The document discusses bioprocess development for animal cell culture. It highlights that screening phases are important but have reproducibility issues when scaling up. The HexaScreen and HexaBatch systems aim to address these issues by providing (1) an automated and controlled multi-vessel screening platform, (2) low volume bioreactors to better mimic industrial scales, and (3) monitoring of key parameters like cell growth, pH and oxygen to improve screening accuracy and translation to later phases. This helps streamline bioprocess optimization from initial screening through production.
This presentation covers the introduction to Insect Cell Culture. Also covers its general information about cell culture practices followed in the lab. It covers culture media, the source of cells for culture and examples of the cell line with their culture conditions.
This presentation covers the introduction to Insect Cell Culture. Also covers its general information about cell culture practices followed in the lab. It covers culture media, the source of cells for culture and examples of the cell line with their culture conditions.
Contains everything about cell culture and cell culture laboratory. The data has been collected from various sources and piled up to make this presentation.
Bioreactors are essential in tissue
engineering, not only because they provide an
in vitro environment mimicking in vivo conditions
for the growth of tissue substitutes, but also
because they enable systematic studies of the
responses of living tissues to various mechanical
and biochemical cues.
Equipments used , types of culture and media, subculturing, secondary culture, finite & continuous cell lines, cryopreservation and applications of cell culture
This presentation contains all the material regarding History of animal cell culture and different methods of organ and tissue culture.Hope it will be helpful..
Contains everything about cell culture and cell culture laboratory. The data has been collected from various sources and piled up to make this presentation.
Bioreactors are essential in tissue
engineering, not only because they provide an
in vitro environment mimicking in vivo conditions
for the growth of tissue substitutes, but also
because they enable systematic studies of the
responses of living tissues to various mechanical
and biochemical cues.
Equipments used , types of culture and media, subculturing, secondary culture, finite & continuous cell lines, cryopreservation and applications of cell culture
This presentation contains all the material regarding History of animal cell culture and different methods of organ and tissue culture.Hope it will be helpful..
Regularly examining the morphology of the cells in culture (i.e., their shape and appearance) is essential for successful cell culture experiments. In addition to confirming the healthy status of your cells, inspecting the cells by eye and a microscope each time they are handled will allow you to detect any signs of contamination early on and to contain it before it spreads to other cultures around the laboratory.
Learn how to inspect the cell morphology of the cells in a cell culture in this brief presentation with visual cell culture examples.
More best practices can be found in the Gibco Cell Culture Basics handbook http://owl.li/dgXMU
Bioreactors for animal cell suspension cultureGrace Felciya
1. Types of culture
2. Techniques of cultivating animal cell
3. suspension culture/ Non anchorage dependent
4. Bioreactor consideration
5. Requirements of Bioreactor
6. Reactors used in cultivation
Getting Biopharmaceutical Production Processes Right the First TimeKBI Biopharma
Strategies for rapid acceleration of cell line, upstream and downstream process development. A presentation by Ying Huang, Ph.D., Associate Director of Cell Line Development at KBI Biopharma. Presented at World Orphan Drug Congress. Washington DC. (2014)
Introduction to Bioprocessing Sample SlidesPeteDeOlympio
Introduction to Bioprocessing
Monday, January 19, 8:30 AM-5:30 PM – Tuesday, January 20, 8:30 AM-12:30 PM
View sample slides
CHI’s Introduction to Bioprocessing training seminar offers a comprehensive survey of the steps needed to produce today’s complex biopharmaceuticals, from early development through commercial. The seminar begins with a brief introduction to biologic drugs and the aspects of protein science that drive the intricate progression of analytical and process steps that follows. We then step through the stages of bioprocessing, beginning with the development of cell lines and ending at the packaging of a finished drug product. The seminar also explores emerging process technologies, facility design considerations and the regulatory and quality standards that govern our industry throughout development. The important roles played by the analytical and formulation in developing and gaining approval for a biopharmaceutical are also examined. This 1.5-day class is directed to attendees working in any aspect of industry, including scientific, technical, business, marketing or support functions, who would benefit from a detailed overview of this field.
