Lecture 2 Flashcards

1
Q

Bioprocess Design Flow

A

Target Molecule Development –> Bioprocess Development (Cell Cultivation -> Purification -> Formulation) –> Application

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2
Q

Questions to be answered by Design

A
  1. Requiered raw materials and ulitilies for single batch
  2. size of equipment
  3. total capital investment
  4. optimum batch size
  5. required time
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3
Q

DEFINITION Bioprozess design

A

conceptual work done prior to b uilding, expanding or retrofitting a prozess plant. TWO main activities
1. PROCESS SYTHESIS arrangement of unti operations (process steps) to produce desired product at accaptable costa nd quality
2. PROCESS ANALYSIS evaluation and comparison of different process synthesis solution

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4
Q

Investment Cost in Industry?

A

3.3 - 6.2 Million$/m^3

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5
Q

DEFINITION Process Synthesis

A

Development of a flow sheet for the recovery and purification of a biological product

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6
Q

What does an optimal process control require?

A

orthologe techniques!

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7
Q

Rule of Thumps

A
  1. Remove the largest quantity first
  2. exploit physical characteristics with the greatest difference between product and impurities
  3. use different separation bases in successive steps
  4. keep it as simple as possible
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8
Q

General classification

A
  1. Recovery and solid-liquid separation
  2. capture, isolate, concentrate
  3. Purification
  4. Polishing
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9
Q

What to keep in mind for the product classification

A
  1. Scope of application (3 triangles, from no contact to living organism to intake into human bloodstream)
  2. Side requirements (budget, location, space, time)
  3. Production system (intra- extracellular, pretreatment, modification, …)
  4. Product Class (molecular characteristics, …)
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10
Q

Steps of recovery of intracellular products?

A
  1. Cell harvesting
    a. removal of extracellular liquids (centrifuge, filtration)
  2. Cell disruption (break open host cell and release intra product)
    a. high pressure homogenizis (large capacity)
    b. beat mill
  3. Removal of cell debris (depents on size and solubility of product)
    a. soluble (centrifugal, microfiltration)
    b. in-soluble (1. seperate, 2. dissolve, 3. refold)
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11
Q

Step for recovery of extracellular product

A
  1. Removal of biomass (types: disk stack(light MO), rotary vacuum filtration(mycalial), membrane filtration(low weight), floatation(algea))
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12
Q

intermediat Recovery for soluble and in-soluble

A

soluble –> concentrate –> purify
in-soluble –> dissolve and erfold –> concentrate –> purify

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13
Q

Types of techniques to concentrate

A
  1. Ultrafiltration (protein concentration)
  2. reverse osmosis (low molecular weight
  3. evaporation (low and high molecular weight)
  4. precipitation (blodd protein, citric acid)
  5. distillation (low molecuule weight and alkohle)
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14
Q

Steps to renaturate inclusion bodies

A
  1. dissolve by strong chaotrope (zB urea)
  2. refold after diafiltration of chaotropes, dilution or chomatography, folding (thiol, high temp)
  3. dilution to minimize molecule interaction
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15
Q

Differance chaotrope and kosmotrope

A

chaotrope: lower hydrophobic effect (disrupes water water interaction)
kosmotrope: higher hydrophobic effect (stronger water water interaction)

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16
Q

final purification for biopharma and bioindustry

A

biopharma:
- high purity
- combi chroatography anf filtration steps
bioindustrial:
- medium to low purity
solvent removal
general:
- cristilation and …
- dehydration or solvent removal

17
Q

pairing of unit operations

A
  1. identify specifications for final product
  2. apply rule of thumps
  3. think about media conditions needed for process steps
18
Q

What is the process analysis based on?

A
  1. capital investment
  2. manufacturing cost
  3. enviromental cost
  4. time consumption
  5. experiance
19
Q

what is used for capital investment and manufacturing cost

A

spreatsheet and process simulator based on material and energy balances, equipment sizing
–> allows chracterizing a prozess scanrio and change it quick and accuarte wehen different data etc.

20
Q

Manufactering flow

A

Idea Generation (project screening) –> Process developement (evaluation of alternatives and common language)–> from R&D to manufacturing (facility, tech) –> manufactering (ongoing optim)

21
Q

DEFINITION Process Economics

A

Estimation of working capital investment, estimation of operating cost, analysis of profitability)

22
Q

Avarage durh developent cost

A

500- 1 bio $/ successful drug

23
Q

DEFINITION of Capital Cost estimation

A

directes fixed capital, working capital, start-up & validation cost

24
Q

Direct fixed capital (DFC)

A
  • estimated based opon total equipment purchase cost (prior projects etc)
  • function of industrial application and plant location
  • scaling law for equipment (das mit alpha 0.5-1)
  • price equimpent changes over time: CE Index
25
Q

Working Capital

A

accounts for cash that must be available for investments in on-going expenses (material, labor, utility, waste, facility overhead)

26
Q

Profitablility analysis

A

3 gleichungen
gross margin
return of investment
payback time (years)