CORUM offer a broad range of pharmaceutical custom development services to support novel drug development, from preclinical through clinical phases to regulatory filing and commercialization.
Depending on the stages of drug development, where timing could be more critical in early stages and cost saving becomes more important in late clinical stages, we develop phase-appropriate processes to address current needs and keep our customers well informed of options that could be available in the future. Despite the different needs at different stages, it is important to take as many factors as possible into consideration at the beginning of the process development. Impact on impurity profile must be controlled and a robust and scalable method is needed to avoid polymorphic transformation during the process. Less toxic and more environmentally friendly organic solvents are selected whenever feasible to ensure patient safety and minimal impact on environment.
Polymorph Study & Single Crystal Growing
A drug substance may exist in polymorphic forms, which could be crystalline, amorphous, solvate and hydrate. Identifying the most suitable form is critical to the stability, dissolution and bioavailability of the drug product. We assist drug developers to identify optimal reaction conditions to grow the target polymorph and minimize the presence of unwanted polymorphs.
Chiral Resolution
Some drugs were developed and marketed as racemates. As technology advances, the regulatory authorities require drug developers to separate stereoisomers and evaluate their efficacies individually. Some stereoisomers exhibit different properties in various aspects such as toxicology and pharmacokinetics (absorption, distribution, mechanism and excretion). Differences in toxicity may result in adverse effects, which pose big challenges to the development of safe and effective drugs. With a proven track record of success, we develop chiral assay to separate and quantify individual stereoisomers so that the pharmacokinetic and toxicity profile of individual stereoisomers can be characterized.
Drug Substance Characterization
A good understanding of the chemical and physical properties of the drug substance is critical to drug formulation development. Characterization data is generated to confirm its structure, purity, crystallinity, hygroscopicity, solubility and stability. Through collaboration with local universities and testing institutes, we provide advanced testing such as differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), X-ray crystallography (XRD), nuclear magnetic resonance spectroscopy (H NMR, C NMR) and particle size distribution analysis (PSD), etc.
Impurities may arise from starting materials, process and degradation. Some of them may be eliminated in the manufacturing process but some may remain in the drug substance and drug product. Their presence and levels must be monitored and quantified throughout the development phases and commercialization. We synthesize active pharmaceutical ingredient (API) and impurity reference standards at laboratory scale and provide characterization reports as well as certificate of analysis.
To ensure quality consistency of drug substances, each batch of the material should be tested and released with validated analytical methods, as early as in preclinical phases. We develop stability indicating methods, with forced degradation studies, to determine the purity of the drug substance and monitor the levels and trends of impurities. The residual solvents levels are detected and monitored to ensure compliance.
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