scholarly journals Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

2016 ◽  
Vol 5 (2) ◽  
pp. 70-73 ◽  
Author(s):  
Paul Declerck ◽  
Paul W Tebbey
2020 ◽  
Vol 10 (3) ◽  
pp. 79 ◽  
Author(s):  
Apostolos Papachristos ◽  
Gregory B. Sivolapenko

Bevacizumab is a monoclonal antibody that targets VEGF-A and inhibits tumor angiogenesis. Bevacizumab is approved for the treatment of various cancer, including metastatic colorectal cancer (mCRC), ovarian cancer, lung cancer, and others. Thus, it is widely used in oncology, but contrary to other therapeutic classes, there is still a lack of validating predictive factors for treatment outcomes with these agents. In recent years, the research for factors predictive of anti-VEGF treatments and especially bevacizumab response has been one of the most competitive translational research fields. Herein, we review and present the available literature of the clinical use of biomarkers, pharmacogenomics (PG), and therapeutic drug monitoring (TDM) approaches that can be used for the optimization of bevacizumab use in the era of precision medicine.


1988 ◽  
Vol 3 (3) ◽  
pp. 147-153 ◽  
Author(s):  
E.F.H. van der Linden ◽  
M.J.P.G. van Kroonenburgh ◽  
E.K.J. Pauwels

This literature review presents an inventory of the nature and incidence of side-effects that arise from the clinical application of monoclonal antibodies (MoAb) for the diagnosis and treatment of cancer. Most side-effects occurred during therapy. Toxic reactions, such as fever, sweating and chills, were more common than immunological skin reactions; they were observed predominantly in association with the elimination of circulating target cells. Dosage and rate of administration of the MoAb appeared to have little influence on the reactions, which disappeared quickly and did not necessitate discontinuation of treatment. Serum sickness, anaphylactic reactions and bronchospasms were not common; the patients reacted quickly to the indicated therapy. Prevention of the side-effects described here, especially during diagnostic applications, was such that they need not form a barrier to the clinical use of MoAb.


1988 ◽  
Vol 547 (1 Bombesin-Like) ◽  
pp. 360-372 ◽  
Author(s):  
JAMES L. MULSHINE ◽  
INGALILL AVIS ◽  
ANTHONY M. TRESTON ◽  
CYNTHIA MOBLEY ◽  
PHILIP KASPRZYK ◽  
...  

2016 ◽  
Vol 40 (5) ◽  
pp. 1055-1060 ◽  
Author(s):  
Nicolas Bilbey ◽  
Philipp Blanke ◽  
Christopher Naoum ◽  
Chesnel Dey Arepalli ◽  
Bjarne Linde Norgaard ◽  
...  

2021 ◽  
Author(s):  
Henning Gruell ◽  
Kanika Vanshylla ◽  
Pinkus Tober-Lau ◽  
David Hillus ◽  
Philipp Schommers ◽  
...  

The Omicron variant of SARS-CoV-2 is causing a rapid increase in infections in various countries. This new variant of concern carries an unusually high number of mutations in key epitopes of neutralizing antibodies on the spike glycoprotein, suggesting potential immune evasion. Here we assessed serum neutralizing capacity in longitudinal cohorts of vaccinated and convalescent individuals, as well as monoclonal antibody activity against Omicron using pseudovirus neutralization assays. We report a near-complete lack of neutralizing activity against Omicron in polyclonal sera after two doses of the BNT162b2 vaccine, in convalescent individuals, as well as resistance to different monoclonal antibodies in clinical use. However, mRNA booster immunizations in vaccinated and convalescent individuals resulted in a significant increase of serum neutralizing activity against Omicron. Our study demonstrates that booster immunizations will be critical to substantially improve the humoral immune response against the Omicron variant.


2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 127-127
Author(s):  
Maxim Izquierdo ◽  
Ignacio Rodriguez ◽  
Fransec Tresserra ◽  
Rafael Fabregas

127 Background: Proliferative tumor activity measured immunohistochemically by Ki67 has high variability. Clinical use can be improved if it is considered together with the histological grade. Methods: Ki67 value has been studied in 566 breast cancers between 2007 and 2013 at our Institution using MIBI monoclonal antibody. The histological grade and hormonal receptor status were also evaluated. Results: Histological grade was I in 293 (51.7%) tumors, II in 219 (38.7%) and III in 54 (16.8%) tumors. Estrogen receptor was positive in 166 (29.5%) tumors and progesterone receptor was positive in 95 (16.8%) tumors. None of the tumors with Ki 67 value lower than 10% had histological grade III. Only 7% of tumors with histological grade I had a Ki 67 higher than 25%. Conclusions: It has to be considered to repeat or confirm the values of Ki67 higher than 25% with histological grade I, and Ki67 values lower than 10% in tumors with histological grade III.


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