Integrated Translational Biomedical Center

Core Verticals

  • Optimization and Characterization of Nano-Appended Drug Delivery Systems
  • in-vitro Preclinical CRO
  • Analytical Method Development and Validation Lab
  • Scientific Writing

1. Core Vertical

  • Optimization & Characterization of Nano-Appended Drug Delivery Systems

2. Core Vertical

  • Cell-Based Preclinical CRO (Mechanistic Validation Arm)

3. Core Vertical

  • Analytical Method Development and Validation Lab

4. Core Vertical

Scientific Writing

1. INTRODUCTION

What is known? (our understanding)

2. LITERATURE REVIEW

what’s the gap we want to fill?

3. RATIONAL

Why and how should we fill the gap?

4. METHODS

What did you do

5. RESULT AND DISCUSSION

What results did you get ? How do the results fill the gap?

6. CONCLUSION

What does this mean for us going forward?

7. SUMMARY

8. REFERENCES

Where have you collected the information?

Nanoformulation Validation Framework

Pre-formulation/compatibility studies

Nanoformulation development by QbD approach

Optimization

Characterization

Optimized formulation validation

In-vitro Release profile

Reproducibility by Pilot studies

Reproducibility by Batch to Batch

Encapsulation efficiency consistency

Controlled Release modelling

Stability

Aggregation behaviour

Packaging

HPLC Analytical Method Development

Screening of the column and mobile phase on the basis of the drug molecule properties Method development at different ratios of the mobile phase on the single drug/combination drug

Optimization of the developing method via QbD Approach

Validation of the optimized method:

Specificity

Linearity

Accuracy

Precision

LOD/LOQ

Robustness

System suitability