How Biologic Medicines Are Made | How It's Made
Summary
TLDRThis script outlines the production process of biologic medicines, which are proteins created in living cells. It begins with the insertion of genetic material into CHO cells, followed by cell multiplication in growth media. The cells are then transferred to a bioreactor where they exponentially increase, producing the target protein. The protein is purified through a series of steps, including separation from cellular material and a purification solution process. The final product is tested for sterility, highlighting the meticulous process behind these life-changing medicines.
Takeaways
- 🧬 Biologic medicines are proteins produced inside living cells, offering a different approach from traditional chemically synthesized drugs.
- 🔬 Chinese hamster ovarian cells (C.H.O. cells) are used as the host cells for producing biologic medicines.
- ❄️ C.H.O. cells are stored frozen in liquid nitrogen until needed for production.
- 🌡️ In the seed lab, cells are thawed in warm water and transferred to a growth media containing essential nutrients to promote cell multiplication.
- 🧪 The growth media is a crucial component, providing vitamins and minerals necessary for cell growth and multiplication.
- 🌱 The cells are transferred to a bioreactor where a propeller agitates the mixture to stimulate growth over a three-week period.
- 📈 The number of cells increases exponentially, each programmed to produce the target biologic protein.
- 🧴 The purification process involves measuring salts and other dry ingredients to prepare a solution for protein separation.
- 🏷️ Technicians label and record information about the ingredients and processes as required by government regulations.
- 🔄 An automated system monitors the purification solution's condition after cellular material is separated from the protein mixture.
- 🔬 Purification involves pumping the mixture through columns containing resin beads to separate the protein from impurities.
- 🌡️ A final test is conducted to ensure the medicine is sterile before it is ready for use.
Q & A
What are biologic medicines?
-Biologic medicines are proteins produced inside living cells, which serve as mini factories for genetically-engineered protein treatments.
How do biologic medicines differ from traditional drugs?
-Biologic medicines are produced using living cells, whereas traditional drugs are manufactured using chemical synthesis.
What role do Chinese Hamster Ovarian (CHO) cells play in the production of biologic medicines?
-CHO cells are used as the host cells into which genetic material is inserted to produce the target biologic protein.
Why are the CHO cells kept frozen in liquid nitrogen?
-CHO cells are kept frozen in liquid nitrogen until needed for the production process to preserve their viability and ensure consistency.
What is the purpose of the growth media in the production process?
-The growth media, containing hundreds of nutrients including vitamins and minerals, is used to help the cells multiply and support their growth.
How does the process of cell multiplication occur in the bioreactors?
-The mixture containing the cells is injected into a bioreactor where a propeller agitates the mixture to stimulate growth, leading to an exponential increase in cell numbers over a three-week period.
What is the function of the purification process in the production of biologic medicines?
-The purification process is used to separate the target biologic protein from the cells and other impurities, ensuring the medicine is pure and sterile.
How is the protein liquid prepared for purification after it has been separated from the cells?
-A technician measures salts and other dry ingredients to prepare a recipe for purifying the protein liquid, which is then added to purified water in a mixing tank.
What is the role of the steel-and-glass columns in the purification process?
-The protein mixture is pumped through steel-and-glass columns where a purification solution works with resin beads to separate the protein from impurities.
How is the sterility of the final biologic medicine ensured?
-A technician takes a sample of the purified medicine and conducts a test to ensure it is sterile before it can be used for treatment.
What is the potential impact of biologic medicines on people's lives?
-Biologic medicines offer hope where other therapies have failed, potentially making a significant difference in the lives of patients by providing effective treatments for various conditions.
Outlines
🧬 Biologic Medicines Production
Biologic medicines are proteins produced within living cells, which serve as mini factories for genetically-engineered protein treatments. This contrasts with traditional drugs made through chemical synthesis. Biologics offer new hope for conditions where other therapies have failed. The mass production of these medicines involves using the molecular machinery inside living cells, starting with the insertion of genetic material into Chinese hamster ovarian cells, known as C.H.O. cells. These cells are kept frozen in liquid nitrogen until needed. In the seed lab, a technician thaws the cells in warm water and transfers them to a glass flask containing growth media, which is a nutrient-rich mixture that includes vitamins and minerals to help the cells multiply. The flask is then moved to the production side of the plant, where the mixture is injected into a bioreactor. Over a three-week period, the number of cells increases exponentially, each programmed to produce the target biologic protein.
Mindmap
Keywords
💡Biologic Medicines
💡Living Cells
💡Genetic Engineering
💡Seed Lab
💡Growth Media
💡Bioreactor
💡Exponential Growth
💡Purification
💡Resin Beads
💡Sterility Testing
Highlights
Biologic medicines are proteins produced inside living cells, offering a different approach from traditional chemically synthesized drugs.
