Biotechnology

Question 1

types of large molecules used in the biopharmaceuticals/biotechnology products

Answer 1

proteins, peptides, DNA/RNA and antibodies.

Question 2

Structural features of proteins

Answer 2

Proteins/ peptides via amino acid chains: differentiated by the length of the AA chain with peptides less than 30 or 40 amino acids and proteins greater than 30 to 40 AA.

Question 3

Biological activity structure

Answer 3

regular regions of chain interactions (secondary structure via Alpha helix or beta pleated sheets) that is responsible for protein activity since it affects binding to active sites.

Question 4

General steps involved in recombinant production

Answer 4

isolate gene responsible for protein synthesis
Insert gene into DNA from yeast or bacterial cell
grow yeast or bacteria with protein being expressed
Isolate the protein from cells (dependent on location and can be broken easily)

Question 5

how formulating a biotechnology product is similar to and different from formulation of small molecule products

Answer 5

Much more limited to smaller molecules
Can undergo physical and chem degredation
consider before formulation

Question 6

Denaturation

Answer 6

the breaking of many of the weak linkages, or bonds (e.g., hydrogen bonds), within a protein molecule that are responsible for the highly ordered structure of the protein in its natural (native) state. Higher temperatures can denature proteins and low temperature can inactivate or require heat shock prior to use.

Question 7

Fragmenting

Answer 7

a protein being either broken down or cause to break into smaller fragments

Question 8

Adsorption

Answer 8

adhesion of atoms, ions or molecules from a gas, liquid or dissolved solid to the surface. Biopharm may require surfactants at low concentrations to decrease this process from occurring.

Question 9

Aggregation

Answer 9

clustering of molecules that come together. This will decrease also when adding a surfactant.

Question 10

Common Route for Biotech products

Answer 10

Inhalation: shown to have similar plasma concentration profiles as injectable drug delivery. Mitigated formulation issues such as pH, ionic strength, mixing and solubility. Allowed for formulation to focus on temperature stability and inhalation delivery.

Question 11

Common route for biotech products

Answer 11

Injectable is the most common route that biologics are given since gastric pH and gastric enzymes would be degraded by oral delivery. Usually given subcutaneously