More than 20 years of experience
Broad analytical toolbox
Molecular Modeling
The Cornerstone of Drug Development: Drug Substance Characterization
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 Drug Substance Characterization Expertise
Leukocare’s Expertise in Drug Substance Characterization
With more than two decades of experience, Leukocare has established itself as a trusted leader in Drug Substance (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.
Key Aspects of DS Characterization:
Assessing Purity, Potency, and Stability: We dive deep into the essential traits of your DS, ensuring it meets the highest quality standards. Purity, potency, and stability assessments are the cornerstones of a strong drug foundation.
Identifying Potential Liabilities: Our experts are trained to spot potential pitfalls that could lurk downstream in processing and formulation development. We enhance this analysis using data-science techniques such as Molecular Modeling for in-silico anaylsis. By addressing liabilities early, we prevent issues from derailing your progress.
Impurity and Contaminant Analysis: Beyond the obvious, we meticulously identify and quantify impurities or contaminants that may compromise your product's integrity.
Optimizing Drug Development Strategy: DS characterization isn't just about data; it's about strategy. We work with you to fine-tune your development plan, ensuring it's as efficient and effective as possible.
Biophysical Characterization
Conformational Stability
Colloidal Stability
Temperature-induced protein unfolding and aggregation
Molecule-Molecule interactions
Size Distribution
Thermodynamic Effects (KD)
Molecular purity and integrity analysis
Molecular Weight Species (LMWS & HMWS)
Basic and Acidic Species
Charged Variants
Molecular Modeling
In-silico analysis of liability sites
