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P1 Spring - Pharmaceutics II > Case 5 > Flashcards

Case 5 Flashcards

1
Q

biotechnology

A

any technique that uses living organisms (bacteria, yeast, mammialian) in the production or modification of products used to affect human health and human environment; macromolecules

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2
Q

biotechnoloy products include

A

proteins, DNA, RNA, MABs

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3
Q

biotechnology is used to

A

treat diseases, prevent and diagnose

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4
Q

the first biotech product was

A

insulin, banting and best, Univ of Toronto; 1912

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5
Q

insulin

A

comes fro the pancreatic islet cels and insulin is isolated from animals (first cows then pigs), now recombinant human insulin is used

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6
Q

problems with insulin from animals

A

impurities, allerigies, contaminants

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7
Q

rDNA

A

recombinant DNA; proteins, MABs

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8
Q

PCR

A

polymerase chain reaction; proteins, gene therapy, antisense NAs, large scale production

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9
Q

antibody production via hybridoma technology

A

MABs

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10
Q

cohen boyer method

A

makes rDNA

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11
Q

step 1 of cohen boyer method

A

DNA is first cut into smaller lengths with ECORI which recognize specific sequences of base pairs and cut the DNA at that point; the DNA sequence desired can therefore be removed and isolated

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12
Q

step 2 of the cohen boyer method

A

rDNA production
protein production begins by incorporating DNA of interest into the plasmid
ligase is used to connect ends of DNA fragment with the ends of the plasmid DNA effectively making a slightly larger circular unit

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13
Q

step 3 of the cohen boyer method

A

host cell selection and protein production
cloning can then be accomplished by inserting the rDNA into a host that replicates easily; bacteria, yeast, mammal cells,

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14
Q

bacterial hosts example

A

Ecoli

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15
Q

bacterial host advantages

A

replicate fast
cheap
simple proteins

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16
Q

bacterial host disadvantages

A

bacterial debris
pyrogens
antigens
cannot make post translational modifications (glycosylation)

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17
Q

Yeast host cell example

A

Saccharomyces cerevisiae

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18
Q

advantages of yeast cell hosts

A 
protein secretion
fast growth rate
large scale production
absense of pyrogens
not pathogenic
post translational modifications
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19
Q

disadvantages of yeast cell hosts

A

active proteases can degrade proteins

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20
Q

mammalian cell hosts example

A

chinese hamster ovary cells

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21
Q

mammalian cell host advantages

A

folding and post-translational modifications
contamination
more complex proteins

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22
Q

mammalian cell host disadvantages

A

cost

time

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23
Q

polymerase chain reaction

A

makes genes, proteins, antisense NAs; quick scale up

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24
Q

process of PCR

A

denaturation (heat up to separate)
annealing (introduce primers) cool
extension (introduce DNA polymerase) hot

