Services
Services
Formulation Development and Optimization
Formulation Development and Optimization
Transform your molecule into a great drug product.
Transform your molecule into a great drug product
Formulation development bridges the gap between a promising molecule and a viable drug product, ensuring stability, usability, manufacturability, and compatibility with delivery systems while meeting the specific requirements of your target patient population. Formulation is rarely a one-size-fits-all solution and must evolve with your development stage while reflecting the unique characteristics of your specific molecule and its intended clinical application.
Frozen formulations may be suitable for Phase I studies, while later stages demand user-friendly products. Many complex biologics do not fit into platform approaches and instead require tailored design based on molecular behavior and specific stability profiles.
Formulation also serves as a strategic lever for competitive advantage. A well-designed formulation can de-risk development by improving product robustness, shorten timelines by reducing trial-and-error approaches, enable differentiated dosing regimens or delivery routes, and create intellectual property opportunities for long-term commercial success and market differentiation
Explore our drug product development services
Formulation development bridges the gap between a promising molecule and a viable drug product, ensuring stability, usability, manufacturability, and compatibility with delivery systems while meeting the specific requirements of your target patient population. Formulation is rarely a one-size-fits-all solution and must evolve with your development stage while reflecting the unique characteristics of your specific molecule and its intended clinical application.
Frozen formulations may be suitable for Phase I studies, while later stages demand user-friendly products. Many complex biologics do not fit into platform approaches and instead require tailored design based on molecular behavior and specific stability profiles.
Formulation also serves as a strategic lever for competitive advantage. A well-designed formulation can de-risk development by improving product robustness, shorten timelines by reducing trial-and-error approaches, enable differentiated dosing regimens or delivery routes, and create intellectual property opportunities for long-term commercial success and market differentiation
Explore our drug product development services
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
Why formulation development matters
What you get
Our systematic formulation development delivers optimized drug products that meet your clinical and commercial requirements while ensuring manufacturing feasibility and regulatory compliance:
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.
text for spacing
How it works - integrated methodology
How it works - integrated methodology
Integration of Modeling and Pre-formulation Insights - We seamlessly integrate computational predictions and preformulation findings to create targeted formulation designs, focusing experimental efforts on the most promising formulation space rather than conducting broad, unfocused screening studies that consume valuable material without clear direction.
Related capability: Molecular Modeling
Development of Tailored Formulations -Our team develops optimized formulations for both liquid and lyophilized injectable products, with deep understanding of the unique requirements and challenges associated with each format. We can adapt formulation strategies as your program evolves from early-phase to commercial requirements.
Related capability: Process Development
Optimization for Subcutaneous, Intravenous, or Other Parenteral Routes - We optimize formulations for specific administration routes including subcutaneous delivery with attention to injection volume, viscosity, and patient comfort, intravenous administration focusing on compatibility with diluents and infusion systems, intramuscular injection considering depot formation and local tolerance, and other parenteral routes as required by your therapeutic approach.
Explore: High Concentration Antibody and High Concentration Subcutaneous Biologics
Evaluation of High-Concentration Feasibility - For products requiring high-concentration formulations, we systematically evaluate feasibility and develop strategies to overcome common challenges such as viscosity management through excipient selection and formulation optimization, protein-protein interactions that can lead to aggregation or precipitation, manufacturing challenges related to mixing, filtration, and filling operations, and device compatibility for self-administration systems.
Related service: HighCon
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
Execution of Accelerated and Long-Term Stability Testing - We execute comprehensive stability testing programs following ICH guidelines including accelerated stability studies to support formulation selection and optimization, long-term stability monitoring to establish shelf-life and storage conditions, stress testing to understand formulation robustness and identify potential failure modes, and in-use stability to support clinical administration and patient use scenarios.
Explore: Stability Studies
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
Generation of Data Packages - We generate complete data packages and documentation to support regulatory submissions and technology transfer including CMC documentation suitable for regulatory submissions, justification for formulation choices and manufacturing processes, stability data formatted according to ICH guidelines, and risk assessments and control strategies aligned with regulatory expectations.
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 developing complex biologics that require tailored formulation approaches beyond standard platform methods, with expertise spanning challenging therapeutic modalities and specialized delivery requirements that demand sophisticated formulation solutions.
It applies across monoclonal antibodies, peptides, ADCs, viral vectors, vaccines, and small molecules, with specialized expertise in challenging modalities including bispecific antibodies, complex conjugates, gene therapy products, and other advanced therapeutic formats requiring customized development approaches.
Why partner with Leukocare?
Leukocare's formulation development approach combines more than 20 years of hands-on formulation experience with advanced data science capabilities and cutting-edge analytical tools. Each year, we successfully deliver approximately 40 formulation projects across diverse therapeutic modalities including antibodies, peptides, antibody-drug conjugates, viral vectors, vaccines, and small molecules, consistently achieving 98% customer satisfaction through our systematic, science-driven approach.
Our service modules are specifically designed to match your development stage, timeline constraints, and budget requirements while maintaining the highest scientific standards. By applying Quality by Design principles and sophisticated Design of Experiment methodologies, we generate conclusive, actionable results while minimizing material usage and accelerating development timelines.
Combined with our comprehensive analytical and data science support, this approach ensures your formulation is not only stable and scalable but also strategically aligned with your development goals and commercial requirements. We understand that every molecule presents unique challenges, and our team brings deep experience across multiple modalities to adapt our approach to your specific needs.
See: Lyophilization Services Viral Vector Formulation
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.
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 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.
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?