Podcast
Questions and Answers
Which of the following is a feature of the iCELLis bioreactor?
Which of the following is a feature of the iCELLis bioreactor?
- Compact fixed-bed with custom macrocarriers (correct)
- Continuous flow system for media
- Water cooling system for temperature control
- Integrated solar panels for energy efficiency
The BIOSTAT STR bioreactor is suitable for high density cell culture applications.
The BIOSTAT STR bioreactor is suitable for high density cell culture applications.
True (A)
Name one manufacturer of bioreactors mentioned in the content.
Name one manufacturer of bioreactors mentioned in the content.
Pall Corporation or Sartorius Stedim Biotech
The iCELLis 500 is designed for __________ scale manufacturing.
The iCELLis 500 is designed for __________ scale manufacturing.
What does the perfusion device in iCELLis bioreactor do?
What does the perfusion device in iCELLis bioreactor do?
Which of the following bioreactors is manufactured by GE Healthcare Bio-Sciences Corp?
Which of the following bioreactors is manufactured by GE Healthcare Bio-Sciences Corp?
Match the bioreactor type to its application:
Match the bioreactor type to its application:
The BIOSTAT RM can only be used for mammalian cells.
The BIOSTAT RM can only be used for mammalian cells.
The iCELLis nano bioreactor has a capacity of 70 liters.
The iCELLis nano bioreactor has a capacity of 70 liters.
Name one application of the Xcellerex XDR bioreactor.
Name one application of the Xcellerex XDR bioreactor.
List one parameter that can be controlled in bioreactors.
List one parameter that can be controlled in bioreactors.
The Xcellerex XDR has working volumes that range from ______ to ______.
The Xcellerex XDR has working volumes that range from ______ to ______.
Match the following bioreactors with their features:
Match the following bioreactors with their features:
Which parameters can be controlled in the Xcellerex XDR bioreactor?
Which parameters can be controlled in the Xcellerex XDR bioreactor?
The Xcellerex XDR bioreactor has GMP and non-GMP configurations.
The Xcellerex XDR bioreactor has GMP and non-GMP configurations.
The working volumes of BIOSTAT RM range from ______ to ______.
The working volumes of BIOSTAT RM range from ______ to ______.
What is the benefit of the advanced alarming and safety features of BIOSTAT RM?
What is the benefit of the advanced alarming and safety features of BIOSTAT RM?
Which bioreactor is known for its challenge in scale-up due to failures?
Which bioreactor is known for its challenge in scale-up due to failures?
Which of the following is considered a challenge in scaling up human cell production for regenerative therapies?
Which of the following is considered a challenge in scaling up human cell production for regenerative therapies?
Hydrodynamic shear stress is one of the culture parameters that remains unchanged during bioreactor operations.
Hydrodynamic shear stress is one of the culture parameters that remains unchanged during bioreactor operations.
Name two types of parameters that must be controlled during bioprocessing.
Name two types of parameters that must be controlled during bioprocessing.
The optimal dissolved _______ concentration is essential for cell culture in bioreactors.
The optimal dissolved _______ concentration is essential for cell culture in bioreactors.
Match the bioreactor types with their applications:
Match the bioreactor types with their applications:
What is one advantage of packed-bed reactors compared to monolayer culture?
What is one advantage of packed-bed reactors compared to monolayer culture?
Hollow fiber bioreactors are useful for both gene therapy and cell therapy applications.
Hollow fiber bioreactors are useful for both gene therapy and cell therapy applications.
What is the primary function of the Quantum Cell Culture Platform?
What is the primary function of the Quantum Cell Culture Platform?
The surface area of the hollow-fiber bioreactor is equivalent to _____ T-175 flasks.
The surface area of the hollow-fiber bioreactor is equivalent to _____ T-175 flasks.
Match the following bioreactor types with their primary features:
Match the following bioreactor types with their primary features:
What is one disadvantage of using packed-bed reactors?