For full details visit chi-peptalk.com/peptalk_content.aspx?id=140088&libID=140059
Promises and Challenges of Manufacturing and Testing Viral Producer Cell LinesMilliporeSigma
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Promises and Challenges of Manufacturing and Testing Viral Producer Cell LinesMerck Life Sciences
To date, manufacturing of lentivirus (LV) vectors for gene therapy commonly relies on transient transfection of adherent HEK293 cells. This method is costly, time-consuming, difficult to scale-up and poorly reproducible, rendering large-scale applicability to fulfill increasing demand of LV in clinical pipelines cumbersome. The use of suspension-adapted transient producer cell lines for LV production has overcome some of these challenges. Furthermore, successful creation of stable producer cell lines would allow creation of master and working cell banks easily amenable to commercial production. The ideal producer cell lines should demonstrate stability in growth and gene expression, and be easily adaptable to chemically defined culture conditions and optimized for high-titer virus production. The availability of more robust producer cell lines thus represents an important scalable first step towards manufacturing processes that are conducive to large-scale production. Ultimately, these producer cell lines must be screened to satisfy various biosafety and regulatory implications.
In this webinar, you will learn:
• Process development for transient and stable producer cell lines
• Screening of cellular gene targets via CRISPR to improve LV production from producer cell lines
• cGMP and Regulatory readiness: Cell line characterization and release testing through BioReliance® global service offering
Demonstrating Process Scalability with Robust and Turnkey PlatformsMerck Life Sciences
Upstream bioreactor process development and scale-up is a time-consuming step in recombinant protein production. Variability in the recombinant cell, cell culture media and bioreactor vessel contributes to the number of studies required to obtain a stable, productive, and scalable process. In our laboratory, we set out to develop a robust, turnkey platform that includes DNA vectors, modified cell lines, chemically defined cell culture media and single-use bioreactors. Here we demonstrate process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale flasks through bench-scale bioreactors and up to 50 L pilot scale bioreactor systems. While challenges typical of process scale-up were present, we consistently achieved the desired level of process performance across the different scales with minimal process optimization due to the robustness of the complete solution.
In this webinar, you will learn about:
- Demonstrating the process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale up to 50 L pilot scale.
- Achieving the desired level of process performance across the different scales.
Demonstrating Process Scalability with Robust and Turnkey PlatformsMilliporeSigma
Upstream bioreactor process development and scale-up is a time-consuming step in recombinant protein production. Variability in the recombinant cell, cell culture media and bioreactor vessel contributes to the number of studies required to obtain a stable, productive, and scalable process. In our laboratory, we set out to develop a robust, turnkey platform that includes DNA vectors, modified cell lines, chemically defined cell culture media and single-use bioreactors. Here we demonstrate process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale flasks through bench-scale bioreactors and up to 50 L pilot scale bioreactor systems. While challenges typical of process scale-up were present, we consistently achieved the desired level of process performance across the different scales with minimal process optimization due to the robustness of the complete solution.
In this webinar, you will learn about:
- Demonstrating the process development and scale-up of a recombinant CHOZN® GS clone in EX-CELL® Advanced™ cell culture media from small-scale up to 50 L pilot scale.
- Achieving the desired level of process performance across the different scales.
Scalability of Cell Culture Processes in Single-use Bioreactors using Differe...KBI Biopharma
Niket Bubna, Cameron T. Phillips, Sigma S. Mostafa and AbhinavA. Shukla. KBI Biopharma, Durham, NC
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#acsSanFran • www.acs.org/SanFran2017
Risk Mitigation in Cell Line Development: Regulatory Considerations and Impac...MilliporeSigma
In this webinar, you will learn about:
- Risk assessment approaches in upstream process development
- How early cell line development stage is linked to subsequent steps in the bioprocess to assure the quality of the final product
- Benefits of having a completely chemically defined cell line development process
Detailed description:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (Chemistry, manufacturing, and controls).
In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform.
Risk Mitigation in Cell Line Development: Regulatory Considerations and Impac...Merck Life Sciences
In this webinar, you will learn about:
- Risk assessment approaches in upstream process development
- How early cell line development stage is linked to subsequent steps in the bioprocess to assure the quality of the final product
- Benefits of having a completely chemically defined cell line development process
Detailed description:
Chinese Hamster Ovary (CHO) cells are the preferred host for producing biotherapeutics where cell line development (CLD) is the foundation of the bioprocess. CLD processes are expected to be robust while meeting a myriad of regulatory requirements. The choice of production cell line, culture conditions, and having a chemically defined (CD) CLD process by using CD cloning media can impact the subsequent measures for the CMC (Chemistry, manufacturing, and controls).
