Therapeutic monoclonal antibodies approved by FDA in 2017

Cai, Henry Hongrong

doi:10.15406/moji.2018.06.00198

Cited by 6 publications

(3 citation statements)

References 17 publications

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“…Since the development of the hybridoma technology by Köhler and Milstein, monoclonal antibodies (mAbs) have made their way to therapeutic applications, from 10 mAbs approved by the U.S. Food and Drug Administration (FDA) in 2001 to 100 mAbs in 2021 to 153 in 2022 (among which 59 were approved for cancer therapy) . The transition from mouse antibodies to chimeric and eventually to human antibodies has led to a drastically reduced immune reaction and has driven the recent increase in the number of mAbs in use or under development.…”

Section: Introductionmentioning

confidence: 99%

Biophysical Determinants for the Viscosity of Concentrated Monoclonal Antibody Solutions

Mosca,

Pounot,

Beck

et al. 2023

Mol. Pharmaceutics

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Monoclonal antibodies (mAbs) are particularly relevant for therapeutics due to their high specificity and versatility, and mAb-based drugs are hence used to treat numerous diseases. The increased patient compliance of self-administration motivates the formulation of products for subcutaneous (SC) administration. The associated challenge is to formulate highly concentrated antibody solutions to achieve a significant therapeutic effect, while limiting their viscosity and preserving their physicochemical stability. Protein−protein interactions (PPIs) are in fact the root cause of several potential problems concerning the stability, manufacturability, and delivery of a drug product. The understanding of macroscopic viscosity requires an in-depth knowledge on protein diffusion, PPIs, and self-association/aggregation. Here, we study the self-diffusion of different mAbs of the IgG1 subtype in aqueous solution as a function of the concentration and temperature by quasi-elastic neutron scattering (QENS). QENS allows us to probe the short-time self-diffusion of the molecules and therefore to determine the hydrodynamic mAb cluster size and to gain information on the internal mAb dynamics. Small-angle neutron scattering (SANS) is jointly employed to probe structural details and to understand the nature and intensity of PPIs. Complementary information is provided by molecular dynamics (MD) simulations and viscometry, thus obtaining a comprehensive picture of mAb diffusion.

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Section: Introductionmentioning

confidence: 99%

Biophysical Determinants for the Viscosity of Concentrated Monoclonal Antibody Solutions

Mosca,

Pounot,

Beck

et al. 2023

Mol. Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…Monoclonal antibodies are the largest class of biopharmaceuticals and include antibody derivatives such as bispecific antibodies, antibody fragments, and antibody conjugates. Monoclonal antibodies are currently approved for the treatment of a variety of diseases, ranging from rare and orphan indications affecting populations of a few thousand individuals, such as paroxysmal nocturnal hemoglobinuria or the cryopyrin‐associated periodic syndromes, to those affecting hundreds of thousands, including some forms of cancer and multiple sclerosis, and millions, such as asthma and rheumatoid arthritis (Hongrong Cai, 2018). Monoclonal antibodies are also extensively employed for the development of in vivo diagnostics and imaging purposes (Leader et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

Cell factory engineering: Challenges and opportunities for synthetic biology applications

Bachhav

Rossi

Llanos

et al. 2023

Biotech & Bioengineering

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The production of high‐quality recombinant proteins is critical to maintaining a continuous supply of biopharmaceuticals, such as therapeutic antibodies. Engineering mammalian cell factories presents a number of limitations typically associated with the proteotoxic stress induced upon aberrant accumulation of off‐pathway protein folding intermediates, which eventually culminate in the induction of apoptosis. In this review, we will discuss advances in cell engineering and their applications at different hierarchical levels of control of the expression of recombinant proteins, from transcription and translational to posttranslational modifications and subcellular trafficking. We also highlight challenges and unique opportunities to apply modern synthetic biology tools to the design of programmable cell factories for improved biomanufacturing of therapeutic proteins.

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“…MAbs provide a renewable source of preparations with high specificity and standardized potency. Currently, more than 80 FDA approved MAb preparations are available in the market for patients with pathological conditions encompassing from cancer to cardiovascular pathologies[14]. Recent advancement in the passive immunization approach is the use of the chimeric antigen receptor T-cells (CAR T-cells) approach[15].The passive immunization approach may be given serious consideration as a viable option to passively immunize the 2019-nCoV infected patients by convalescent serum therapy wherein serum obtained from the patients who have survived and recovered from the infection can be used[16].Passive immunization offers the patient a short-lived protection, which may vary in duration from a few weeks to a few months.…”

mentioning

confidence: 99%

Combating 2019-nCoV Amidst the Pandemic Scare

Haider¹,

Hyder²

2020

OJRM

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2019-nCoV is the third consecutive coronavirus spread during the last 2 decades, but this time, unlike the previous two occasions, has achieved a pandemic proportion threatening widespread loss of human lives and a massive setback to the global economy. The situation warrants drastic measures in terms of preventing the spread of the virus and treating the virus-infected patients. The development of a new vaccine is a time-intensive option. Although efforts are underway to find possible pharmacological options, e.g., chloroquine, hydroxychloroquine, existing antiviral agents, etc., in the meanwhile we may work on the combinatorial interventional approach of combining drug therapy with passive immune therapy. It would be prudent to use a convalescent serum therapy approach with the serum from COVID-19 patients who have recovered from the infection.

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Therapeutic monoclonal antibodies approved by FDA in 2017

Cited by 6 publications

References 17 publications

Biophysical Determinants for the Viscosity of Concentrated Monoclonal Antibody Solutions

Biophysical Determinants for the Viscosity of Concentrated Monoclonal Antibody Solutions

Cell factory engineering: Challenges and opportunities for synthetic biology applications

Combating 2019-nCoV Amidst the Pandemic Scare

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