More than 20 years of experience
Over 150 projects
98% customer satisfaction
The Strategic Advantage of Smart Drug Formulation
A proper formulation de-risks the clinical development of your drug substance (DS). SMART Formulation development can increase the stability of your DS and help you to bring your drug product to the clinic fast. With additional development packages SMART Formulation can strongly increase the stability of your DS, improve the route of administration, the dosing regimen, and logistics to gain competitive advantage. Even the option to create a new foreground IP and achieve longer commercial success can be achieved with an advanced formulation. Leukocare is a leading pioneer with a superior formulation approach combining expertise and data science.
Leukocare's Advanced Formulation Approach
Leukocare’s advanced formulation development of drug products is based on decades of formulation expertise and state-of-the-art Data Science. We offer flexible service modules that fit to your development stage, needs, timelines, and budget. This includes an expansive portfolio of analytical and data science services. We use state-of-the-art Design of Experiment (DoE) and work follows the Quality by Design (QbD) principles. Of course, we have customer-centric project management for every project.
"Leukocare's scientific expertise can help to de-risk your drug development."
Case Study
Viral stability of Ad5 maintained more than 24 months at 5° C during liquid storage
The Leukocare formulations (blue lines) of Human species C adenovirus serotype 5 (Ad5) maintained viral stability and infectivity during liquid storage for at least 24 months at 5° C.
Reinauer et al. (2020), J Pharm Sci
Case Study
Improved stability at almost 2x the antibody concentration
Up-concentrating an antibody using a standard formulation does not always result in a stable drug product. The up-concentrated commercially available formulation (red) is significantly less stable as it results in a drastically increased rate of aggregation. In comparison, Leukocare’s HighCon antibody formulation (blue) achieved a 2-fold higher concentration while stably preventing any increase in aggregate formation over time.
Kemter et al. (2018), Biotechnol
Formats
Liquid
Liquid-frozen
Freeze-dried
Spray-dried
Specialized for different routes of administration
High Concentrations
Methodologies
Biophysical Characterization
Forced Degradation Studies
Molecular Modeling
Stability-indicating Analytical methods for several modalities
Robustness Studies
Development of Final Formulation Process
Biostatistics
Data science based excipient selection
DoE for full design space exploitation
Shelf-life Prediction