In this presentation, we will discuss these choices and their impacts on subsequent bioprocess and CMC testing required by regulations and the benefits of incorporating CD cloning media into the CHOZN® expression platform.
Many important bio-products are produced by means of fermentation where microbial, plant or animal cells are employed to produce them as their metabolites.
Next Generation Recombinant Protein ManufacturingKBI Biopharma
Next Generation Processes: What Model Works Best to Manufacture Recombinant Proteins in Asia?
BioPharma Asia 2017
Suntec Convention Center. Singapore, March 22, 2017
Thomas Jung, M.S. Vice President, Business Development
KBI Biopharma Inc.
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Javier Amayra - Biotechnological Screening in Animal Cell Culture
1. HexaScreen®
Biotechnological Screening in Animal Cell Culture
Equipment to reduce required time &
costs for bioprocess development
EXPOQUIMIA 2011
www.telstar-lifesciences.com
2. The Team
•Cell Culture
•Manufacturing
•Bioreactors
•Marketing & Sales
+ • Measurement Systems
•Internationalization
+ +
•Biocompatible materials
www.telstar-lifesciences.com
4. Animal Cell Culture Bioprocesses
The potential of animal cell culture arises from the capability of this type of
cells to carry out complex post-translational modifications providing proteins
with the required biological activity to be used for therapeutical and
diagnostic applications
CHO (Chineese Hamster Ovary)
NSO (mouse mieloma)
BHK (Baby Hamster Kidney)
HEK (Human Embryo Kidney)
PER.C6 (Human Retinal Cells)
MDCK (Madin Darby Canine Kidney)
Sf9 (insect cells, Spodoptera frugiperda)
www.telstar-lifesciences.com
5. Bioprocess Development: Animal Cell Culture
”The optimization of the bioprocess is specially important for animal cell culture”
– Less Cellular Concentration than Bacterium and Yeast:
• Bacterium and Yeast cultures: [X]f ≈ 109 cells/ml
• Animal cell cultures: [X]f ≈ 106 cells/ml
If Ps=ct, we have 1000 times more product
with bacterium or yeast than with animal cells
– More expensive & complex process:
• Culture media:
– Bacterium and Yeast cell culture: Simple undefined mediums
containing only salts (usually NaCl) and carbon & nitrogen sources
(usually within yeast extract and tryptone).
– Animal cell culture: Rich & complex mediums containing salts,
carbon & nitrogen sources, but also complements (AA, vitamins,
trace elements…) and serums (FCB, FBS…).
• Easier to be contaminated:
– Bacteria, yeast, mycoplasma or cross contamination.
– Specific challenges for animal cell culture: slow growth and specific
production rates, cell sensitivity (shear stress, nutrient limitation,
metabolite accumulation..). www.telstar-lifesciences.com
6. Bioprocess Development: Main Steps
Genetic Engineering Culture Conditions Operational Conditions
Best Clones: Best Conditions: Optimal Process:
Specific Productivity [X] [X]
Growth rate Death times
www.hexascreen.com
from F. Wurm. Nat. Biotechnol., vol. 22:1393-1398 (2004)
7. Multiple aspects need to be optimized to establish optimal
and profitable production processes
Purification
process
Culture Fisico-chemical
medium parameters
PROCESS
Clonal OPTIMIZATION Operation
selection strategy
Cell Process
line Scale-up control
GMP
production
High cell concentration, high specific productivity, maintain product quality
www.telstar-lifesciences.com
8. Bioprocess Development: Phases
• PHASE I: Initial screening IMPORTANT!!!
1. Cell line selection (bacterium, yeast, animal cell…)
2. Cell modification (genetic engineering) Check the
7/8 3. Clonal activity selection activity of the
clones
Select which cells are producing the protein target protein in all
4. Protein target characterization:
phases
Measurement of the protein activity
• PHASE II: Advanced screening
1. Clonal growth selection (select which cells grow faster…)
1/2 2. Culture medium composition: serum, glutamine, glucose…
clones
3. Initial cell concentration.
4. Effects of stirring, [O2] and other culture conditions
5. Needs of the cell culture adaptation (ex: from adherent to suspension)
• PHASE III: Lab scale production
1. Scale-up the advanced screening optimum conditions
2. Purification process
3. Type of Bioreactor (Batch, Fed-Batch, Perfusion)
• PHASE IV: Pilot Plant and Industrial scale production
1. Scale-up the lab scale optimum production conditions
www.telstar-lifesciences.com
9. Screening Bioreactors: Differences
– Reproducibility problems when scaling up from usual
screening phases into lab or pilot & production plant
scales due to:
• Homogeneity: Non agitated systems can produce cells or nutrient
Reproducibility
accumulations giving not representative and impossible to repeat
problems experiments.
