Biotechnology
-encompasses any technique that uses living organisms in the production or modification of products
insulin, growth hormone, mab
Order Biologics from low complexity to highest complexity.
Master Cell bank
-constructed directly from a culture of a single clone of the selected clone of the selected cell line producing the protein of interest.
Working Cell bank
- normally entails thawing a single MCB ampoule, culturing of the cells, and subsequent aliquoting into multiple ampoules which are then cryopreserved
1st expansion
WCB is the ______ from the MCB.
to ensure an indefinite supply of cells that produce biopharmaceutical
What is the purpose of the MCB/WCB system?
Upstream process
-the process of manufacturing the product of interest using biological cells.
cells are grown in a starter culture and upscaled
What happens in the first 21-25 days of the upstream process?
cell metabolism is switched from growth to production, target product is produced ; 12 days
What happens in the Production stage of the upstream process? How long does it last?
create the necessary environment for cells to produce the target product
What is the main objective in the Upstream process?
stirred tank, airlift, microcarrier, membrane bioreactors
What are the four different types of bioreactors?
Stirred tank
- the most reliable and easily used bioreactor that has great scaling up potential.
capture/recovery, intermediate purification, polishing
The downstream process is composed of what ? (3)
a
Which step in the Downstream process involves the use of centrifuges, filtration, and extraction?
a) capture/recovery
b) intermediate purification
c) polishing
b
Which step in the Downstream process involves the use of size exclusion & affinity chromatography, and viral inactivation?
a) capture/recovery
b) intermediate purification
c) polishing
c
Which step in the Downstream process involves the use of simple filtration, chromatography, and volume reduction?
a) capture/recovery
b) intermediate purification
c) polishing
Capture/recovery
-The separation of the product of interest from the cell debris and the bioreactor medium
intermediate purification
-The removal of bulk contaminants, including host cell proteins and adventitious viruses, as well as any potential contaminates from other in-process materials or equipment
polishing
-The elimination of trace contaminants and impurities such as inactive or unwanted isoforms of the desired biopharmaceutical or common impurities including fragments or other chemical modifications
mAB
-antibodies that are identical because they are produced by one type of immune cell, all clones of a single parent cell
generate large quantities of ab from controlled conditions
From a pharmaceutical perspective, what is the most important advantages of using mABs?
Chinese hamster ovary
What is the most commonly used mammalian cell line?
antibody fragments
Bacterial cell culture is best suited to produce _______.
PD-L 1
-an adaptive immune resistance mechanism of tumor cells to endogenous anti-tumor activity by CD8+ T-cells
CAR-T
-chimeric antigen receptor T cells that are genetically modified to identify specific cells before being (re)introduced into the patient.
T cell receptor intracellular
CAR CD3 domain is derived from ___________ signaling domains