PTB lecture 6

Question 1

peptides

Answer 1

polypeptides having <40 amino acids, don’t have a tertiary structure

Question 2

proteins

Answer 2

polypeptides having >40 amino acids, do have a tertiary structure

Question 3

cold chain

Answer 3

proteins should be stored and transported refrigerated (2-8 graden)

Question 4

cold chain monitor card

Answer 4

turns color when it is not cold enough, not usable anymore

Question 5

chemical instabilities

Answer 5

involve chemical reactions that make or brake covalent bonds, generating new chemical entities

Question 6

physical instabilities

Answer 6

the chemical composition remain unaltered, but the three dimensional structure is changed

Question 7

freeze drying

Answer 7

freezing and dehydration stresses

Question 8

spray drying

Answer 8

shear, thermal and dehydration stresses

Question 9

spray freeze drying

Answer 9

shear, freezing and dehydration stresses

Question 10

stabilization by water replacement

Answer 10

H-bonds between biopharmaceutical and H2O are replaced by H-bonds between biopharmaceutical and sugar-OH

Question 11

stabilization by vitrification/shielding

Answer 11

formation of a protective sugarcoating around the protein, protein is shielded from the environment (oxygen/light)

Question 12

drying, removal of water by…

Answer 12

sublimation or evaporation