Aggregation Control in Antibody Formulation Patents: Leaders & Trends 2026
- Filing peaked in 2021 at 5 records and has since fallen to 2 by 2024, a -60% swing that predates the usual 18-month publication lag on the most recent years.
- A dye-and-detection cluster dominates the most-cited prior art, with the top five most-cited records all describing dyes or excipients for tracking or stabilizing protein aggregation rather than formulation chemistry itself.
- The leader holds 9 records against a fifth-place count of 7 and a tenth-place count of 4, showing a short concentrated head rather than a single dominant monopoly position.
Filing growth compares 2021 (5 records) with 2024 (2) — a three-year span. 2024 is the most recent year we treat as complete: publication lags filing by roughly 18 months, so 2025 onwards are still filling in and any growth rate that ends there would understate the field.
What this landscape covers
Antibody formulation stability is a persistent bottleneck in biologics development: aggregation during freeze-thaw cycling, agitation, or long-term storage can compromise both efficacy and safety. This landscape draws on 49 published patent records filed or published between 2015 and 2026 that describe methods for detecting, measuring, or suppressing protein aggregation — spanning excipient screening, subvisible particle analysis, surfactant degradation, and reversible self-association work. The scope captures both the analytical tools used to characterize aggregation and the formulation interventions meant to prevent it.
Because publication typically lags filing by roughly 18 months, the 2025 and 2026 figures in this dataset are still incomplete and should not be read as a decline in real filing activity.
Filing trend and technology composition
The 49 records in scope split across analytical, therapeutic and chemical IPC subclasses, with material testing methods appearing more often than formulation chemistry itself.
A 2021 peak followed by a real pullback
Filings rose to a peak of 5 in 2021, then fell to 2 by 2024 – a decline of 60% over that three-year span. This is the most recent stretch of years complete enough to trust; 2025 and 2026 are still filling in under the usual publication lag.
Testing methods outweigh formulation claims
G01N (material analysis and testing) appears in 46.9% of the 49 records, ahead of A61K (medicinal preparations) at 42.9% and C07K (peptides and proteins) at 30.6%. Because records can carry multiple IPC classes, these shares sum to well over 100% – the concentration in G01N signals that a large share of the field's activity is analytical instrumentation and assay method claims, not formulation composition claims.
Shares are the percentage of the 49 records in scope. A patent can carry several IPC classes, so the shares add up to more than 100%.
Go deeper on Aggregation Control in Antibody Formulation with Eureka
This page is one run against one query. Ask Eureka your own question about aggregation control in antibody formulation and every answer comes back with the patent numbers behind it.
Try EurekaThe prior art that shapes freedom to operate
Dyes for analysis of protein aggregation (US20130137112A1)
Provided are dyes and compositions which are useful in a number of applications, such as the detection and monitoring protein aggregation, kinetic studies of protein aggregation, neurofibrillary plaques analysis, evaluation of protein formulation stability, and analysis of molecular chaperone activity.Filed by Enzo Life Sciences, this record sits inside a small cluster of related dye patents from the same applicant family that together account for several of the most-cited documents in this landscape.
| # | Publication no. | Patent title | Citations |
|---|---|---|---|
| 1 | WO2009026729A1 | Amino acid pairing-based self assembling peptides and methods | 50 |
| 2 | US20110130305A1 | Novel dyes and compositions, and processes for using same in analysis of protein aggregation and other applic… | 44 |
| 3 | WO2011065980A2 | DYES for analysis of protein aggregation | 42 |
| 4 | US20110046052A1 | Excipients for Protein Stabilization | 36 |
| 5 | US20130137112A1 | Dyes for analysis of protein aggregation | 13 |
| 6 | US20180273759A1 | Dyes for analysis of protein aggregation | 4 |
| 7 | US9133343B2 | Dyes and compositions, and processes for using same in analysis of protein aggregation and other applications | 4 |
| 8 | CA2697951A1 | Amino acid pairing-based self assembling peptides and methods | 3 |
| 9 | US20210009809A1 | Dyes for analysis of protein aggregation | 2 |
| 10 | US20180317536A1 | Food-improving agent | 2 |
Citation counts favor older records inside any searched corpus; treat them as a signal of influence on subsequent filings, not as a measure of current commercial relevance.
Each row carries its publication number; clicking a row searches Eureka by that number.
Put your own technology through the same analysis
Eureka on the web
When you want the answer in the next five minutes.
The agent works the prompt against patents and technical literature, citing every source.
Run your analysis now →MCP server & REST API
When it has to run inside your own pipeline.
Patent search, landscape analysis and assignee resolution as MCP tools. Drop them into any agent framework, or call REST directly.
Browse MCP servers →What the numbers mean for filing strategy
The dataset points to a field where detection and characterization tools have drawn more patent activity than the formulation interventions they support.
The peak has passed, but the runway isn't clear yet
Filings dropped from 5 in 2021 to 2 in 2024. That is a real decline over a complete three-year window, not an artifact of publication lag – though any read on 2025 and 2026 numbers should wait for those years to finish filling in.
Analytical methods outnumber formulation claims
G01N material-testing claims appear in nearly half of records, ahead of A61K medicinal-preparation claims at 42.9%. A field this weighted toward measurement and detection suggests assay and instrumentation claims are more contested ground than excipient formulation itself.
A small dye-patent cluster anchors the prior art
The most-cited records in this landscape – led by a self-assembling peptide patent at 50 citations – are dominated by dye chemistry and detection methods rather than formulation composition, meaning freedom-to-operate risk concentrates around measurement techniques.
Eureka can read the same corpus for gaps instead of for coverage: under-claimed branches adjacent to aggregation control in antibody formulation, with the prior art for and against each one.
