Hosam Mohamed
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Biotechnology
-encompasses any technique that uses living organisms in the production or modification of products
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insulin, growth hormone, mab
Order Biologics from low complexity to highest complexity.
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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.
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Working Cell bank
- normally entails thawing a single MCB ampoule, culturing of the cells, and subsequent aliquoting into multiple ampoules which are then cryopreserved
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1st expansion
WCB is the ______ from the MCB.
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to ensure an indefinite supply of cells that produce biopharmaceutical
What is the purpose of the MCB/WCB system?
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Upstream process
-the process of manufacturing the product of interest using biological cells.
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cells are grown in a starter culture and upscaled
What happens in the first 21-25 days of the upstream process?
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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?
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create the necessary environment for cells to produce the target product
What is the main objective in the Upstream process?
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stirred tank, airlift, microcarrier, membrane bioreactors
What are the four different types of bioreactors?
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Stirred tank
- the most reliable and easily used bioreactor that has great scaling up potential.
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capture/recovery, intermediate purification, polishing
The downstream process is composed of what ? (3)
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a
Which step in the Downstream process involves the use of centrifuges, filtration, and extraction?
a) capture/recovery
b) intermediate purification
c) polishing
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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
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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
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Capture/recovery
-The separation of the product of interest from the cell debris and the bioreactor medium
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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
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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
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mAB
-antibodies that are identical because they are produced by one type of immune cell, all clones of a single parent cell
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generate large quantities of ab from controlled conditions
From a pharmaceutical perspective, what is the most important advantages of using mABs?
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Chinese hamster ovary
What is the most commonly used mammalian cell line?
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antibody fragments
Bacterial cell culture is best suited to produce _______.
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PD-L 1
-an adaptive immune resistance mechanism of tumor cells to endogenous anti-tumor activity by CD8+ T-cells
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CAR-T
-chimeric antigen receptor T cells that are genetically modified to identify specific cells before being (re)introduced into the patient.
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T cell receptor intracellular
CAR CD3 domain is derived from ___________ signaling domains