• [O2] limitations: Can produce a decrease of the cell culture growth
velocity, metabolic differences or stopping the cellular cycle leading to an
unreal productivity determination (higher or lower).
– Lack of probes: few knowledge of the main cellular
growth parameters : cell concentration, pH & pO2.
– Lack of automatization: human manipulation is highly
needed.
– Current screening agitated systems (spinner flasks)
Cost and time characteristics include high volumes and post-
issues experiment treatments.
www.telstar-lifesciences.com
11. Bioprocess Development: Phases
Bioprocess development for a biotechnology product
requires a number of steps
Scale-up Methodology: Laboratory to Pilot to
Industrial
Initial HEXABATCH
Screening
Advanced
Screening Lab scale
Since Biotechnological Processes are not
completely known, the transition from bench to Pilot Plant Production Plant
final volume is done step by step. www.telstar-lifesciences.com
12. Screening: HexaBatch®Design Criteria
– Simultaneous multiple experiment capability.
– Low minibioreactor volumes (10-15 mL), but not too low
to allow cell culture similarities with lab scale
bioreactors.
– Agitation requirement to allow system homogeneity, but
without upsetting cell viability.
– Parts in contact with cells must be manufactured with
single use biocompatible plastic (no contamination,…).
– Cell growth (optical density), pH and dissolved oxygen
monitoring via non invasive probes.
www.hexascreen.com
13. HexaScreen®: HexaBatch Features
Initial/Advanced Pilot Plant
HexaBatch
Screening / Industry
Stirred & O2 fed Culture Stirred Culture
Equipment used & Stationary Culture
System to allow Systems:
environment Systems: Heterogeneous
homogeneity Homogeneous
Multiple experiments run
simultaneously to
Unique cell
Methodology Multiple experiments decrease the time
culture process
required for the
screening phase
From 2 to
10-15 ml (bench top
Vessel size Micro liters and milliliters thousands of
scale)
liters
pH, pO2 and OD (cell
Discontinuous and Continuous
Process control concentration) on-line
manual and monitored
monitoring
Disposable bioreactor
made of sterile
Asepsis Difficult / uncontrolled Necessary
biocompatible plastic
material
www.telstar-lifesciences.com
14. HexaScreen®: HexaBatch Elements
HexaBatch version consists in two differentiated parts,
the 6-minibioreactors’ plate and the workstation with a
computer/software .
– Single use Minibioreactors’ Plate. Previously sterilized
inside a plastic bag, includes 6 individual vessels equipped
with gas filters, one septum for inoculation, miniaturized
ports for probe’s allocation and a magnetic actuator for
stirring.
– Workstation. Contains the chamber where the
minibioreactors’s plate remains during its culture, while
maintaining optimal agitation & temperature (common),
sterility, providing individual aeration and acquiring pH, DO
and OD data. WorkStation is controlled via software.
www.telstar-lifesciences.com
15. HexaBatch: Minibioreactor plate characteristics
1-. Optical port for OD and pH measurements. 2
3 4
1
2-. Gas filters (inlet and outlet).
3-. Optical port for DO measurements via
fluorescence.
4-. Septum for cell inoculation.
5-. Low shear magnetic pendular
agitation (optimal for animal cell).
6-. Thermostated general bath.
8
7-. Vessel liquid volume: 10-15 ml.
8-. Biocompatible and disposable plastic, 7 6 5
sterile provided. Possible plasma treatment
to promote cell adherence / non-
adherence.
www.telstar-lifesciences.com
18. HexaBatch: Variables, Controls & Monitoring
Variable Control Monitoring Information
Aeration Time Controlled No No
Agitation Set-point controlled No No
Vessel
Set-point controlled Monitored System functionality
Temperature
Gas & Filters Filters functionality –
Set-point controlled Monitored
Temperature Avoids evaporation
Monitored and Cell density information,
Optical Density Free evolution
correlated related to total cells
Dissolved Free evolution Oxygen concentration,
Monitored
Oxygen (constant aeration) related to alive cells
Cell activity information,
pH Free evolution Monitored
related to alive cells
www.telstar-lifesciences.com
19. HexaBatch: Software Specifications
HexaScreen®’s control & acquisition program runs on a Windows
platform and will guide the user, as a wizard, through the processes of
workstation’s configuration, calibration and data acquisition.
