ReviewAntibody therapeutics2021
US FDA-approved therapeutic antibodies with high-concentration formulation: summaries and perspectives.
Review in Antibody therapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Review
- Radiation-Induced Modifications in Bovine Serum Albumin in Saline Solutions Under E-Beam Irradiation.International journal of molecular sciences · 2026Article
- Subcutaneous administration of antibody-drug conjugates: current challenges, emerging opportunities, and future perspectives.Antibody therapeutics · 2026Review
- Mechanistic insight into the oxidative degradation of monoclonal antibodies: relevance to developability and the design of stable pharmaceutical formulations.Biochemical Society transactions · 2026Review
- Recent Advances in Particle Design for High-Concentration Protein Suspension Injectables.Pharmaceutics · 2026Review
- Fab-Fc and Fab-Fab interactions of variable strength and valency contribute to the high concentration viscosity of IgGProceedings of the National Academy of Sciences of the United States of America · 2026Article
- Polymers as Stabilizing Excipients for Spray-Dried Protein Formulations.Pharmaceutical research · 2026Article
- Mechanistic insights into the impact of prenatal viral infections on maternal and offspring immunity.Npj viruses · 2026Review
- Generation of a Human-Mouse Chimeric Anti-Japanese Encephalitis Virus and Zika Virus Monoclonal Antibody Using CDR Grafting.Microorganisms · 2025Article
- Article
- Article
- Monoclonal antibody formulations: a quantitative analysis of marketed products and patents.mAbs · 2025Article
- High-concentration L-methionine as a potent antioxidant for oxidation resistance and stability enhancement in high-concentration antibody therapeutics.International journal of pharmaceutics: X · 2025Article
- Ultrahigh-concentration biologic therapeutics enabled by spray drying with a glassy surfactant excipient.Science translational medicine · 2025Article
- Developing high-concentration monoclonal antibody formulations for subcutaneous administration to improve patient treatment.Biophysical reviews · 2025Review
- Investigating Zinc Migration from Rigid Needle Shield to Drug Formulation in Needle Tip of Pre-filled Syringe.Pharmaceutical research · 2025Article
- Innovative Formulation Strategies for Biosimilars: Trends Focused on Buffer-Free Systems, Safety, Regulatory Alignment, and Intellectual Property Challenges.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Vaginally-delivered fast-dissolving antibody tablets (FDAT) for on-demand non-hormonal contraception and multi-purpose protection.Journal of controlled release : official journal of the Controlled Release Society · 2025Article
- Investigating the Interaction between Excipients and Monoclonal Antibodies PGT121 and N49P9.6-FR-LS: A Comprehensive Analysis.Molecular pharmaceutics · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Thirty four (34) of the total US FDA approved 103 therapeutic antibody drugs, accounts for one third of the total approved mAbs, are formulated with high protein concentration (100 mg/mL or above) which are the focus of this article. The highest protein concentration of these approved mAbs is 200 mg/mL. The dominant administration route is subcutaneous (76%). Our analysis indicates that it may be rational to implement a platform formulation containing polysorbate, histidine and sucrose to accelerate high concentration formulation development for antibody drugs. Since 2015, the FDA approval numbers are significantly increased which account for 76% of the total approval numbers, i.e., 26 out of 34 highly concentrated antibodies. Thus, we believe that the high concentration formulations of antibody drugs will be the future trend of therapeutic antibody formulation development, regardless of the challenges of highly concentrated protein formulations.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.