Services
Services
Pre-Formulation Studies for Biologics
Pre-Formulation Studies for Biologics
Build a solid foundation with scientifically sound pre-formulation insights.
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 pre-formulation matters
Why pre-formulation matters
Preformulation studies are the foundation of successful drug product development, providing essential understanding of the physical, chemical, and biological characteristics of a molecule that enables formulation scientists to make informed decisions about excipient selection, dosage form design, and process development strategies. Poor solubility, chemical instability, or physical degradation are among the common pitfalls that can be identified and addressed early through systematic pre-formulation work.
Without proper pre-formulation, development teams often encounter unexpected stability issues, manufacturing problems, or formulation failures late in development when they are most expensive to address and can significantly delay program timelines. A thorough pre-formulation program provides the scientific foundation needed to avoid these costly setbacks while establishing the knowledge base for all subsequent development activities.
Preformulation studies are the foundation of successful drug product development, providing essential understanding of the physical, chemical, and biological characteristics of a molecule that enables formulation scientists to make informed decisions about excipient selection, dosage form design, and process development strategies. Poor solubility, chemical instability, or physical degradation are among the common pitfalls that can be identified and addressed early through systematic pre-formulation work.
Without proper pre-formulation, development teams often encounter unexpected stability issues, manufacturing problems, or formulation failures late in development when they are most expensive to address and can significantly delay program timelines. A thorough pre-formulation program provides the scientific foundation needed to avoid these costly setbacks while establishing the knowledge base for all subsequent development activities.
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
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.
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 pre-formulation studies provide comprehensive characterization and scientific foundation that directly informs all subsequent formulation and process development activities:
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
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:
text for spacing
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.
text for spacing
How it works - integrated methodology
Analytical Method Development - We establish reliable, fit-for-purpose analytical tools to support your entire development program, focusing on stability-indicating methods that can detect and quantify relevant degradation products, potency assays optimized for your specific molecule and intended use, and physical characterization methods for aggregation, particulates, and other critical quality attributes
Related capability: Particle Characterization
Drug Substance Characterization - Our systematic modeling approach evaluates risks for critical quality attributes such as aggregation, deamidation, oxidation, and solubility through advanced computational methods including surface hydrophobicity mapping, charge distribution analysis, and molecular interaction predictions.
Related capability: Forced Degradation Studies
Identification of Critical Challenges - We systematically identify and characterize key challenges by in-silico modeling and lab based characterization to impact formulation success including instability mechanisms such as aggregation, fragmentation, chemical degradation, solubility limitations, concentration-dependent behavior, containers or processing conditions, and manufacturing sensitivities that could impact process robustness.
Explore: Molecular Modeling
Dosage from Design - Our pre-formulation work directly informs dosage form selection and design through liquid formulation feasibility assessment including high-concentration and subcutaneous delivery requirements, lyophilization compatibility assessment including excipient interactions and cake quality, and alternative format evaluation for specialized delivery requirements or stability challenges
Related service: Primary Packaging Assessment
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
Rational Excipient Selection - Our sophisticated predictive models suggest optimal excipient combinations based on molecular structure and formulation context. These models are continuously refined with new experimental data and successful formulation outcomes to improve accuracy and reliability over time.
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 it`s ideal for?
This service is especially valuable for teams working with small molecules, biologics, or complex drug substances who need parenteral drug product development for systematic characterization and risk reduction through insight-driven assessments that establish the scientific foundation for all subsequent development activities.
It applies across all therapeutic modalities requiring solid scientific foundation for downstream formulation and process development activities, with particular expertise in complex biologics, protein therapeutics, and challenging molecular formats that require specialized analytical and characterization approaches.
Whether you're identifying molecular incompatibilities early in development, predicting potential stability issues, supporting rational excipient selection, or developing formulation hypotheses for experimental validation, our modeling provides the computational foundation for targeted, efficient development approaches.
Why partner with Leukocare?
At Leukocare, preformulation goes far beyond a standard checklist approach. We treat it as a science-driven, data-informed process that guides all downstream formulation and process development activities with systematic rigor and deep analytical expertise. Whether you are working with small molecules, biologics, or complex drug substances, our structured studies ensure that your development pathway is built on solid scientific ground with comprehensive understanding of molecular behavior.
We combine analytical depth with a Quality by Design mindset to systematically characterize drug substances, define optimal formulation strategies, and reduce development risk while conserving valuable drug substance material through efficient experimental design.
Our preformulation programs are specifically designed to generate maximum insight while minimizing material consumption through strategic study design and statistical approaches. Our preformulation studies are designed to de-risk development, save valuable drug substance material, and shorten time-to-formulation through insight-driven assessments that provide actionable recommendations for all subsequent development activities.
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
We model monoclonal antibodies, bispecific formats, antibody-drug conjugates, fusion proteins, enzymes, therapeutic peptides, and other engineered biologics, with specialized capabilities for complex conjugates and novel protein architectures.
Let’s Build the Right Formulation — Together
We model monoclonal antibodies, bispecific formats, antibody-drug conjugates, fusion proteins, enzymes, therapeutic peptides, and other engineered biologics, with specialized capabilities for complex conjugates and novel protein architectures.
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)
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.
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.
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.
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?