General specifications
• Automatic processes:
– Workstation’s configuration
– Thermal stabilization
– Oxygen calibration
– Optical calibration
– Data acquisition (minibioreactors’ behaviour monitoring graphs)
• Additional tasks:
– Create new or edit already existing experiment set-ups
– Create user defined graphs
– Create reports
– Export reports to EXCEL, PDF and HTML files
www.hexascreen.com
20. HexaBatch: Advantages & Benefits
Features Advantages Benefits
- Stirring, gas exchange and oxygen supply are - Focused.
Specially designed for animal cell
specially designed for handling animal cell - Suitable for both suspension and
culture.
culture. adherent cultures.
- Reducing working volume means less
Benchtop Scale:
development costs in medium, cell culture, - Lower operation cost.
Small Volumes from 10 to 15 ml”.
enzymes…
Parallel bioreactor system: - Less time required to achieve final results - Faster time to market.
“6 multiple parallel experiments - Reproducible results: statistic data can be - Save time.
for device”. obtained from replicated experiments. - Faster product development cycles.
- Precision & control over all
- Real-time kinetic information:
experimentation.
Automated on-line cell concentration (OD), DO & pH.
- Lower labour and time-consuming in
measurements. - No off-line control processes required.
order to invest in other valuable
- No maintenance required during experiment.
tasks.
- No post-experiments treatments. - Save money & time.
Single use.
- Avoid possible cross-contaminations. - Easier experiment validations.
Easy to use. - No expert personal required. - Less effort required.
Convenient. - Easier scale up to lab-size reactors. - Optimized culture parameters.
- Save automatically the data acquired from all - Control on all acquisition
PC controlled. the experiments done giving a comprehensive experiment data.
documentation. - Possibility to do final reports easier.
www.hexascreen.com
21. HexaBatch: Applications & Cell Lines Cultured
Applications Examples Cell Lines Cultured
- Adherence and suspension lines. Suspension:
Cellular screening.
- Clone selection.
- Hybridoma.
- Growth parameters measurements (cell
Cellular characterization. - Genetically modified hybridoma.
density and cell activity).
- CHO cells (adapted).
Cellular adaptation. - Adherent to suspension. - HEK (adapted)
Adherent:
Medium definition and - Commercial medium comparison.
optimization. - Medium’s components definition. - Vero cells.
- New drugs tests. - Ovine Mesenchymal Stem Cells.
Cellular tests. - Toxicity tests.
- Apoptosis tests. - CHO.
- HEK.
- Initial cellular concentration, culture
Process optimization.
conditions…
www.hexascreen.com
22. Advantages of single-use technology
Fast setup.
No need for Cleaning.
No risk of cross-contamination.
Minimizes utility requirements.
Minimizes validation.
Minimizes space floor.
Minimizes labor.
Minimizes engineering design.
Reduces COGS.
Minimizes maintenance.
Environmentally friendly:
Use for generate electrical power by incineration.
Estimated savings in WFI at over 80%.
Estimated 72% saving in electricity compared to conventional
manufacturing facility.
www.hexascreen.com
24. Systems comparison for screening
• Systems to evaluate:
• HexaBatch On-line measurements
• 1L glass Bioreactor
• T-flasks for suspension cell cultures
Off-line measurements
• T-flasks for adherent cell cultures
www.telstar-lifesciences.com
25. HexaBatch Case Study: Conditions
• Case Study parameters:
• Number of conditions: 2
• Number of repetitions: 3
• Total number of cultures: 6
• Batch culture time: 3 days
• Cell line: CHO
• Culture media price (CDCHO): 103,52 €/L
• Qualified personnel costs: 30 €/hour
• It is assumed that there is only a one-liter bioreactor, so steps of the
experiment are performed sequentially.
• For off-line measurements (T-Flasks), only one sample is taken each
day, with a total of 3 cell concentration measurements during culture.