What is one disadvantage of using packed-bed reactors?
The Quantum Cell Culture Platform can manage multiple systems with a single skilled operator.
The Quantum Cell Culture Platform can manage multiple systems with a single skilled operator.
Name one application of bioreactors in immunotherapy.
Name one application of bioreactors in immunotherapy.
Packed-bed reactors need to maintain __________ mass transfer for homogeneous cell density.
Packed-bed reactors need to maintain __________ mass transfer for homogeneous cell density.
What does perfusion in packed-bed reactors improve?
What does perfusion in packed-bed reactors improve?
What is one of the primary advantages of planar systems such as T-flasks?
What is one of the primary advantages of planar systems such as T-flasks?
Automated T-flask systems can perform cell counting and feeding tasks.
Automated T-flask systems can perform cell counting and feeding tasks.
Name one application of the fully automated T-flask system.
Name one application of the fully automated T-flask system.
The disadvantages of planar systems include poor surface area-to-volume ratio and ________ culture environment.
The disadvantages of planar systems include poor surface area-to-volume ratio and ________ culture environment.
Match the following features with their corresponding characteristics related to bioreactors.
Match the following features with their corresponding characteristics related to bioreactors.
Which bioreactor type provides a better mixed system compared to static systems?
Which bioreactor type provides a better mixed system compared to static systems?
Hollow-fibre bioreactors are classified as planar systems.
Hollow-fibre bioreactors are classified as planar systems.
Who manufactures the fully automated T-flask system discussed in the content?
Who manufactures the fully automated T-flask system discussed in the content?
The automated T-flask system is used for _______ expansion of cells for commercial manufacture.
The automated T-flask system is used for _______ expansion of cells for commercial manufacture.
What is a significant drawback of planar systems in bioprocessing?
What is a significant drawback of planar systems in bioprocessing?
What is a key challenge in achieving optimal environmental conditions during the scale-up of human cell production?
What is a key challenge in achieving optimal environmental conditions during the scale-up of human cell production?
Which parameter is NOT typically considered when defining scalable culture conditions for human cells?
Which parameter is NOT typically considered when defining scalable culture conditions for human cells?
In the context of regenerative therapy products, what is crucial for ensuring successful cell expansion?
In the context of regenerative therapy products, what is crucial for ensuring successful cell expansion?
Which of the following statements reflects a notable disadvantage in employing differing manufacturing paradigms for cell therapies?
Which of the following statements reflects a notable disadvantage in employing differing manufacturing paradigms for cell therapies?
What characteristic of cell culture impacts the choice of scaling technology for expansion purposes?
What characteristic of cell culture impacts the choice of scaling technology for expansion purposes?
What is the estimated dose of bone marrow stem cells required for treating graft vs. host disease?
What is the estimated dose of bone marrow stem cells required for treating graft vs. host disease?
Which variable is NOT considered when determining the culture mode for cell expansion?
Which variable is NOT considered when determining the culture mode for cell expansion?
How many estimated doses of cells for heart disease are projected per year based on a 10% market share?
How many estimated doses of cells for heart disease are projected per year based on a 10% market share?
Which critical quality attribute is NOT associated with the target product profile in cell therapy?
Which critical quality attribute is NOT associated with the target product profile in cell therapy?
Which cell type has the highest required dose for clinical indications listed?
Which cell type has the highest required dose for clinical indications listed?
What mode of cell culture utilizes variables such as culture dynamics and vessel geometries?
What mode of cell culture utilizes variables such as culture dynamics and vessel geometries?
Which of the following statements about cell manufacturing timelines is true?
Which of the following statements about cell manufacturing timelines is true?
In which culture system can multi-layer flasks be used?
In which culture system can multi-layer flasks be used?
What is the primary aim of regenerative medicine bioprocessing?
What is the primary aim of regenerative medicine bioprocessing?
Which factor is a critical quality attribute in regenerative medicine?
