Services

Developability Assessment for Biologics & Peptides

Detect risks early. Build stable, manufacturable, patient-ready drug products with confidence.

From AI-guided excipient prediction over formulation development to predictive stability modeling, we turn antibodies, viruses and viral vectors and other complex ATMPs into stable products. Please also change this in Michael´s quote on our mission on that website

Why developability matters

Developability assessment is where high-value CMC decisions begin. By examining a molecule’s intrinsic risk profile and translating findings into clear formulation and process guidance, we help teams prioritize the right candidates, avoid costly dead ends, and enter subsequent studies with sharper hypotheses. At LEUKOCARE, structural biology, data science and formulation expertise converge to give you an integrated readout—science-first, decision-ready, and aligned with clinical, manufacturing and route-of-administration goals.

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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

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

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

What you get

Our approach provides a consolidated readout that is practical, actionable and designed to accelerate decision-making. Instead of generic risk notes, you receive outputs that can directly inform experimental design, development priorities and clinical planning:

Our approach provides a consolidated readout that is practical,
actionable and designed to accelerate decision-making.
Instead of generic risk notes, you receive outputs that can directly inform
experimental design, development priorities and clinical planning:

Risk score & liability map

Summarizing chemical and physical instabilities such as aggregation, deamidation, isomerization, oxidation and fragmentation.

Risk score & liability map

Summarizing chemical and physical instabilities such as aggregation, deamidation, isomerization, oxidation and fragmentation.

Risk score & liability map

Summarizing chemical and physical instabilities such as aggregation, deamidation, isomerization, oxidation and fragmentation.

DoE-ready formulation hypotheses

Focusing experimental resources on the most promising excipients, buffer systems and pH/ionic strength windows.

DoE-ready formulation hypotheses

Focusing experimental resources on the most promising excipients, buffer systems and pH/ionic strength windows.

DoE-ready formulation hypotheses

Focusing experimental resources on the most promising excipients, buffer systems and pH/ionic strength windows.

Administrability readout

Viscosity, osmolality and syringeability parameters, with direct implications for subcutaneous delivery and device compatibility.

Administrability readout

Viscosity, osmolality and syringeability parameters, with direct implications for subcutaneous delivery and device compatibility.

Administrability readout

Viscosity, osmolality and syringeability parameters, with direct implications for subcutaneous delivery and device compatibility.

Next-step guidance

Linking seamlessly into formulation optimization, stability testing and broader drug product development services.

Next-step guidance

Linking seamlessly into formulation optimization, stability testing and broader drug product development services.

Next-step guidance

Linking seamlessly into formulation optimization, stability testing and broader drug product development services.

See our services

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

How it works - integrated methodology

In-silico risk prediction - We start with structure and sequence-based modeling supported by machine learning identify aggregation-prone regions and chemically labile motifs before material is consumed. These predictions sharpen focus for subsequent work and can even guide sequence engineering.

Related capability: Data Science Services

Molecular descriptors & classification - We calculate descriptors such as hydrophobicity, charge distribution and predicted viscosity/osmolality to categorize molecules into developability classes. This gives an early view on fill-finish feasibility, stability challenges and manufacturability.

Related capability: Drug Substance Characterization

Stability-related stress testing - Targeted stress studies under pH, light, temperature and agitation reveal degradation pathways and validate in-silico hypotheses. This ensures that recommendations rest on real-world data and not just predictions.

Explore: Stability Studies, Forced Degradation Studies, Particle Characterization

Manufacturability & administrability - We analyze adsorption, pH-jump effects, high-concentration viscosity and container-closure interactions to ensure that what looks feasible in silico also works in practice. This step bridges stability with usability.

Related service: Primary Packaging Assessment

Who its ideal for?

This service is especially valuable for teams in lead triage and pre-formulation phases who need to make confident decisions quickly. It applies across monoclonal antibodies, fusion proteins, enzymes and therapeutic peptides as well as other protein modalities. Whether you are comparing multiple candidates, exploring subcutaneous delivery or preparing a CMC strategy for partners and regulators, our assessment provides the data and hypotheses you need.

Why partner with Leukocare?

We provide actionable outputs, not just observations. Our team integrates structural biology, data science and formulation development to deliver a single coherent story—risk scores, liabilities and hypotheses that directly inform design of experiments and decision points. Beyond assessment, we offer connected services so your program can move seamlessly into optimization, extended stability packages and small-scale non-GMP manufacturing without losing momentum.

See: Non-GMP Processing & Small-Scale Manufacturing

We provide actionable outputs, not just

observations. Our team integrates

structural biology, data science

and formulation development to deliver a single coherent story—risk scores, liabilities and

hypotheses that directly inform design of

experiments and decision points. Beyond

assessment, we offer connected services

so your program can move seamlessly into

optimization, extended stability packages

and small-scale non-GMP manufacturing

without losing momentum.

See: Non-GMP Processing &

Small-Scale Manufacturing

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

If you want to see how we approach complex biologics, explore our webinars:

Watch on Demand

Services

Services

Developability Assessment for Biologics & Peptides

Developability Assessment for Biologics & Peptides

Detect risks early. Build stable, manufacturable, patient-ready drug products with confidence.

Why developability matters

Why developability matters

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

What you get

Our approach provides a consolidated readout that is practical, actionable and designed to accelerate decision-making. Instead of generic risk notes, you receive outputs that can directly inform experimental design, development priorities and clinical planning:

Our approach provides a consolidated readout that is practical, actionable and designed to accelerate decision-making. Instead of generic risk notes, you receive outputs that can directly inform experimental design, development priorities and clinical planning:

Risk score & liability map

Risk score & liability map

Risk score & liability map

DoE-ready formulation hypotheses

DoE-ready formulation hypotheses

DoE-ready formulation hypotheses

Administrability readout

Administrability readout

Administrability readout

Next-step guidance

Next-step guidance

Next-step guidance

See our services

Let’s Build the Right Formulation — Together

Let’s Build the Right Formulation — Together

How it works - integrated methodology

Who its ideal for?

Why partner with Leukocare?

Let’s Build the Right Formulation — Together

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

Let’s Build the Right Formulation — Together

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

If you want to see how we approach complex biologics, explore our webinars:

FAQ

Which molecule classes do you work with most often?

What is SMART Formulation® and how does it differ from classic screening?

How long does a typical formulation project take?

Can you supply non-GMP material for pre-clinical studies?

FAQ

Which molecule classes do you work with most often?

What is SMART Formulation® and how does it differ from classic screening?

How long does a typical formulation project take?

Can you supply non-GMP material for pre-clinical studies?

Our approach provides a consolidated readout that is practical,
actionable and designed to accelerate decision-making.
Instead of generic risk notes, you receive outputs that can directly inform
experimental design, development priorities and clinical planning: