LC-MS/MS Bioanalytical Method Development Strategy for Therapeutic Monoclonal Antibodies in Preclinical Studies

2017 ◽  
pp. 145-159 ◽  
Author(s):  
Hongyan Li ◽  
Timothy Heath ◽  
Christopher A. James
Keyword(s):  
Monoclonal Antibodies ◽  
Development Strategy ◽  
Method Development ◽  
Preclinical Studies ◽  
Bioanalytical Method ◽  
Therapeutic Monoclonal Antibodies

A generic bioanalytical method development strategy and fit-for-purpose qualification to supporthERG in vitrosample analysis

Bioanalysis ◽  
2011 ◽  
Vol 3 (24) ◽  
pp. 2739-2745 ◽  
Author(s):  
Paul Holme ◽  
Kirsty Payne ◽  
Sonia Smith ◽  
Mike Spence
Keyword(s):  
Development Strategy ◽  
Method Development ◽  
Bioanalytical Method ◽  
Fit For Purpose

scholarly journals Generic MS-based method for the bioanalysis of therapeutic monoclonal antibodies in nonclinical studies

Bioanalysis ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 231-243 ◽  
Author(s):  
Noritaka Hashii ◽  
Yoshiko Tousaka ◽  
Koji Arai ◽  
Ryoya Goda ◽  
Noriko Inoue ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Stable Isotope ◽  
Calibration Curve ◽  
Animal Studies ◽  
Collaborative Study ◽  
Internal Standard ◽  
Selected Reaction Monitoring ◽  
Bioanalytical Method ◽  
Validation Parameters ◽  
Therapeutic Monoclonal Antibodies

Aim: A generic bioanalytical method was developed to quantify therapeutic IgG1 monoclonal antibodies (mAbs) in mouse sera by combining an easy sample preparation method with LC/MS using selected reaction monitoring. Materials & methods: Rituximab and trastuzumab were used as model mAbs. A synthetic stable isotope-labeled peptide or a stable isotope-labeled mAb was used as an internal standard. The method feasibility was evaluated by a collaborative study involving six laboratories. Results: The calibration curve ranged from 1.0 to 1000.0 μg/ml (correlation coefficient >0.99). The validation parameters including selectivity, linearity of calibration curve, accuracy and precision met the predefined acceptance criteria. Conclusion: Our method is a useful bioanalytical method for the quantification of therapeutic IgG mAbs in nonclinical animal studies.

Design of Innovative Therapeutic Monoclonal Antibodies

2017 ◽  
pp. 10-29
Author(s):  
A.V. Karabelskii ◽  
◽  
T.A. Nemankin ◽  
A.B. Ulitin ◽  
A.S. Vaganov ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Therapeutic Monoclonal Antibodies

Therapeutic Monoclonal Antibodies in Clinical Practice against Cancer

2020 ◽  
Vol 20 (16) ◽  
pp. 1895-1907
Author(s):  
Navgeet Kaur ◽  
Anju Goyal ◽  
Rakesh K. Sindhu
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Clinical Practice ◽  
Therapeutic Agent ◽  
Hematologic Malignancies ◽  
Immune Checkpoints ◽  
Malignant Cells ◽  
Main Target ◽  
Therapeutic Monoclonal Antibodies ◽  
Cancerous Cells

The importance of monoclonal antibodies in oncology has increased drastically following the discovery of Milstein and Kohler. Since the first approval of the monoclonal antibody, i.e. Rituximab in 1997 by the FDA, there was a decline in further applications but this number has significantly increased over the last three decades for various therapeutic applications due to the lesser side effects in comparison to the traditional chemotherapy methods. Presently, numerous monoclonal antibodies have been approved and many are in queue for approval as a strong therapeutic agent for treating hematologic malignancies and solid tumors. The main target checkpoints for the monoclonal antibodies against cancer cells include EGFR, VEGF, CD and tyrosine kinase which are overexpressed in malignant cells. Other immune checkpoints like CTLA-4, PD-1 and PD-1 receptors targeted by the recently developed antibodies increase the capability of the immune system in destroying the cancerous cells. Here, in this review, the mechanism of action, uses and target points of the approved mAbs against cancer have been summarized.

scholarly journals COVID-19: Unmasking Emerging SARS-CoV-2 Variants, Vaccines and Therapeutic Strategies

Biomolecules ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 993
Author(s):  
Renuka Raman ◽  
Krishna J. Patel ◽  
Kishu Ranjan
Keyword(s):  
Immune Response ◽  
Monoclonal Antibodies ◽  
Severe Acute Respiratory Syndrome ◽  
Small Molecules ◽  
Viral Vector ◽  
Therapeutic Strategies ◽  
Convincing Evidence ◽  
Plasma Therapy ◽  
Therapeutic Monoclonal Antibodies ◽  
Increased Susceptibility

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological agent of the coronavirus disease 2019 (COVID-19) pandemic, which has been a topic of major concern for global human health. The challenge to restrain the COVID-19 pandemic is further compounded by the emergence of several SARS-CoV-2 variants viz. B.1.1.7 (Alpha), B.1.351 (Beta), P1 (Gamma) and B.1.617.2 (Delta), which show increased transmissibility and resistance towards vaccines and therapies. Importantly, there is convincing evidence of increased susceptibility to SARS-CoV-2 infection among individuals with dysregulated immune response and comorbidities. Herein, we provide a comprehensive perspective regarding vulnerability of SARS-CoV-2 infection in patients with underlying medical comorbidities. We discuss ongoing vaccine (mRNA, protein-based, viral vector-based, etc.) and therapeutic (monoclonal antibodies, small molecules, plasma therapy, etc.) modalities designed to curb the COVID-19 pandemic. We also discuss in detail, the challenges posed by different SARS-CoV-2 variants of concern (VOC) identified across the globe and their effects on therapeutic and prophylactic interventions.

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