Biologic Medicines Production

Overview

• Biologic medicines are proteins produced in living cells.
• They are genetically engineered treatments.
• Different from traditional drugs made through chemical synthesis.
• Offer hope where other therapies have failed.

Production Process

1. Cell Preparation

   • Start with Chinese Hamster Ovarian (CHO) Cells.
   • Insert genetic material into CHO cells.
   • Cells kept frozen in liquid nitrogen until needed.

2. Seed Lab

   • Cells thawed in warm water.
   • Transferred to a glass flask with growth media.
   • Growth media contains hundreds of nutrients (vitamins and minerals) to aid cell multiplication.

3. Bioreactor Phase

   • Flask transferred to production side of the plant.
   • Mixture injected into a five-gallon capacity bioreactor.
   • A propeller agitates the mixture to stimulate growth.
   • Over three weeks, cell numbers increase exponentially.
   • Each new cell is programmed to produce the target biologic protein.

4. Purification Preparation

   • Technician measures salts and dry ingredients for purification recipe.
   • Ingredients added to purified water in a mixing tank.
   • Automated system monitors the purification solution's condition.

5. Protein Purification

   • Cellular material separated from protein mixture.
   • Pumped through steel-and-glass columns.
   • Purification solution works with resin beads to separate protein from impurities.

6. Quality Control

   • Technician takes a sample for testing to ensure sterility.

Conclusion

• Biologic medicines, grown in living cells, have the potential to make significant differences in people's lives.