Services
Services
Developability Assessment for Biologics & Peptides
Developability Assessment for Biologics & Peptides
Early risk identification to design stable, patient-ready drug products.
Early risk identification to design stable, patient-ready drug products
Why developability matters
Why developability matters
Developability assessment plays a critical role in drug product development. By evaluating a molecule's stability, solubility, manufacturability, and potential liabilities early in the process, teams can prioritize the most promising candidates for success. This upfront clarity reduces the risk of late-stage failure, shortens timelines, and helps design a formulation strategy that supports both clinical and commercial goals.
Understanding your molecule's developability profile early means fewer surprises downstream and allows you to make informed decisions about which candidates deserve further investment and which formulation approaches are most likely to succeed. This strategic advantage becomes even more valuable when working with complex biologics that don't fit standard platform approaches.
Developability assessment plays a critical role in drug product development. By evaluating a molecule's stability, solubility, manufacturability, and potential liabilities early in the process, teams can prioritize the most promising candidates for success. This upfront clarity reduces the risk of late-stage failure, shortens timelines, and helps design a formulation strategy that supports both clinical and commercial goals.
Understanding your molecule's developability profile early means fewer surprises downstream and allows you to make informed decisions about which candidates deserve further investment and which formulation approaches are most likely to succeed. This strategic advantage becomes even more valuable when working with complex biologics that don't fit standard platform approaches.
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
Let’s Build the Right Formulation — Together
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
What you get
Our integrated developability assessment delivers comprehensive insights that directly inform your development decisions and experimental design:
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:
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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.
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
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How it works - integrated methodology
In-silico risk prediction - We identify hotspots for aggregation, deamidation, isomerization, and oxidation using structural models, protein sequence analysis, and machine learning-based tools before you commit precious material to experiments. This computational approach provides early insights into potential stability liabilities and guides experimental design for maximum efficiency.
Related capability: Molecular Modelling
Molecular descriptors & classification - We evaluate parameters like surface hydrophobicity, charge distribution, and predicted viscosity to categorize molecule types and risk classes, providing early insights into manufacturability challenges and formulation requirements. This classification helps predict fill-finish feasibility and guides excipient selection strategies.
Related capability: mAb Modeling and Benchmarking
Stability-related stress testing - Preliminary degradation studies reveal chemical and physical instabilities under stress conditions including pH variations, light exposure, temperature changes, and mechanical agitation. These targeted studies validate computational predictions and provide experimental evidence for formulation optimization.
Explore: Stability studies, Forced Degradation studies and Particle Characterization
Tailored Output for Formulation Strategy - We provide integrated reports with risk scoring, molecule categorization, and tailored formulation hypotheses to guide development decisions.
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
Our Formulation Strategy
Who its ideal for?
Who its ideal for?
This service is especially valuable for teams working with proteins and peptides who need early identification of formulation risks and tailored data and excipient choice. Our systematic approach serves as a modular entry point into comprehensive formulation programs while providing immediate value for development decision-making. It applies across monoclonal antibodies, fusion proteins, enzymes, and therapeutic peptides, with expertise extending to complex biologics including bispecific antibodies, antibody-drug conjugates, and engineered protein formats that require specialized formulation approaches. Whether you're in lead optimization, candidate selection, preparing for clinical development, or addressing specific delivery challenges like subcutaneous administration, our assessment provides the scientific foundation for confident formulation decisions and efficient experimental design.
Why partner with Leukocare?
Leukocare integrates structural biology, data science, and formulation expertise to deliver meaningful developability insights that go far beyond standard screening approaches. Using a sophisticated combination of computational and experimental methods, we uncover potential red flags and translate them into actionable formulation or process decisions tailored specifically to your molecule and aligned with your clinical and manufacturing goals.
Our interdisciplinary approach means you receive much more than isolated data points. You get a coherent, scientifically rigorous story about your molecule's behavior, complete with prioritized recommendations, clear next steps, and seamless integration pathways for moving from assessment to action. This integrated perspective helps accelerate your development timeline while reducing risk and material consumption.
Beyond the assessment itself, our connected service portfolio ensures continuity throughout your development journey, from early risk identification through formulation optimization, stability testing, and manufacturing readiness.
See: Formulation Development
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 &
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.
Proof and Resources
Explore our developability expertise through our webinars
New Publication
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Read it now!
New Webinar
Smart Drug Product Development: Rational formulation designs for highly concentrated biologics
Wednesday, June 25, 2025 · 4:00 p.m. Amsterdam (GMT +2:00)
New Publication
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Read it now!
Latest News
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
Jun 30, 2025
Identification of relevant analytical methods for adeno-associated virus stability assessment during formulation development
Formulation of adeno-associated viral (AAV) vectors requires analytical methods that are predictive of stability, use minimal material, and allow high-throughput testing—criteria that are often difficult to meet. This exploratory study assessed several analytical techniques for their ability to predict or indicate AAV stability. Two methods emerged as particularly promising: extrinsic differential scanning fluorimetry with SYBR Gold for genome release detection, and nano differential scanning fluorimetry for capsid stability. Size-exclusion chromatography with multi-angle light scattering and UV was also effective for monitoring particle size and genome load.
May 30, 2023
An exploratory study on the effect of mechanical stress on particle formation in monoclonal antibody infusions
Monoclonal antibody infusions face risks of particle formation from transport stress, especially at low concentrations. Studies show pembrolizumab and bevacizumab are most affected, highlighting the need to minimize storage time, vibration, and syringe particle entry.
Oct 12, 2022
Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
JHEP Reports. 2023 Feb; 5(2): 100603
SACHERL J. ET AL: Efficient stabilization of therapeutic hepatitis B vaccine components by amino-acid formulation maintains its potential to break immune tolerance
Nov 9, 2018
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
Rentschler Biopharma SE / LEUKOCARE AG/ Informa Pharma Intelligence
"2018 Survey- Formulation in the Drug Product Development Process": 2018 Survey ‘Formulation in the Drug Product Development Process’, based on research from Informa Pharma Intelligence
Apr 20, 2010
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?
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?