Which factor is a critical quality attribute in regenerative medicine?
What is a significant disadvantage of using primary cells in regenerative medicine production?
What is a significant disadvantage of using primary cells in regenerative medicine production?
In which cell manufacturing paradigm is the process of clonal cell line creation primarily involved?
In which cell manufacturing paradigm is the process of clonal cell line creation primarily involved?
What is one major difference between regenerative medicine bioprocessing and traditional biopharmaceutical production?
What is one major difference between regenerative medicine bioprocessing and traditional biopharmaceutical production?
What characteristic is essential for maintaining the critical quality attributes of living cell products during bioprocessing?
What characteristic is essential for maintaining the critical quality attributes of living cell products during bioprocessing?
What is the role of passage/sub-culture in cell expansion?
What is the role of passage/sub-culture in cell expansion?
What aspect of cell expansion presents a challenge in regenerative medicine?
What aspect of cell expansion presents a challenge in regenerative medicine?
Which type of cells primarily contains limited expansion potential?
Which type of cells primarily contains limited expansion potential?
What role do microcarriers play in cell culture for regenerative stem cells?
What role do microcarriers play in cell culture for regenerative stem cells?
Which of the following materials is not mentioned as a type of microcarrier available?
Which of the following materials is not mentioned as a type of microcarrier available?
What is a key advantage of using modified surface chemistries on microcarriers?
What is a key advantage of using modified surface chemistries on microcarriers?
How can different types of microcarriers influence cell behavior?
How can different types of microcarriers influence cell behavior?
Which property is not typically associated with microcarriers used in bioreactors?
Which property is not typically associated with microcarriers used in bioreactors?
What characteristic of microcarriers is critical for their function in regenerative stem cell culture?
What characteristic of microcarriers is critical for their function in regenerative stem cell culture?
Which of these statements is true regarding the types of microcarriers available?
Which of these statements is true regarding the types of microcarriers available?
What effect does surface chemistry modification have on microcarriers?
What effect does surface chemistry modification have on microcarriers?
Which microcarrier type is specifically named as a dextran-based option?
Which microcarrier type is specifically named as a dextran-based option?
What is a potential consequence of poor surface area-to-volume ratio in cell culture systems?
What is a potential consequence of poor surface area-to-volume ratio in cell culture systems?
Study Notes
Cell Culture Technologies
- Different bioreactor types include stirred systems, fluidized beds, and packed beds for microcarrier-based systems.
- iCELLis is the world’s first fully-integrated, single-use bioreactor; offers formats for small-scale (1L) to industrial-scale (70L) production.
- Features of iCELLis include control over temperature, pH, gas flow rates, and impeller speed, along with a unique waterfall media oxygenation system.
Bioreactor Types and Manufacturers
- BIOSTAT STR by Sartorius Stedim Biotech is a single-use bioreactor designed for high-density cell culture and various applications, including monoclonal antibody production.
- Xcellerex XDR system from GE Healthcare supports volumes from 4.5L to 2000L, automating processes for diverse cell types and provides tight temperature control.
- BIOSTAT RM is a wave-mixed, single-use bioreactor with applications in rapid pre-clinical production and shows high cell densities.
Scale-Up Challenges
- Scale-up in bioreactor processes often presents challenges such as heterogeneous culture environments and difficulties in sampling and cell removal.
- Hollow Fiber Bioreactor provides a 3D environment for cell cultures, maximizing surface area for cell growth while allowing automated processes.
- Perfusion/Packed-bed reactors are scalable but require careful monitoring to ensure homogeneity and ease of sampling.
Microcarrier/Bioreactor System Advantages
- Microcarrier systems offer high surface area-to-volume ratios and the ability to operate under different conditions, enhancing culture mixing.
- These systems support large-scale production, overcoming limitations of traditional planar culture methods, which yield heterogeneous environments.
