Your Molecule

How We Solve High-Concentration Challenges

Stable, patient-friendly injectable biologics - even above 200 mg/mL. We engineer high-concentration formulations that meet stability, viscosity and usability targets for subcutaneous (SC) delivery.

Early risk identification to design stable, patient-ready drug products

Why high concentration matters

Subcutaneous administration shortens administration time, improves patient convenience and reduces healthcare burden — but it often pushes biologics above 100–200 mg/mL where viscosity, aggregation and processing issues can derail development. Our approach combines targeted experimental design with advanced data science to de-risk these challenges early and chart a clear path to a stable, usable drug product.

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Our approach

We structure each program into focused work-packages that answer the key feasibility and usability questions for SC dosing: excipient strategy, viscosity/injectability behavior, aggregation risks, and the molecule’s practical concentration ceiling. Decisions are underpinned by design-of-experiments (DoE) and predictive models to cut iteration and conserve drug substance.

Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.

Talk to our experts

Let’s Build the Right Formulation — Together

Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.

Talk to our experts

Let’s Build the Right Formulation — Together

Key Focus Areas

Excipient selection for high concentration

Molecular Modeling, Data-guided buffer/surfactant/amino-acid systems;

Excipient selection for high concentration

Molecular Modeling, Data-guided buffer/surfactant/amino-acid systems;

Excipient selection for high concentration

Molecular Modeling, Data-guided buffer/surfactant/amino-acid systems;

Concentration feasibility testing

Establish upper limits: high-concentration stability under stress conditions

Concentration feasibility testing

Establish upper limits: high-concentration stability under stress conditions

Concentration feasibility testing

Establish upper limits: high-concentration stability under stress conditions

Advanced viscosity & injectability profiling

Rheology across concentration and shear; evaluation of viscosity-lowering strategies; correlation of viscosity with stability to avoid trade-offs. Injection-force mapping informs device/needle choices.

Advanced viscosity & injectability profiling

Aggregation risk prediction & mitigation

Identification of high-concentration PPI hot-spots, mitigation via excipients and solution conditions, and forced-degradation insights to maintain clarity and potency.

Aggregation risk prediction & mitigation

Identification of high-concentration PPI hot-spots, mitigation via excipients and solution conditions, and forced-degradation insights to maintain clarity and potency.

Aggregation risk prediction & mitigation

Identification of high-concentration PPI hot-spots, mitigation via excipients and solution conditions, and forced-degradation insights to maintain clarity and potency.

Data science & biostatistics

Early de-risking with relevant models, statistical analysis of non-linear interactions, and real-use shelf-life prediction to support expiry dating with less data.

Data science & biostatistics

Early de-risking with relevant models, statistical analysis of non-linear interactions, and real-use shelf-life prediction to support expiry dating with less data.

Data science & biostatistics

Early de-risking with relevant models, statistical analysis of non-linear interactions, and real-use shelf-life prediction to support expiry dating with less data.

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Let’s Build the Right Formulation — Together

Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.

Talk to our experts

Let’s Build the Right Formulation — Together

Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.

Talk to our experts

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Improved stability at almost 2x the antibody concentration

Case Study

We have optimized antibody formulations above 200 mg/mL for pre-filled syringe use, meeting stability, viscosity and usability criteria through advanced excipient systems and process .

Up-concentrating and antibody using a standard formulation does not always result in a stable drug product. The up-concentrated commercially available formulation (red) is significantly less stable as it results in a drastically increased rate of aggregation. In comparison, Leukocare's HighCon antibody formulation (blue) achieved a 2-fold higher concentration while stably preventing any increase in aggregate formation over time.