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53 Cards in this Set

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process that uses complete living cells or their components to obtain desired products

Bioprocess engineering

the engineering discipline involved in designing/developing/optimizing the equipment/processes to manufacture bioprocessing products

Example Products




Fermentedproducts: beer/wine/kombucha Bioethanol

Current biopharmaceuticals

Predominantly monoclonal antibodies andother recombinant protein products

Next Generation biopharmaceuticals



Gene therapy

Stem cell therapy

Cellular immunotherapeutics

Regenerative medicine

what do next generation biopharmaceuticals target?

they target more difficult to treat and rarer diseases

Car T-cell Therapy

-example of a next generation biopharmaceutical

- t cells are taken out of body. modified, and put back into the body to target cancer

How long is the development pathway of a biopharmaceutical's bioprocessing development and manufacturing?

10-15 years

it is from pharmaceutical discovery to market

when does the bioprocessing development part actually start?

after the discovery of the drug

Molecular specific processes

process that caters specifically to the molecule you are working with

platform processes

- the universal or standard processes

- process that can be done the same from one company to another

upstream processes

- bioreactor

- harvesting (sometimes considered upstream)

- involves making the molecule, things that involve the cells

Downstream processes

- harvesting

- capture


- polishing

- concentration/buffer exchange

-freeze/ storage


getting what you care about via centrifugation and filtration.

getting the target product from the cell


for mAb, use protein A

- affinity chromatography

- considered first step of purification

purification and polishing

purification via ion exchange (including cation and anion), or chromatography

concentration/buffer exchange

done via further filtration (TFF)


tangential flow filtration


Active pharmaceutical ingredient

what is TFF used for?

1. primary recovery (harvest, cell separation)

2. to get a more concentrated volume

3. for buffer exchange (diafiltration)

TFF's role in API process

TFF helps get the active ingredient

Production time and cost using

e.coli --> yeast--> plant--> animal

e.coli doubles every 30 min

mammalian cells double every day

THEY INCREASE FROM LEFT TO RIGHT due to rate of growth

Post transitional modifications using

e.coli --> yeast--> plant--> animal)

e.coli don't require any

mammalian cells highly require them to change certain fxns


explain Glycosylation

depending on where and what glycosylations done, the function of the antibody is changed

list glycosylation modifications

stability, solubility, half life, protein folding

cell line development process

ex: transfecting host cell with protein of interest, then attach the protein of interest with selection marker. selects successfully transfected cells with high copy number.

engineer cells to produce protien product/ of interest

media selection

sugars, amino acids, fatty acids, lipids, vitamin, ph buffers, salt

needed for cell growth/survival

bioreactor design

1. put in media at appropriate temperature (cooling water or heating jacket system to control )

2.put in cells

3. sparge in air so cells have O2

4. air is towards agitator, therefore it spins

5. spins and breaks down bubbles

-- baffles = make the flow turbulent

-- inlet/outlet ports: where you can put things in/out

--outlet gas goes out

medium supplements

serum, hydrolysate, phospholipids, growth factors

Batch mode of bioreactor operation


media put into bioreactor to grow cells

fed- batch of bioreactor operation

media and food (glucose) put into bioreactor

* feeding it while the process of growth

Continous (chemostat) mode of bioreactor operation

media put into the bioreactor, then take out media and send to harvest


has to do with bacteria and yeast growth

bioreactor is for?

growing mammalian cells

continuous ( perfusion) mode of bioreactor operation

media put into the bioreactor, then take out media but ALSO separating out cells and putting the cells back in

-- to achieve high cell densities and more product out

which mode of bioreactor operation an industry standard for Monoclonal Ab production?


scale up of bioreactors

to make lots of bioreactors. from lab/small scale to a commercial scale

- need to preserve geometric, dynamic, and kinematic similarity in order to preserve optimal physiological conditions (growth, cell density, productivity)

scale up criteria

1. constant kLa (related to O2 transfer)

2. constant impeller tip speed

3. constant P/V (power/unit volume)

4. constant mixing time

* the apporach chosen depends on variables important to particular process


for cell growth and metabolism

most cells require pH conditions in the range: 7.2 - 7.4


for cell growth and metabolism

temp for most mammalian cells: 37 C

Oxygen transfer

for cell growth and metabolism

need O2 to go from air bubbles put into bioreactor --> to the media so that it can then go to the cells


through cell culture process, the cells release metabolites and they often become toxic

- remove these wastes and metabolites out to remove the toxicity

why is O2 continuously supplied?

O2 solubility in cell media is super low. which is bad bc need it to diffuse through media to get to cell

O2 into media

O2 in air bubble. bubble has a boundary layer. hard for it to get out and into the media.

need enough O2 for cells

kLa coefficient= how well O2 goes from air bubbles to media

Viral clearance/inactivation operations

( in purified protein products )

solvent/detergent mix and low pH hold

causes damages to the envelope part of the virus

viral clearance / inactivation for non-envelope viruses from protein prdts

Nano- filtration


critical quality attributes

- physical, chemical, biological or microbiological properties that should be within an appropriate limit, range, or distribution to ensure the desired product quality

protein drug CQAs

pH, DNA, sterility, high and low molecular weight spaces, acidic and basic species, protein concentration


quality by design

- scientific, risk-based, holistic and proactive approach to pharmaceutical development.

- design effort from pdt conception to commercialization

- understanding of how pdt attributes and process relates to pdt performance

six sigma

measure process performance quality in terms of variability

expects 3.4 defective features per million opportunities

the higher the sigma value

the lower the defects


- not true generics

- not bioequivalents

- not biobetter

- not biologics (not small molecule equivalent to a biologic pdt)

-not better nor worse BUT SIMILAR


has bulk drug substance. Liquid and protein. It has API. stored in buffer