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25
post translational modifications
often necessary to obtain a functional protein; glycosylation, proteolytic cleavage of a pro-peptide; disulfide bond formation, protein folding
26
post translational modifications fall into two broad categories
needed to produce a functional protein and that produce enhanced pharmacokinetic properties
27
glycosylation
most common post translational modification of proteins; attachement of polysaccharide chains to specific amino acid residues, carbohydrate components may play a variety of critical roles (bacteria hosts cannot do this)
28
pegylation
attachment to PEG, changes immune system response to them; proteins get hidden from the immune system like native proteins forms a shell around protein hinders metabolism increases circulation time
29
pegylation example
neupogen to neulasta half life increases longer acting once per chemo cycle admin
30
immunogenicity of biologics
``` anti antibody responses (AARs) antidrug antibodies (ADAs) ```
31
blockbuster product
$1 billion in sales 1st of its kind lead for new drug/biologics category
32
monoclonal antibodies
AAs; controls immune response to foreign materials; administered IV, SQ, IM, low BA and high chance for adverse drug reactions
33
antibodies
secreted by t lymphocytes
34
body makes polyclonal but monoclonal means
uniform structure, specific, derived, single clone of cells, specific gene sequence
35
MAbs
``` specifically target cell receptors RA, Metastatic breast cancer very specific (leads to small market) ```
36
best selling biologic
Humira (adalimumab) RA, CHO cells
37
MAbs use
CHO but 4 use Ecoli
38
1st MAb
OKT3 CD3 on Tcells or Orthoclone
39
latest MAb
Tecentriq CHO cells bladder and UT cancer combination therapy with Abraane for metastatic triple negative breast cancer
40
``` Mouse Chimeric Humanized Human which has higher immunogenicity and types associated with each ```
``` omab ximab zumab umab human = lowest immunogenicity ```
41
toxicities associated with MAbs
MAb antigen binding | mAb interactions with the target antigen on tissues other than the intended target
42
Fusion Proteins
``` Enbrel (Etanercept) blockbuster biological product Fusion of EC domain of TNF-a receptor and Fc portion of human IgG1 anti inflammatory disorders CHO cells ```
43
classes of biotech products
``` monoclonal antibodies synthetic immunommodulators recombinant vaccines recombinant hormones recombinant enzymes gene therapy and nucleic acid based engineered cell based purified proteins ```
44
growth factors or colon stimulating factors
``` ESAs (erythropoietin stimulating agents) CSFs (colony stimulating agents) safety concerns small molecule competition regulate process by which stem cells in bone marrow reproduce / differentiate admin: SQ or IV ```
45
colony stimulating factors (CSF) Neupogen
not glycosylated half life 3.5 hous daily dosing by injection to maintain its effects on bone marrow Ecoli
46
Neulasta
pegylation increases size of filgrastim too large for renal clearance retains the same biological activity binds to the same GCSF receptor stimulating the proliferation, differentation and activation of neutrophils 15-80 hour half life longer acting single dose compares to 11 doses of neupogen
47
Erythropoietin Stimulating Agents
Procrit/Epogen/Epoetin alfa half life of 4-13 hours mammalian cells Aranesp/Darbepoetin alfa extra glycoslyation carbohydrate linked components increased half life requires glycosylation for biologic activity CHO = host
48
cytokines
generally defined as soluble mediators or glycoproteins communication between cells in the immune, hematological or neurological systems 2 groups: Interferons and Interleukins Avonex IFN-B; relapsing multiple sclerosis, CHO cells
49
Vaccines
``` prophylactic and therapeutic Recombivax HB: Hep B 3 dose schedule has a surface antigen that will stimulate immune response antibody production in the body S. cerevisiae ```
50
hormones
insulin and its analogues administered SQ Lantus (insulin glargine) market leader in biotech hormones E Coli
51
Unique conditions for biotech products
1. biosimilars and interchangables 2. manufacturing 3. storage 4. admin
52
biosimilar
a biotherapeutic product which is similar in terms of quality safety and efficacy to an already licensed biotherapeutic product highly similar to a US licensed reference biological product nowithstanding minor differences in clinically inactive components and for which there are no clinically meainingful differeces between the biological product and the reference product in terms of safety, purity and potency of the product a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product
53
biosimilars
developed using unique biological systems and living cells analytical non clinical and clinical data needs to be similar to original in terms of structural characteristics, safety and efficacy requires high investment compared to generics
54
manufacturing a biotech
techniques used: rDNA technology PCR back in the day - hybridoma technology for MAbs
55
manufacturing process
large scale manufacturing plants intensive development work in cell line, media and bioreactor condition optimization, cell specific productivity hae allowed high titers up to 10 g/L and cell densities of over 20 million cells/mL in fed batch processes to be achieved all biotech products need to be sterile
56
storage
proteins are significantly more fragile than small molecule drugs extremes in temp can cause proteins to aggregate or damage 3D conformation usually stored at 4 degrees too much heat = denature dont want to freeze
57
stabilizing biotechnology products during storage
lyophilization "freeze dried" a technique that converts an aqueous solution of a protein into a solid elimination of water use vacuum use protectants to replace lost water and keep 3D/tertiary structure intact
58
reconstitution
``` before use if product was lyophilized most population - use bacteriostatic water for injection USP preservative SWFI for newborns do not use if solution is cloudy WFI = only use each vial once ```
59
admin variations for biotech products
therapy - self admin RA MS Psorisasis Conditions vaccines asthma immune disorders Chemotherapy cancer anemia neutropenia
60
self admin
``` demonstrate techniques to patients let them perform first injection under supervision importance of rotating injection sites - avoid site rxns safe disposal of needles and syringes storage instructions / light do not shake / agitate too much protein roll in the palms of hands importance of regiment compliance ```

P1 Spring - Pharmaceutics II (15 decks)

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