SynthesismAbs
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations.
Synthesis in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 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
40 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Article
- Article
- Review
- Polar vs Non-polar Excipients in BSA Aggregation.Pharmaceutical research · 2026Article
- Enhancing Bioavailability of Ultra-High Concentration Antibody Formulations Using Ionic Liquids.Advanced healthcare materials · 2026Article
- Engineering the subcutaneous delivery of antibody-drug conjugates.Journal of controlled release : official journal of the Controlled Release Society · 2026Article
- Predicting Agitation Stability of Monoclonal Antibodies during Developability Assessment.Molecular pharmaceutics · 2026Article
- From permeation enhancer to therapeutic enabler: Advances, applications, and translational perspectives in hyaluronidase-based drug delivery.Materials today. Bio · 2026Review
- Impact of Amino Acid Excipients on icIEF Method Development in Protein Therapeutics: A Formulation-Aware Analytical Framework.AAPS PharmSciTech · 2026Article
- The Impact of Particle Properties on High Concentration Suspension Performance and Stability of Spray-Dried Monoclonal Antibodies.Pharmaceutical research · 2026Article
- Lyophilized mesenchymal stromal cell-derived extracellular vesicles for the oral treatment of inflammatory bowel disease: a novel cell-free therapeutic strategy.Stem cell research & therapy · 2026Article
- 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
- Optical imaging and spectroscopic characterization of subvisible particles in protein therapeutics.Advanced drug delivery reviews · 2026Review
- Monoclonal antibody formulations: a quantitative analysis of marketed products and patents.mAbs · 2025Article
- Review
- 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
- Bayesian Optimization for Efficient Multiobjective Formulation Development of Biologics.Molecular pharmaceutics · 2025Article
- Fifty years of monoclonals: the past, present and future of antibody therapeutics.Nature reviews. Immunology · 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
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration. HCAPs have become successful in the therapeutic sector due to their unique advantage of allowing subcutaneous self-administration. Technical challenges, such as physical and chemical instability, viscosity, delivery volume limitations, and product immunogenicity, can hinder successful development and commercialization of HCAPs. Such challenges can be overcome by robust formulation and process development strategies, as well as rational selection of excipients and packaging components. We compiled and analyzed data from US Food and Drug Administration-approved and marketed HCAPs that are ≥100 mg/mL to identify trends in formulation composition and quality target product profile. This review presents our findings and discusses novel formulation and processing technologies that enable the development of improved HCAPs at ≥200 mg/mL. The observed trends can be used as a guide for further advancements in the development of HCAPs as more complex antibody-based modalities enter biologics product development.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.