Development & Manufacturing Excellence
Transitioning from Research to Development
Development Services
Process Chemistry Services
Our dedicated process chemistry team is committed to aiding you in route scouting and crafting a process tailored to your project's needs. This process guarantees safety, reproducibility, robustness, and superior quality. All our process development endeavors are guided by Quality by Design (QbD) principles, integrating analytical and risk-management methodologies throughout molecule design, development, and manufacturing stages.
Route Exploration and Process Development
The process begins with designing the route, which involves conducting retrosynthetic analysis, practical evaluation for yield enhancement, and ensuring safety through thorough thermodynamic studies. This leads to route investigation, encompassing in-depth exploration of potential routes and method development. The process is developed, optimizing both early and late-stage processes, employing strategically designed experiments (DoE), and troubleshooting reactions.
Tailored Scale-Up Solutions
Navigating the transition from preclinical to commercial-scale manufacturing brings intricate challenges and intricacies. Our custom scale-up service encompasses in-house production ranging from hundreds of grams to kilograms of non-GMP material, serving demo batches, proof of principle, and preclinical studies. Seamlessly transferring technology to larger scales and ensuring GMP-compliant manufacturing is a pivotal aspect of our offering.
Analytical Solutions
Leveraging a wealth of experience, our analytical specialists expedite the transformation of your molecule from conception to clinical stages and beyond with unwavering success. Complemented by abundant capacity and diverse analytical insight, we provide our clients unparalleled access to a team of genuine problem solvers well-versed in the entire product life cycle. With an arsenal of cutting-edge analytical and synthetic equipment, we excel in conducting meticulous impurity identification for drug substances.
Route Scouting
Pioneering Efficiency Route scouting is foundational in identifying a safe, efficient, and cost-effective synthesis process for large-scale production. Key questions encompass safety considerations, raw material availability and affordability, patent implications, intermediate stability, purification methods, environmental concerns, and alternative routes derived from thorough literature reviews. Regulatory compliance is also weighed, shaping decisions that optimize time, cost, and quality. Our approach integrates these crucial aspects to formulate an optimized route.
Analytical Support
Our integrated analytical support entails method development and synthesizing and purifying analytical standards to empower accurate analysis and quality assessment.
Our proficiency extends across diverse domains, encompassing
- Method development and refinement
- Rigorous method validation
- Thorough explorations of stability and forced degradation
- Comprehensive impurity investigations
- Crafting high-caliber analytical methods that extend the product's lifecycle, augmented by innovative strategies and state-of-the-art instrumentation for unrivaled precision, sensitivity, and robustness.
- Proactively addressing challenges, enhancing existing methodologies, and amplifying their scope.
Get the successful preclinical and clinical development Services
Our Impurity Identification Solutions Encompass
- Harnessing mass spectrometry (MS) and ultra-performance liquid chromatography (UPLC) techniques
- Employing high-resolution mass spectrometry (HRMS) for pinpoint identification and validation of impurity molecular structures through MS/MS experiments
- Strategically isolating impurities through preparative high-performance liquid chromatography (HPLC)
- Leveraging nuclear magnetic resonance (NMR) analysis to elucidate the structure of impurities comprehensively.
