Broad analytical toolbox
Drug Substance (DS) characterization is a pivotal step in the development process. It is not just about guaranteeing safety and efficacy; it’s about minimizing risks and optimizing your time and resources. Effective DS characterization extends beyond the lab – it serves as your guide for identifying the most promising lead candidate and establishing a clear path toward successful development.
Leukocare’s Expertise in Drug Substance Characterization
With more than two decades of experience, Leukocare has established itself as a trusted leader in DS characterization. Our unwavering dedication to excellence and innovation is evident in every aspect of our work, offering you a solid foundation for a successful drug development journey.
Stability Assessment Experts
With years of experience, we have honed our expertise in analyzing the stability of DS using a comprehensive range of biophysical, physio-chemical, and chemical assessments. Our rigorous methods provide you with a complete picture of your DS's stability profile.
Identifying Potential Liabilities
Leukocare doesn't just rely on traditional methods; we leverage cutting-edge in-silico analysis to identify potential DS liabilities. This forward-thinking approach helps you address issues early in the development process, minimizing risks and ensuring smoother downstream processing.
The Power of Data Science
We combine wet-lab experiments with state-of-the-art data science techniques to unravel complex correlations within your DS. This synergy allows us to offer you a more comprehensive understanding, empowering you to make informed decisions.
Optimal Candidate Selection
Armed with evidence-based knowledge, our team assists you in selecting the most promising lead candidates. This strategic decision-making minimizes the chances of downstream processing (DSP) and formulation issues such as aggregation or instabilities.
Ensuring Efficacy, Quality, and Stability
Our unwavering dedication significantly increases the likelihood of ensuring efficacy, quality, and stability in your DS which is the foundation of clinical and commercial success.
At Leukocare, we don't just provide services; we partner with you on your journey to develop safe and effective drug products. Discover the Leukocare advantage today and let us help you achieve your drug development goals with precision and confidence.
Drug Substance Characterization
- Conformational stability
- Colloidal stability
- Temperature-induced protein unfolding and aggregation
- Molecule-molecule interactions
- Size distribution
- Thermodynamic effects (KD)
- Molecular weight species (LMWS & HMWS)
- Chemical modifications
- In-silico analysis of liability sites