Section outline

  • The chapter covers biopharmaceutical production, including fermentation, cell culture, purification, formulation, quality control, regulatory considerations, and Good Manufacturing Practices (GMP) for safe and effective biotech drug development.

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      Pharmaceutical Production of Biotech Products File
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      Human Insulin Production: The hormone insulin is essential for the control of blood sugar levels. Diabetes mellitus is a disease in which some people cannot make insulin themselves. This disease kills many people in the world every year.


      Hepatitis B Vaccine Production: Hepatitis B (HB) is one of the most common infectious diseases known to man. Recombivax HB was approved as a hepatitis B prevention vaccine in July 1986. Using recombinant DNA technology, Recombivax HB uses the surface antigen of the virus that stimulates the production of protective antibodies which combat the HB virus.