Leukocare Logo

Drug Product Formulation For Liquids and Lyophilized Products

Solve formulation challenges in Your Biologic Drug Development

Overcome stability and aggregation challenges with data-driven formulation strategies

20+ Years experience
400+ Successful projects
98% Client satisfaction

Common challenges

Struggling with Formulation Challenges?

Stability-3

Poor Stability

Unstable formulations under required storage conditions delay timelines and threaten approval.

Insufficient Data-2

Insufficient Data

Missing stability or characterization data creates regulatory gaps that halt submissions.

Complex Requirements-2

Complex Requirements

ATMP and biologic formulation demands specialized expertise most CMOs simply don't have.

Success story

How We Transformed a Biologic Product

Challenge

Unstable formulation, limited shelf life at 2–8 °C

 

Our solution

Data-driven formulation optimization strategy

 

The result

Commercially viable product profile achieved

 

Outcome

Shelf life extension achieved

 

+20 months

 

From unstable to commercially viable — enabling regulatory submission and market readiness.

Why Leukocare

Trusted Formulation Expertise
for Biologics & ATMPs

20+

Years of experience

Supporting biologics formulation programs since 2002, across various modalities.

400+

Successful projects

A deep track record across IND-ready, optimization, and stability programs.

98%

Client satisfaction

Clients who work with us return and refer others in their network.

 

State-of-the-art labs

Advanced analytical and formulation infrastructure built for complex biologics.

 
"

Our company had to deal with an unstable protein formulation, and Leukocare supported us with multiple rounds of formulation screening to find an improved formulation candidate. We appreciate the broad analytical capabilities, clear communication and timely delivery of results in clear reports.

 
Merus Logo
 

Merus N.V.

Verified client

Success story

From Stability Challenge to
Commercially Viable Formulation

A biologic candidate with limited stability at 2–8°C required a more robust formulation strategy to support development goals. Using Leukocare's data-driven approach, the program moved toward a commercially viable product profile with improved stability potential.

Challenge

  • Unstable Formulation at 2–8°
  • Significant Aggregation Risk
 

Approach

  • Data-driven formulation optimization
  • Targeted stability strategy based on molecular insights
  • Systematic identification of critical stability drivers
 

Outcome

  • +20 month shelf life extension
  • Reduced aggregation risk
  • Improved stability under real storage conditions
 
 

Result

Shelf life extended by over 20 months — enabling regulatory submission and market readiness.

Success story

From Stability Challenge to
Commercially Viable Formulation

A biologic candidate with limited stability at 2–8°C required a more robust formulation strategy. Using Leukocare's data-driven approach, the program moved toward a commercially viable product profile.

Challenge

  • Unstable Formulation at 2–8°
  • Significant Aggregation Risk
 

Approach

  • Data-driven formulation optimization
  • Targeted stability strategy based on molecular insights
  • Systematic identification of critical stability drivers
 

Outcome

  • +20 month shelf life extension
  • Reduced aggregation risk
  • Improved stability under real storage conditions
 

Shelf life extended by over 20 months — enabling regulatory submission and market readiness.

Take the next step

Ready to Optimize Your
Drug Formulation?

Get in touch with our formulation experts today. We'll review your challenge and respond shortly.

 
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"

Working with Leukocare has been an exceptional experience. Their flexibility responding to our changing priorities and timelines has been instrumental in meeting our program goals. They truly operate as an extension of our internal team — collaborative, responsive, and fully aligned with our program objectives.

What stands out is their scientific approach which revolves around thoughtful experimental design and the collection of robust data. Leukocare consistently delivered high-quality data and important insights that supported critical decision-making. Their combination of speed, scientific excellence, and teamwork makes them a trusted and valued partner on our development journey.

 
Elion Therapeutics Inc.-1
 

Elion Therapeutics Inc.

Verified client