Question | Answer |
purity | the absence of impurity |
sterility | free from microorganims |
pyrogenicity | the ability to cause fever |
use these to increase solubility, so the hydrophobic protein can stay dissolved: | small amount of detergent, salts |
aggregation is going to happen so, how can we make it not stick to other molecules? | Put in another protein: albumin, other proteins, coat surfaces so the recombinant protein will not stick to the surface |
add these excipients for pH | a buffer to neutralize
NOT bicarbonate
Phosphate buffered saline (PBS), acetate, and citrate are good |
dissolved in oxygen? | sealed vial under nitrogen, antioxidant like ascorbic acid |
Natural antioxidant | glutathione |
how do you make glutathione? | use three peptides: glutamine, cystine, glycine |
which one of the three amino acids in glutathione is the antioxidant | cystine because of the sulfur group |
Preservatives used as excipients | bacteriostatic stuff (inhibit growth but does not kill), mercury compound, phenol, beta hydroxy benzoic acids, alcohol |
hydration excipients are used for what? | to stabilize the protein |
hydration excipients: | polyethylene glycol, other poly alcohol, sugars (dextrose), and salts |
substances or containers to which proteins in solution may adhere to | container that is glass (hydrophobic)
plastic, rubber stopper, almost any surface is hydrophobic |
1st step in freeze drying | freeze the solution |
2nd step in freeze drying | primary drying (begin the sublimation) |
primary drying | most of the water comes off now, use low pressure, and maintain temperature, have to slowly add heat to maintain the temperature |
freeze the solution | ice crystals form |
3rd step in freeze drying | secondary drying- that last little water needs to come off |
secondary drying | maintain the pressure, heat up the sample slowly |
some proteins are stored at: | room temperature, refrigerator temperature, or even lower temperatures |
which of the 3 is going to be the fastest: IM, IV, or SC? | IV is the fastest |
why might it be bad if IM and SC hold onto the protein and let it go slowly into the bloodstream? | because the protein could be exposed to proteases and can be degraded if it is just sitting around |
if you do not like needles? | rectal, inhalation, buccal, nasal, vaginal, transdermal patch |
what is a good route of administration for people who are vomiting | rectal |
absorption enhancers | iontophroesis. it disrupts the skin to let the drug across the skin |
iontophroesis | electric current to let the proteins into the skin |
main goal of absorption enhancers | disrupt the skin |
open loop delivery methods: | the open loop is used because the delivery is continuous not responding to changes in data |
what happens if you close the loop? | you take the data you are collecting and utilize/analyze it. then make changes based on that analysis. reassess |
mechanical pumps (Open loop delivery methods) | embed in patients and delivers drug when needed |
osmotically driven systems (open loop) | put is surgically. give a slow steady release. water pumps out the drug |
conjugate a protein into some other molecule (open loop) | join with another molecule like polyethylene glycol. it increases the time that the protein stay at the injection site (slowly released) |
PLGA- polulactic/polyglycolic acid (open loop) | the protein is protected by micro spheres and it stays at the injection site longer |
closed loop systems include | biosensor, algorithm, pump system |
algorithm | calculates the required input rate for delivery |
monospecific antibodies are identical because... | they are produced by one type of immune cell that are all clones of a single parent cell |
immunoconjugates are.. | antibodies conjugated to a second molecule, usually a toxin like ricin |
what are immunoconjugates used for | used in immunotherapy and to develop monoclonal antibody therapy as chemotherapy |
bispecific monoclonal antibody | are manufactured from two separate antibodies to create a molecule with two different binding sites |
colloidal particulate carrier systems: | liposomes, albumin microspheres, biodegradable polycyanoacrylate nanoparticles, polylactic acid microspheres, LDL |
potential advantages of colloidal particulate carrier systems | macrophages encapsulate the drug to protect from degradation. they are similar to the rate-controlled delivery methods because they can persist in the blood for hours to days. |
disadvantages of colloidal particulate carrier systems | they cannot permeate through membranes |