Fully Automated Systems
- The CellBase CT system by Sartorius Stedim enables automated cell processing for clinical material production, ensuring aseptic environments and precise metrics.
Cultural Parameter Challenges
- Transitioning from static planar cultures to dynamic systems is complex due to variations in parameters like hydrodynamic shear stress and culture reagents.
- Continuous optimization of environmental conditions—including nutrient concentrations, pH, and oxygen levels—is essential to maintain effective culture.
Regulatory and Production Considerations
- The scalability of human cell cultures is crucial for regenerative therapies; production must accommodate therapeutic quantities efficiently.
- Each technology has unique advantages and disadvantages, necessitating thoughtful consideration of which cell expansion method best suits specific cell characteristics and therapeutic needs.
Summary of Current Landscape
- Significant challenges remain in cell manufacturing for regenerative therapies, particularly in scaling production.
- The selection of appropriate technology is complicated by the different requirements of autologous versus allogeneic therapies, affecting the expansion and processing of human cells.
Estimated Cell Requirements
- Heart disease treatment requires 10^8 bone marrow stem cells per dose.
- Graft versus host disease treatment needs 10^9 bone marrow stem cells per dose.
- Liver disease treatments utilize 10^9 adipose-derived stromal cells per dose.
- Heart disease estimate assumes 500,000 doses annually for 5 million patients (10% market share).
Biochemical Engineering
- Focus on translating science into societal benefits.
- Emphasizes critical quality attributes such as safety, purity, identity, and potency for target product profiles.
Current Manufacturing of Cells for RM Therapies
- Cell manufacturing processes have evolved over 40 years.
Scale-Up Technologies for Cell Expansion
- T-flasks (T25, T75, T150) are foundational systems for cell culture scalability.
- Various modes include shake culture, stirred systems, and perfused systems with specific vessel geometries and culture dynamics.
Microcarriers
- Essential for anchorage-dependent culture of regenerative stem cells.
- Provide solid matrices for cell attachment in stirred bioreactors.
- Different microcarriers (polystyrene, glass, collagen) influence cell behavior such as attachment and proliferation.
- Commercially available microcarriers include Cytodex (dextran-based), CultiSphere (collagen-based), and Solohill (polystyrene-based).
Learning Outcomes
- Grasp the distinctions between regenerative medicine bioprocessing and traditional biopharmaceutical production.
- Familiarity with various cell manufacturing paradigms and technologies.
- Ability to outline advantages and disadvantages of each production technology.
Differences between Regenerative Medicines and Traditional Bioprocesses
- Cell quality is paramount since the cell constitutes the product.
- Variations in cell types: suspension versus anchorage-dependent cells (like E. coli and CHO cells).
- Sources predominantly include primary cells with limited expansion potential, noting donor variability.
Aim of Regenerative Medicine Bioprocessing
- Design scalable, robust manufacturing processes maintaining critical quality attributes while minimizing costs.
Cell Therapy Manufacturing Paradigms
- Involves multiple stages: cell expansion, isolation from tissue/biopsy, culturing, and potential immortalization for clonal lines.
Objective of Scale-Up
- Ensure translation from small-scale to large-scale maintains optimal conditions for environmental parameters like nutrient concentration, pH, temperature, and shear sensitivity.
Process Changes
- Factors impacting production include media changes, cell density, and surface chemistry, all influencing culture environment and product quality.
Summary
- Major challenges in cell manufacture for regenerative therapies focus on scaling up production to therapeutic quantities.
- Various manufacturing paradigms exist for autologous and allogeneic therapies, each with unique pros and cons.
- Technology choice for cell expansion requires careful consideration of both cell needs and technological advantages.
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Description
Explore the core concepts of bioreactor technologies, including porosity, density, and optical properties. This quiz delves into various systems like stirred systems and fluidized bed technologies, as highlighted in Rowley et al. (2012). Test your understanding of modern bioprocessing techniques and their applications in cell expansion.
