ROYESH-SCB R&D Approach
ROYESH-SCB Institute always strives to create its R&D approach comprehensive, interdisciplinary, and aligned with the best methods and international guidelines. Below is an outlined strategy, reflecting our insight.
1. Fundamental & Applied Research Themes
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Fundamental Biotechnology
Investigating self-renewal, pluripotency, differentiation, and the molecular mechanisms underlying stem cell states (e.g., pluripotent, adult, disease-associated stem cells).
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Disease Modeling
Using induced pluripotent stem cells (iPSCs) and organoids to create in vitro models for genetic diseases, malignancy, and regenerative failure.
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Therapeutic Development
Translating research into clinical-grade cell therapies, prioritizing safety, efficacy, and scalability. Develop cell and gene therapies for congenital defects, immune disorders, and degenerative diseases.
2. Technology Development & Innovation
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Bioprocess Design
Developing automated, scalable protocols for stem cell expansion, differentiation, and characterization to enable robust and reproducible manufacturing.
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Biomaterial Science
Designing biomaterials and scaffolds that enhance cell culture, differentiation, and integration in tissue engineering applications.
3. Quality, Standards & Compliance
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Standardization
Implementation of validated SOPs, rigorous quality control, and reproducibility checks for all research and cell manufacturing processes.
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Ethical Oversight
Following international guidelines such as ISSCR recommendations, focusing on transparency, patient welfare, informed consent, and data integrity.
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Long-term Monitoring
For clinical translation, include long-term tracking of outcomes, adverse effects, and reporting of results (positive, negative, or inconclusive).
4. Collaboration & Multi-disciplinarility
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Academic & Clinical Partnerships:
Integrating basic, translational, and clinical research with strategic collaborations between academia, clinics, and industry to expedite innovation and application.
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Interdisciplinary Teams
Fostering a community of biologists, clinicians, bioengineers, geneticists, and data scientists to address complex problems from multiple angles.
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Shared Infrastructure
Leveraging core facilities and technology platforms for stem cell characterization, genome manipulation, and omics approaches.
5. Translational Pipeline
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Preclinical Validation
Performing comprehensive preclinical studies (disease models, efficacy, safety/toxicity) before proceeding to human trials.
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Clinical Trials
Designing carefully phased clinical studies, emphasizing gradual risk escalation, patient protection, rigorous controls, and competitive effectiveness assessment.
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Regulatory Engagement:
Liaising early with health regulatory authorities to ensure compliance, address biosafety, and facilitate product approval pathways.