Pharmaceutical Products and Their Indications

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Questions and Answers

Who discovered insulin in 1921?

Frederick Banting (correct)

Herbert Boyer

J.J.R.Macleod

Stanley Cohen

What was the outcome of the human clinical trials using insulin to treat diabetes in 1922?

No significant improvement

No trials were conducted

Remarkable success (correct)

Mixed results

What is the name of the technology that allows DNA from different species to be cut and pasted together?

Gene Editing

Recombinant DNA Technology (correct)

Cloning

Bioreactor Technology

What is the purpose of a bioreactor in the production of recombinant human insulin?

To allow bacteria to multiply and produce large quantities of human insulin Signup and view all the answers

Who founded the first biopharmaceutical company, Genentech?

Herbert Boyer and Stanley Cohen Signup and view all the answers

What was Frederick Banting awarded in 1923 for his work on insulin?

Nobel Prize in Medicine Signup and view all the answers

What is the term for the combination of DNA from different species?

Recombinant DNA Signup and view all the answers

What is the name of the first biologic drug?

Insulin Signup and view all the answers

What is the purpose of inserting DNA encoding for insulin into E. coli bacteria?

To produce ultra pure crystals of human insulin Signup and view all the answers

What is a potential issue of obtaining insulin from animal sources?

Risk of transmitting diseases from animals to humans Signup and view all the answers

What is a consequence of viral contamination in biopharmaceutical development?

Long term facility shutdowns for decontamination/reboot Signup and view all the answers

What is a type of viral contamination reported in large-scale cell culture processes?

MMV (mouse minute virus) Signup and view all the answers

What is a guideline for biosafety protocols in bioprocess manufacturing facilities?

Guidelines for Process Safety in Bioprocess Manufacturing Facilities Signup and view all the answers

What is an example of an incident related to products of biologic origin?

Contamination of eye drops with Pseudomonas aeruginosa Signup and view all the answers

What is a benefit of using recombinant DNA technology for insulin production?

Reducing the risk of transmitting diseases from animals to humans Signup and view all the answers

What is a consideration for biosafety protocols in bioprocess manufacturing facilities?

All of the above Signup and view all the answers

Which of the following cell lines is commonly used for biologics production?

CHO Signup and view all the answers

What is a desirable characteristic of cell culture media in biopharmaceutical development?

Chemically defined and serum-free Signup and view all the answers

Which of the following is NOT a type of virus assay used in industry?

Western blot Signup and view all the answers

What is a concern in open biomanufacturing facilities?

Biosafety risks Signup and view all the answers

Which of the following cell lines is commonly used for recombinant protein expression?

HEK-293 Signup and view all the answers

What is the purpose of in-process control testing in biopharmaceutical development?

To detect viral contaminants Signup and view all the answers

What is a risk management workflow used in biopharmaceutical development?

ICH quality risk management workflow Signup and view all the answers

What is a concern in a HEK-293 perfusion plant process expressing a recombinant protein?

Viral contamination risk Signup and view all the answers

Study Notes

Products and Indications

Factor VIII: used to treat Hemophilia A
Tissue plasminogen activator: used to treat Myocardial infarction
Erythropoietin: used to treat Anemia
Kymriah: used to treat Acute lymphoblastic leukemia and large B cell lymphoma
GLP-1: used to treat Type 2 diabetes
Insulin: used to treat diabetes

Discovery of Insulin

Insulin was discovered by Frederick Banting in 1921 at the University of Toronto
Banting and Best treated diabetes using pancreatic extracts from dogs
Human clinical trials using insulin to treat diabetes were conducted in 1922 with remarkable success
Frederick Banting and J.J.R.Macleod were awarded the Nobel Prize in 1923 for their work on insulin

Production of Insulin

Insulin can be sourced from pigs and cows
Recombinant DNA technology was developed in 1973 by Herbert Boyer and Stanley Cohen
This technology allowed for the creation of recombinant human insulin
Recombinant human insulin is produced by inserting the human insulin gene into E. coli bacteria, which multiply and produce large quantities of human insulin in a bioreactor

Biosafety Importance

Eye drops contaminated with Pseudomonas aeruginosa caused 80 infections, 4 deaths, and 14 cases of loss of vision
Viral contamination in biopharmaceutical industries can have significant consequences, including product impact, facility shutdowns, and disruption of medicine supply to patients
Typical hazards in biologics include virus contamination, product impact, and facility shutdowns

Biosafety Considerations

Approved cell lines for pharma (biologics) include E. coli, Saccharomyces cerevisiae, Pichia Pastoris, CHO, BHK, Murine myeloma, Hybridomas, HEK293, and HT-1080
Raw materials for cell culture media include water, low molecular weight nutrients, non-nutritive components, and high molecular weight factors
In-process control testing for virus assays includes in vitro viral assay, in vivo viral assay, transmission electron microscopy (TEM), Mouse Antibody Production (MAP), and qPCR

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Description

This quiz covers various pharmaceutical products, including Factor VIII, Tissue plasminogen activator, Erythropoietin, Kymriah, GLP-1, and Insulin, and their corresponding indications. It also touches on the discovery of Insulin by Frederick Banting.