Phar433 Final

Question 1

Define the biotechnology in general terms.

Answer 1

Use of Bioloical Entities (cells / organisms) to produce a product.

Ex.
Beer Making / Fermentation

Question 2

Understand general techniques used in the production of
biotech drug products.

Source Materials:
Call Cultures / Bacteria / yeast
Humans / Rodents / TRANSGENIC organisms

Answer 2

First was:

• *Antibiotics –> microbiology & fermentation techologies**
• *IN VIVO SYNTHESIS**

Recombinant DNA

Monoclonal Antibodies

Polymerase chain Reaction = PCR

Gene Therapies = CRISPR

Question 3

Describe how biologic drugs differ from small molecule drugs

Answer 3

• *Small Molecule**
• Low MW* / Organic or Chemical Structure
• fewer critical steps* // Well-characterized = Known structure
• *Homogenous substance**
• usually NOT IMMUNOGENIC*

BIOLOGIC DRUGS
HIGH MW / Living organism
MANY steps / difficult chracterizations = Idk structure
HETEROgenous
OFTEN IMMUNOGENIC

Question 4

Describe considerations for working with biologics.

Answer 4

Paramaters to consider:
Physical / Chemical Properties
STORAGE requirements
Physical Treatment during dosage form prep
–> DO NOT SHAKE PROTEINS
diluent composition & properties = pH / Salts

Biosimilar =/= Generic
can decrease costs / saves TIME to produce

Question 5

Identify sources of information regarding biotechnology regulations and drug products.

Answer 5

Package Inserts

FDA

PURPLE BOOK
Lists lists of licensed biological products

Biosimilars
biological product that is highly similar to and has NO clinically eaingful differences from an existing product.