Definition:
Biotechnological products are therapeutic substances that are produced using living organisms, cells, or biological systems through recombinant DNA technology or other biotechnological processes.

Examples of Biotechnological Products

1. Recombinant Proteins:
   e.g., Human insulin, Interferons, Erythropoietin.

2. Monoclonal Antibodies (mAbs):
   e.g., Trastuzumab, Adalimumab.

3. Vaccines:
   e.g., Hepatitis B vaccine, HPV vaccine.

4. Gene Therapy Products:
   e.g., Luxturna (for retinal dystrophy).

5. Cell-based Therapies:
   e.g., CAR-T cell therapy.

6. Fusion Proteins and Growth Factors:
   e.g., Etanercept, Filgrastim.

Quality Considerations

• Source Materials: Control of cell banks and expression systems.

• Manufacturing Process: Must be consistent, sterile, and validated.

• Analytical Characterization: Purity, potency, identity, and stability testing.

• Stability Studies: As per ICH Q5C guidelines.

• Process Validation: Ensures reproducibility and product quality.

• Regulatory Guidelines:

  • ICH Q5A – Q5E series

  • WHO and EMA guidelines

  • US FDA Guidance for Industry – Biotechnology Products

Key ICH Guidelines Related to Biotechnology

Summary

Biotechnological products are complex molecules whose quality depends heavily on the control of biological processes. Strict adherence to ICH Q5 guidelines ensures product safety, efficacy, and consistency.