The Production of Medicines

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THE PRODUCTION OF MEDICINES

By Angel Mutesva
MAKING MEDICINES

• Making medicine is a long, complicated and expensive process

• Examples of medicine types: biopharmaceutical and pharmaceutical


BIOPHARMACEUTICAL

• A medicinal product manufactured in extracted or semi-synthesized biological


sources like humans, animals or microorganisms.
• It consists of sugars, proteins, nucleic acids, living cells or tissues.
• The majority of biopharmaceutical are derived from biological processes
including the extraction living systems or the production by recombinant DNA
technologies.
• Transgenic organisms, especially animals, plants or microorganisms that have
been genetically modified, can be used to produce biopharmaceuticals.
• Transgenic: relating to or denoting an organism that contains genetic material
which DNA is from an unrelated organism that has been artificially introduced
• Recombinant: relating to or containing genetically engineered DNA.
EXAMPLES OF BIOPHARMACEUTICALS

• Proteins: antibodies and biosimilars


• Peptides
• Cells: stem cells
• Organs and tissues
• Vaccines
• Gene Therapy Medicinal Products: AAV based therapeutics
• AAV stands for Adeno-associated virus
RISKS

• There are no risks only disadvantages


• It is expensive
• Can induce antidrug antibodies leading to decreased efficacy or deficiency
• Efficacy: effectiveness
BENEFITS

• Target only specific molecules, which makes it rare for side effects to occur.
• Their vaccines are considered the most effective strategies for disease control
• The vaccines bring prevention in advance and long term immunity
• They are able to cure or treat diseases safely and effectively
• Cost can be reduced by using biosimilars
• Biosimilar:
COMPARISON BETWEEN A GENERIC
DRUG AND BIOSIMILAR
Drug property Generic drug Biosimilar

Molecular size Small (~150 Da) Large (~150,000 Da)


Structure Simple and well-defined Complex with probable structural variations
Characterization Easy Difficult
Stability More stable for storage and handling Less stable, very sensitive to its surroundings
Production Predictable chemical processes are Specialized biological processes are used to
used to manufacture an identical copy manufacture a similar copy
Identical to reference products Yes No
At least, active pharmaceutical Minor differences in clinically inactive components
ingredients are identical are acceptable
Adverse immune responses Lower potential Higher potential
Frequency of quality tests in manufacturing ≤50 ≥250
Clinical trials requirement for approval Small clinical trials in healthy Large clinical trials in patients
volunteers
Discovery cost Low or even no Relatively high
DIAGRAMS
CONCLUSION

• Biopharmaceuticals are very promising for disease control and prevention


• Their characteristics and multiple advantages make them better than traditional
drugs
• They are still being developed to this day.

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