(no metabolites concentration measured)
www.hexascreen.com
26. HexaBatch Case Study: Time Analysis
Fins a Fin
5040
699 Total personnel cost (€)
Inoculum Scale-up time 19
totals Bioreactor set-up time operation cost (€)
tot
45 43 days Total sterilization, CIP, calibration, post-exp. cleaning)
(Set-up,
bioreactor
40 Total time
Culture culture medium cost (€)
Experimental time (days)
35
18
30
25 36 days
20
18
15
10
5 days
5 4 days 4 days
7 3
3 3
1 1 2
0
1 HexaBatch 1L Bioreactor T-flasks T-flasks (adherent cell)
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27. HexaBatch Case Study: Costs Analysis
Fins a
Fins a a
Fins5040
5040 699 Total personnel cost (€)
Fins a
Fins a a
Fins1960
1960
699 totals
5040
699 Total personnel cost (€)
Total personnel cost (€) 1960totals
totals Total bioreactor operation cost (€) totals
Fins a totals Total bioreactor operation cost (€)
Total bioreactor operation cost (€)
Total culture medium cost (€)
totals
Fi
2.520 € Total culture medium cost (€)
Total culture medium cost (€)
5040
2500699
Total personnel cost (€)
Personnel costs 1
(staff hours x costs/hour)
totals Lab material costs
to
Total bioreactor operation cost (€)
(Single-use plate costs + T-flask costs for scale-up)
Coste de un experimento (€)
Total experimental cost (€)
ExperimentTotal experimental cost (€)
Total experimental cost (€)
Total experimental cost (€)
Culture medium costs
Total culture medium cost (€)
2000
183 €
costs (€)
22,5 1800 161 €
22,5
22,5
1500
507 €
1000 151 150
151
151 150
150
21
12
500 978
12
12
9 4 7 21
99 699 44 77 21
21
21 12
0
1 HexaBatch 1L Bioreactor T-flasks T-flasks (adherent cell)
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28. HexaBatch Case Study: Manipulation Times
Qualified Personnel Manipulation Time (hours)
60 hours
60
50
40
30
20 33 hours
10
5 hours
45 min
0
1 HexaBatch 1L Bioreactor T-flasks T-flasks (adherent cell)
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29. HexaBatch Results: On-line Optical Density
- Hexabatch gives one on-line OD measurement every five minutes vs
just one/two per day in the case of T-flasks.
Total cells
Final cell concentration
Off-line
Measurements
(T-FLASK)
, tdup
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30. HexaBatch Results: On-line pH Measurements
Gives
information
, tdup (indirect)
about cell
activity
Faster response than OD
(no death cells interaction)
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32. Conclusion: HexaBatch system
HexaBatch System
=
1L bioreactor specifications
+
T-Flasks cheap and fast experimentation
• Technological advantages from a bioreactor
• System’s homogeneity: stirring and aeration
• On-line process monitoring (pH, DO, OD)
• Easy maintenance of asepsis
• T-flask experiment price, speed and flexibility
• Working volume at ml scale
• Multiple experiment capability
• Minimal needs on qualified personnel
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33. HexaScreen Applications: Index
1. Pharmacokinetic Tests.
2. Clone Comparison.
3. Media Comparison.
4. Inoculum Concentration.
5. Adaption to Suspension Cultures.
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34. Drug Functional Tests: Pharmacokinetics
Antibiotic effect in cell cultures
Functional Tests
Activity profiles
More advantages to perform functional tests
in cell cultures than in animals:
- Faster results
- Ethical issues www.hexascreen.com
35. Advanced Screening: Clone Comparison
Chose the best clone in terms of:
- Cell growth rates.
- Cell activity.
- Productivity at different sample times activity
Growth
rates
activity
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36. Advanced Screening: Media Comparison
Medium
component
• Best growth medium depletion
• Time of action:
- Fed-Batch start point.
- Infection.
- Product recovery.
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37. Advanced Screening: Inoculum Concentration
Cell concentration profiles
obtained from pH profiles
(related to cell activity)
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38. Advanced Screening: Suspension Adaption
Cell concentration control along passages
Control over adaption process
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39. GRACIAS POR SU ATENCIÓN:
JAVIER AMAYRA: jamayra@hexascreen.com General Manager
HexaScreen Culture Technologies S.L.
Edifici Eureka, P1M1.2
Parc de Recerca de la Universidad Autónoma de Barcelona (UAB)
08193 Cerdanyola del Vallès (Barcelona)
www.hexascreen.com