Who is filing, and where the gaps sit
The ranking covers 27 companies and individual inventors, counted in records – a short head followed by a long tail rather than a single dominant assignee.
A modest lead, not a monopoly
The top-ranked assignee holds 9 records against 7 at fifth place and 4 at tenth – a gap that narrows quickly, which means the field has not consolidated around one dominant filer the way some mature pharma sub-fields have.
A tight inventor cluster drives citation strength
Three individual inventors – linked in pairs with a co-filing strength of 10 each – form the densest collaboration cluster in the dataset, overlapping with the dye-chemistry patents that also lead the citation table.
No leader shows fresh-year filings yet
Every one of the assignees tracked for recent momentum, including Amgen and Forschungszentrum Julich, shows zero records in the latest year – consistent with publication lag rather than an actual stop in R&D activity.
| Assignee | Recent year | YoY |
|---|---|---|
| PATTON WAYNE FORREST | 0 | — |
| LUDLAM ANTHONY | 0 | — |
| ENZO LIFE SCIENCES INC | 0 | — |
| DAI LIJUN | 0 | — |
| Amgen Inc. | 0 | — |
| Forschungszentrum Julich GmbH | 0 | — |
| YARMOLUK SERGIY M | 0 | — |
| VOLKOVA KATERYNA | 0 | — |
Where to take this analysis
The dataset flags where claim density sits and where it thins out – the next step is testing a specific formulation or detection approach against that map.
Map a candidate formulation against the cited prior art
Run a specific excipient or stabilizer combination against the dye-chemistry and excipient patents that anchor this landscape's citation table before committing to a formulation direction.
Explore in EurekaWatch the under-claimed detection branches
Subvisible particle sizing and surfactant degradation detection show thinner coverage than the core G01N cluster – worth monitoring for new entrants before the space fills in.
Explore in EurekaTrack assignee momentum past the publication lag
Every tracked leader shows zero filings in the latest year, which reflects the 18-month publication delay more than a real stop – revisit this once 2025-2026 data completes.
Explore in EurekaCommon questions on this landscape
It refers to a cluster of patented methods and compositions aimed at detecting, measuring, or preventing the clumping of antibody proteins during manufacturing, storage, or shipping. This landscape's 49 records split between analytical tools – dyes, assays, and particle-sizing methods under IPC class G01N – and formulation interventions such as excipient selection under A61K and C07K. Most patents in this space claim either a detection method or a stabilizing composition, rather than a full manufacturing process.
The ranking covers 27 assignees, counted in records, with the leader holding 9 records and a fifth-place holder at 7. This is a short concentrated head rather than one company controlling the field outright, since the gap from first to fifth place is only two records. Individual inventors as well as corporate assignees such as Amgen and Novartis appear in the ranked list, reflecting the mix of academic, individual, and industrial filers typical of an analytical-methods-heavy niche.
Filings peaked at 5 records in 2021 and had fallen to 2 by 2024, a decline of 60% over that complete three-year window. Because patent publication lags filing by roughly 18 months, the 2025 and 2026 figures in the dataset are still incomplete and should not yet be read as a continued slowdown. The safest read is that the field cooled after 2021, with the true 2025-2026 trajectory not yet visible.
US20130137112A1, assigned to Enzo Life Sciences, claims dyes and compositions used to detect and monitor protein aggregation, including kinetic studies, formulation stability evaluation, and molecular chaperone activity analysis. It sits within a family of related Enzo dye patents that also appear among the most-cited records in this landscape, including WO2009026729A1, US20110130305A1, and WO2011065980A2. Anyone building an aggregation-detection assay using dye-based fluorescence methods should review this cluster closely, since it anchors a large share of the citation graph in this field.
IPC coverage thins out in branches like A23L (foods and non-alcoholic beverages, at 8.2% of the 49 records) and A61M (devices for body fluids, at 10.2%), compared to the dense G01N and A61K clusters that dominate the field. Sub-areas such as reversible self-association kinetics, surfactant degradation byproduct detection, and freeze-thaw stress excipient pairing show comparatively thin claim density relative to the core detection-method cluster. These are reasonable areas to scout for open claim space, though thin coverage in a 49-record dataset also just reflects a smaller pool overall, not necessarily a wide-open field.
Research Aggregation Control in Antibody Formulation in depth with Eureka
Go past this page: query the whole aggregation control in antibody formulation corpus yourself, in your own scope.
Every answer comes back with patent numbers you can open.
Disclaimer. This page is generated from Patsnap Eureka data drawn from a limited snapshot of global patent and scientific-literature records, and is provided for general information and reference only.
Patent data carries inherent limitations: recent filings (typically the most recent 18–24 months) are under-counted due to standard publication lag; counts may be reported at either a patent-family or a patent-record basis and are not always directly comparable; classification, applicant-name, and citation data may contain errors, duplicates, or omissions; and the underlying search query defines and constrains the scope shown. As a result, the analysis may be incomplete or inaccurate and may not reflect the full technology landscape.
Nothing on this page constitutes an exhaustive prior-art, novelty, freedom-to-operate, or validity search, nor does it constitute legal, financial, investment, or professional advice, and it should not be relied upon as such. Any patent, commercial, or strategic decision should be verified independently and reviewed with qualified patent, legal, and domain professionals. Patsnap makes no warranties, express or implied, as to the accuracy, completeness, or fitness for any particular purpose of the information presented.
Machine translation. Assignee and organisation names originally recorded in Chinese, Japanese or Korean have been rendered into English by an AI translation step so that the tables stay readable. These renderings are best-effort and may not match a company’s registered English name; the original name is what the underlying patent record carries, and it is what any Eureka query launched from this page uses.