protocol by integrating two well-known NMR-based solution-state methods. Saturation transfer double-difference with methyl-TROSY (STDD-Methyl TROSY NMR) was used to probe methyl binding epitopes of the ligand in a label-free environment. This study was carried out with Human insulin as a model peptide drug, with the insulin growth factor receptor (IGFR), which is an off-target receptor for insulin. Methyl epitopes identified from STDD-Methyl TROSY NMR spectroscopy were validated through the HADDOCK platform to generate a drug-receptor model. Since this method can be applied at natural abundance, it has the potential to screen a large set of peptide-drug interactions for optimum receptor binding. Thus, we propose STDD-Methyl TROSY NMR spectroscopy as a technique for rapid screening of biologics for the development of optimized biopharmaceutics.
    MeSH term(s) Humans ; Epitopes ; Magnetic Resonance Spectroscopy/methods ; Ligands ; Peptides ; Insulins ; Nuclear Magnetic Resonance, Biomolecular/methods
    Chemical Substances Epitopes ; Ligands ; Peptides ; Insulins
    Language English
    Publishing date 2022-11-10
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2020469-3
    ISSN 1439-7633 ; 1439-4227
    ISSN (online) 1439-7633
    ISSN 1439-4227
    DOI 10.1002/cbic.202200489
    Database MEDical Literature Analysis and Retrieval System OnLINE

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