Biologics are genetically-engineered protein treatments that can offer hope where other therapies have failed.
Scientists use the molecular machinery inside living cells to mass produce biologic medicines.
The process begins with the insertion of genetic material into Chinese hamster ovarian cells, known as C.H.O. cells.
C.H.O. cells are kept frozen in liquid nitrogen until needed for the production process.
In the seed lab, cells are thawed in warm water and transferred to a glass flask with growth media.
Growth media contains hundreds of nutrients, including vitamins and minerals, to help cells multiply.
The flask with cells is transferred to a bioreactor, where a propeller agitates the mixture to stimulate growth.
Over a three-week period, the number of cells increases exponentially, each programmed to produce the target biologic protein.
Technicians prepare a recipe for purifying the protein liquid, which includes measuring salts and other dry ingredients.
The purification process is recorded and labeled in accordance with government regulations.
Ingredients are added to purified water in a mixing tank, and an automated system monitors the purification solution.
The protein mixture is separated from cellular material and pumped through columns for purification.
Resin beads in the columns work with the purification solution to separate the protein from impurities.
A technician takes a sample and conducts a test to ensure the medicine is sterile before it is ready for use.
These biologic medicines, grown in living cells, have the potential to make a significant difference in people's lives.
Transcripts
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Narrator: BIOLOGIC MEDICINES ARE PROTEINS
PRODUCED INSIDE LIVING CELLS,
WHICH ARE MINI FACTORIES
GENERATING THE GENETICALLY-ENGINEERED
PROTEIN TREATMENTS.
IT'S A DIFFERENT APPROACH FROM TRADITIONAL DRUGS,
WHICH ARE MANUFACTURED USING CHEMICAL SYNTHESIS.
BIOLOGICS OFFER HOPE WHERE OTHER THERAPIES HAVE FAILED.
TO MASS PRODUCE THESE BIOLOGIC MEDICINES,
SCIENTISTS USE THE MOLECULAR MACHINERY
INSIDE LIVING CELLS.
THE PROCESS STARTS WITH
THE INSERTION OF GENETIC MATERIAL
INTO CHINESE HAMSTER OVARIAN CELLS.
THEY'RE KNOWN AS C.H.O. CELLS.
THEY KEEP THEM FROZEN IN LIQUID NITROGEN
UNTIL THE NEXT STEP.
IN THE SEED LAB,
A TECHNICIAN THAWS THE CELLS IN WARM WATER.
HE TRANSFERS THEM TO A GLASS FLASK
THAT CONTAINS GROWTH MEDIA.
THE GROWTH MEDIA IS COMPRISED OF HUNDREDS OF NUTRIENTS,
INCLUDING VITAMINS AND MINERALS.
IT'S A RECIPE TO HELP THE CELLS MULTIPLY.
A WORKER TRANSFERS THE FLASK THAT CONTAINS THE CELLS
TO THE PRODUCTION SIDE OF THE PLANT.
THE TEAM INJECTS THE MIXTURE
INTO A FIVE-GALLON CAPACITY BIOREACTOR.
INSIDE, A PROPELLER AGITATES THE MIXTURE
TO STIMULATE GROWTH.
OVER A THREE-WEEK PERIOD,
THE NUMBER OF CELLS INCREASES EXPONENTIALLY.
EACH NEW CELL IS PROGRAMMED TO PRODUCE
THE TARGET BIOLOGIC PROTEIN.
NEXT, A TECHNICIAN MEASURES SALTS AND OTHER DRY INGREDIENTS.
HE'S PREPARING A RECIPE FOR PURIFYING THE PROTEIN LIQUID
ONCE IT'S BEEN SEPARATED FROM THE CELLS.
HE LABELS THE BAG
AND RECORDS THE INFORMATION SEPARATELY,
AS REQUIRED BY GOVERNMENT REGULATIONS.
HE ADDS THE INGREDIENTS TO PURIFIED WATER
IN A MIXING TANK.
AN AUTOMATED SYSTEM KEEPS TABS ON THE CONDITION
OF THE PURIFICATION SOLUTION.
AFTER SEPARATING CELLULAR MATERIAL
FROM THE PROTEIN MIXTURE,
THE TEAM PUMPS IT THROUGH STEEL-AND-GLASS COLUMNS.
HERE, THE PURIFICATION SOLUTION WORKS WITH RESIN BEADS
TO SEPARATE THE PROTEIN FROM THE IMPURITIES.
FINALLY, THIS TECHNICIAN TAKES A SAMPLE
AND CONDUCTS A TEST TO ENSURE THE MEDICINE IS STERILE.
GROWN IN LIVING CELLS,
THESE BIOLOGIC MEDICINES ARE NOW ON THEIR WAY
TO POTENTIALLY MAKING A DIFFERENCE IN PEOPLE LIVES.
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