What's the REGN Drug
What drug treats Age-Related Macular Degeneration?
A. EYLEA HD
B. DUPILUMAB
C. VEOPOZ
D. LIBTAYO
A. EYLEA HD
Regeneron's headquarters are located in Albany, NY
False its Tarrytown
This neurologist founded Regeneron in 1988 and then recruited a young Columbia scientist in the following year. These people are?
Leonard Schleifer and George Yancopoulos
During an inspection, employees should answer questions truthfully and based on SOP/principle; if you DON’T know, DON’T (fill in the blank)
Guess the answer
What ailment will REGN1908 be treating
Cat allergies
What drug treats Atopic dermatitis?
A. KEVZARA
B. LYNOZYFIC
C. OTARMENI
D. DUPIXENT
D. DUPIXENT
Regeneron's first FDA approved medicine in 2008 was for eczema
False it was for Arcalyst
What major global health crisis did REGN help address by developing antibody therapies?
Covid-19
What type of audits are there? Please name who can carries out these audits
1. Internal (REGN's GMP auditing team)
2. External (Sanofi, FDA, HPRA)
Why are shield used before viral filters?
A. To increase product concentration
B. To sterilize the pool
C. To optimize flux and remove foulants or aggregates
D. To lower conductivity
C. To optimize flux and remove foulants or aggregates
What drug treats High Cholesterol
PRALUENT
Monoclonal antibodies are one type of therapy developed by Regeneron
True
Where does the name Regeneron come from?
A. Genetic engineering research
B. A combination of the founder's names
C. Regenerative medicine and oncology
D. Regenerating neurons
D. Regenerating neurons
What does ALCOA+ stand for
1. Attributable
2. Legible
3. Contemporaneous
4. Original
5. Accurate
6. Complete
7. Consistent
8. Enduring
9. Available
What is the primary purpose of viral filtration?
A. Concentrate product protein
B. Remove viral contaminants based on size exclusion
C. Adjust pH of the product pool
D. Remove endotoxins only
B. Remove viral contaminants based on size exclusion
What drug does REGN17372 target?
A. Multiple Myeloma
B. Leukemia
C. Lymphoma
D. Myeloproliferative Neoplasms
A. Multiple Myeloma
If a drug target is genetically associated with a disease, it is guaranteed to become a successful medicine
False
Which medicine is responsible for Regeneron's transition to becoming a major commercial biotech company?
A. ARCALYST
B. KEVZARA
C. EYELA
D. PRALUENT
C. EYELA
Inspectors can look into anything and everything at any given time. What are important principles to maintain on and off the floor?
1. Safe, Clean, and Compliant (SCC)
2. ALCOA+
During vial thaw in seed train the conical tube with the cell culture is spun down in a centrifuge resulting in the form of a pellet. The excess media is poured out into a trash conical and only the pellet is kept. Why is that?
Dimethyl Sulfide (DMSO) is toxic to cells resulting in cell death.
What are 2 out of the 3 types of cancer that LIBTAYO treats
Cutaneous squamous cell carcinoma
Basal Cell carcinoma
Non-small Lung Cancer
Regeneron's drug product sequence is
1. Development and Research
2. Discovery and Validation
3. Clinical Development
4. Manufacturing
False
What technology was selected as the technology of choice by the National Institutes of Health in the Knockout Mouse Project in 2006
VelociGene
What specific source can be used to be ready for inspection?
CBT-GE0388
What air sparger on the 2k bioreactor creates larger air bubbles?
A. The Primary Air Sparge (frit)
B. The Secondary Air Sparge (drilled hole)
Secondary Air Sparge