Questions and Answers
Who discovered insulin in 1921?
What was the outcome of the human clinical trials using insulin to treat diabetes in 1922?
What is the name of the technology that allows DNA from different species to be cut and pasted together?
What is the purpose of a bioreactor in the production of recombinant human insulin?
Signup and view all the answers
Who founded the first biopharmaceutical company, Genentech?
Signup and view all the answers
What was Frederick Banting awarded in 1923 for his work on insulin?
Signup and view all the answers
What is the term for the combination of DNA from different species?
Signup and view all the answers
What is the name of the first biologic drug?
Signup and view all the answers
What is the purpose of inserting DNA encoding for insulin into E. coli bacteria?
Signup and view all the answers
What is a potential issue of obtaining insulin from animal sources?
Signup and view all the answers
What is a consequence of viral contamination in biopharmaceutical development?
Signup and view all the answers
What is a type of viral contamination reported in large-scale cell culture processes?
Signup and view all the answers
What is a guideline for biosafety protocols in bioprocess manufacturing facilities?
Signup and view all the answers
What is an example of an incident related to products of biologic origin?
Signup and view all the answers
What is a benefit of using recombinant DNA technology for insulin production?
Signup and view all the answers
What is a consideration for biosafety protocols in bioprocess manufacturing facilities?
Signup and view all the answers
Which of the following cell lines is commonly used for biologics production?
Signup and view all the answers
What is a desirable characteristic of cell culture media in biopharmaceutical development?
Signup and view all the answers
Which of the following is NOT a type of virus assay used in industry?
Signup and view all the answers
What is a concern in open biomanufacturing facilities?
Signup and view all the answers
Which of the following cell lines is commonly used for recombinant protein expression?
Signup and view all the answers
What is the purpose of in-process control testing in biopharmaceutical development?
Signup and view all the answers
What is a risk management workflow used in biopharmaceutical development?
Signup and view all the answers
What is a concern in a HEK-293 perfusion plant process expressing a recombinant protein?
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
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
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.