Q5: Biotechnological Products
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
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Recombinant Proteins:
e.g., Human insulin, Interferons, Erythropoietin. -
Monoclonal Antibodies (mAbs):
e.g., Trastuzumab, Adalimumab. -
Vaccines:
e.g., Hepatitis B vaccine, HPV vaccine. -
Gene Therapy Products:
e.g., Luxturna (for retinal dystrophy). -
Cell-based Therapies:
e.g., CAR-T cell therapy. -
Fusion Proteins and Growth Factors:
e.g., Etanercept, Filgrastim.
Quality Considerations
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Source Materials: Control of cell banks and expression systems.
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Manufacturing Process: Must be consistent, sterile, and validated.
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Analytical Characterization: Purity, potency, identity, and stability testing.
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Stability Studies: As per ICH Q5C guidelines.
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Process Validation: Ensures reproducibility and product quality.
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Regulatory Guidelines:
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ICH Q5A – Q5E series
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WHO and EMA guidelines
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US FDA Guidance for Industry – Biotechnology Products
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Key ICH Guidelines Related to Biotechnology
| Guideline | Title/Focus |
|---|---|
| Q5A | Viral Safety Evaluation of Biotechnology Products |
| Q5B | Expression Constructs in Cells Used for Production |
| Q5C | Stability Testing of Biotechnological Products |
| Q5D | Derivation and Characterization of Cell Substrates |
| Q5E | Comparability of Biotechnological Products after Process Changes |
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.