We’re bringing a data-driven mindset to formulation science by combining deep biologics expertise with advanced data science. This allows for de-risking and accelerating the development of robust, scalable drug products.
Michael Scholl
CEO
Leukocare was founded in 2003 by Prof. Martin Scholz and Michael Scholl, with an initial focus on stabilizing biomolecules for functionalization of medical devices. This pioneering work in protein stabilization laid the foundation for our expertise in drug product formulation.
We have evolved into a trusted partner for biotech, mid-size pharmaceutical companies, and leading global players, who turn to us for our deep modality experience and our rigorous data-driven formulation strategies. Our portfolio spans monoclonal and bispecific antibodies, viral vectors for gene therapy, vaccines, and other complex biologics.
To strengthen our scientific foundation, we established dedicated teams in bioinformatics and biostatistics, enabling us to integrate molecular modeling, predictive analytics, and statistical design of experiments into every stage of formulation development.
Today, stability remains in our DNA as we continue our journey as a fully integrated service provider for complex drug product development — combining scientific rigor with proven industry trust.
Executive Team: Steering vision, strategy and day-to-day execution.
Seasoned life-science entrepreneurs and biopharma leaders who chart Leukocare’s strategy, culture, and operational excellence.
Supervisory Board: Independent governance and strategic guidance.
Independent industry veterans and investment leaders providing governance, capital-market insight, and long-term strategic direction.
Scientific Advisory Board: World-class scientists who keep our innovation edge sharp.
Globally renowned scientists who channel the latest academic breakthroughs into our formulation technologies and R&D pipeline.
Robust Analytical Foundations
Scientifically sound, fit for purpose analytical methods are the foundation of successful formulation development.
Methods are selected based on product specific prior knowledge and the critical quality attributes to be addressed.
Depending on project needs, methods range from verified assays (including stability indicating properties and autosampler stability) to custom-developed methods fully qualified under ICH Q2 standards.
Risk assessments and mitigation strategies are continuously applied to anticipate and control potential challenges.
A Quality System Built for Reliability
Our QMS is uniquely comprehensive for a development focused company. It includes:
Standardized operating procedures (SOPs) for all equipment and methods
Rigorous training protocols to ensure consistency
Exclusive use of calibrated and maintained equipment
Comprehensive planning and reporting processes
Full traceability of materials, methods, and equipment
Annual internal audits and strict handling of deviations with corrective and preventive actions (CAPAs) .
Supplier qualification and auditing, along with controlled inventory and logistics processes
Data Integrity by Design
To further strengthen reliability, our automated data pipelines connect data generation, migration, evaluation, visualization, and storage.
This minimizes manual intervention, ensuring consistency and integrity.
All codes are developed in‑house and remain fully accessible, reinforcing transparency and accountability.
