biologics lecture 1 Flashcards
biologics
medications derived from or produce by living organisms
examples of biologics
recomibant proteins, peptide, blood factors, vaccines, oligonucleotides, mRNA, and cell-based therapies
small molecules
chemical synthesis, 90% of marketed drugs
recombinant proteins
cell culture
BIOLOGIC
mRNA, oligonucleotides
cell free
mrna COVID vaccines were #1 and #2 in sales in 2022
BIOLOGIC
cell and gene therapy products
cell culture
the first live drug was approved in 2017
BIOLOGIC
biologics**
large molecules**
two stages in pharma manufacturing
drug substance + drug product
monoclonal antibody
glycoproteins, high beta sheet content
molecular weight is about 150,000 daltons
quat. structure: two light chains and two heavy chains linked by SS bonds
antigen binding occurs through the varuable domain (V), at the complementary determining region (CDR)
the constant (C) domain helps determine biodistribution, plasma half-life
HUMIRA, HERCEPTIN, AVASTIN
antibody drug conjugates (ADC)
a growing class of mAb-based drugs in development
combine target specificity of mAb with efficacy of small molecule drug
can use mAb
are phosphodiester bond stable
no
RNA
linear polymer of nucleotides
nucleotide
it has a nucleobase (c G A U)
a ribose
phosphodiester bond
vaccines
inactivated
attenuated
toxoid
conjugate
subunit
can be much larger than other biologics
CART-cell therapy
these are the first living drugs
peptides
linear chains of amino acids, shorter than proteins, usually less than 50 amino acids
some secondary structure, no higher order structre
Mounjaro
a GLP-1 analog peptide
conjugated to a fatty acid via a linker
contains non-native amino acids
dosage forms for biologics
dosing is usually parenteral
commons dosage forms for biologics
solution or suspension for inj
pen or autoinjector
pre-filled syringe
lyophilized powder for reconstitution
major types of biologics are mAbs, mRNA, and oligonucleotides, vaccines, and cell therapies
