R&D
R&D Procedure of Drug Screening
At NutrigeneAI Biotech Limited, our drug screening process involves several meticulous steps to ensure the identification and validation of effective and safe drug candidates. Our approach leverages the latest advancements in induced pluripotent stem cell (iPSC) technology, high-throughput screening, and data analytics to streamline the drug discovery process.
1. iPSC Generation and Differentiation
Cell Reprogramming:
• Adult cells (e.g., skin or blood cells) are reprogrammed into iPSCs using defined factors. This process involves introducing specific genes (often through viral vectors) that reset the cells to an embryonic-like pluripotent state.
Differentiation into Target Cell Types:
• iPSCs are differentiated into specific cell types relevant to the disease or drug target, such as cardiomyocytes, neurons, hepatocytes, or endothelial cells. This is achieved through the application of specialized growth factors and signaling molecules that guide the cells’ development.
2. Disease Modeling
Establishing Disease-Specific Cell Models:
• iPSCs derived from patients with specific genetic conditions are used to create disease-specific models. These models replicate the cellular and molecular characteristics of the disease, providing a relevant system for studying disease mechanisms and drug responses.
Functional Characterization:
• The differentiated cells are thoroughly characterized to ensure they exhibit the expected phenotypic and functional properties. This involves assays to confirm cell identity, functionality, and the presence of disease-specific markers.
3. Assay Development
Designing High-Throughput Assays:
• High-throughput screening assays are developed to evaluate the effects of large libraries of compounds on the iPSC-derived cells. These assays are designed to measure key parameters such as cell viability, proliferation, differentiation, and specific cellular functions.
Automation and Miniaturization:
• Assays are optimized for automation and miniaturization to increase throughput and reduce reagent costs. Robotic systems and microplate formats are used to handle large numbers of samples efficiently.
4. High-Throughput Screening
Compound Library Screening:
• Large libraries of chemical compounds, including approved drugs, natural products, and novel chemical entities, are screened against the iPSC-derived cell models. Each compound is tested for its ability to modulate the disease phenotype or target-specific cellular processes.
Data Collection and Analysis:
• Automated imaging systems and other detection technologies are used to collect data on the cellular responses to each compound. Data is analyzed using advanced software tools to identify hits—compounds that show desirable effects on the cells.
5. Hit Validation and Optimization
Secondary Screening:
• Initial hits identified in the high-throughput screen undergo secondary screening to confirm their activity and eliminate false positives. This involves more detailed assays and additional cell types to ensure specificity and efficacy.
Lead Optimization:
• Validated hits are further optimized to improve their potency, selectivity, and pharmacokinetic properties. Medicinal chemistry approaches are used to modify the chemical structure of the hits and enhance their drug-like characteristics.
6. Mechanistic Studies
Target Identification:
• Studies are conducted to identify the molecular targets and pathways affected by the lead compounds. This may involve techniques such as proteomics, genomics, and bioinformatics to elucidate the mechanism of action.
Pathway Analysis:
• Detailed analysis of the cellular pathways modulated by the compounds helps to understand their therapeutic potential and predict possible side effects.
7. Preclinical Testing
In Vitro Toxicity and Efficacy Testing:
• Comprehensive in vitro testing is performed to assess the toxicity and efficacy of the lead compounds. This includes tests on multiple cell types and disease models to ensure broad applicability and safety.
In Vivo Studies:
• Promising compounds are tested in animal models to evaluate their pharmacokinetics, bioavailability, and in vivo efficacy. These studies provide critical data on the potential therapeutic benefits and risks of the compounds.
8. Regulatory Compliance and Documentation
Regulatory Submissions:
• Detailed documentation of the screening process, assay development, and preclinical testing is prepared to support regulatory submissions. This includes data on compound safety, efficacy, and manufacturing processes.
Good Laboratory Practice (GLP) Standards:
• All research activities are conducted in compliance with GLP standards to ensure data integrity, reproducibility, and regulatory acceptance.
Conclusion
Our comprehensive R&D procedure for drug screening with iPSC-derived cells integrates advanced cellular technologies, high-throughput screening, and rigorous validation to accelerate the discovery of safe and effective therapeutics. By leveraging the potential of iPSCs, we provide a more human-relevant and predictive platform for drug discovery, ultimately improving the chances of clinical success.