Bioreactor Technologies Overview
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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.

    True

    Name one manufacturer of bioreactors mentioned in the content.

    Pall Corporation or Sartorius Stedim Biotech

    The iCELLis 500 is designed for __________ scale manufacturing.

    <p>industrial</p> Signup and view all the answers

    What does the perfusion device in iCELLis bioreactor do?

    <p>Reduces process development time</p> Signup and view all the answers

    Which of the following bioreactors is manufactured by GE Healthcare Bio-Sciences Corp?

    <p>Xcellerex XDR</p> Signup and view all the answers

    Match the bioreactor type to its application:

    <p>iCELLis = Feasibility studies and small-scale production BIOSTAT STR = Monoclonal antibody production Fluidized bed = Industrial scale manufacturing Stirred systems = Research and process development</p> Signup and view all the answers

    The BIOSTAT RM can only be used for mammalian cells.

    <p>False</p> Signup and view all the answers

    The iCELLis nano bioreactor has a capacity of 70 liters.

    <p>False</p> Signup and view all the answers

    Name one application of the Xcellerex XDR bioreactor.

    <p>Cultivation of CHO cells, Vero cells, MDCK cells, or microbial applications such as E.coli.</p> Signup and view all the answers

    List one parameter that can be controlled in bioreactors.

    <p>Temperature, pH, Gas Flow Rates, Impeller Speed, or Dissolved Oxygen</p> Signup and view all the answers

    The Xcellerex XDR has working volumes that range from ______ to ______.

    <p>4.5L, 2000L</p> Signup and view all the answers

    Match the following bioreactors with their features:

    <p>Xcellerex XDR = Single use bioreactors with automated control BIOSTAT RM = Full GMP compliance and individual control of two bags</p> Signup and view all the answers

    Which parameters can be controlled in the Xcellerex XDR bioreactor?

    <p>Temperature, pH, Gas Flow Rates, Impeller Speed, Dissolved Carbon dioxide, and DO</p> Signup and view all the answers

    The Xcellerex XDR bioreactor has GMP and non-GMP configurations.

    <p>True</p> Signup and view all the answers

    The working volumes of BIOSTAT RM range from ______ to ______.

    <p>100 ml, 100 L</p> Signup and view all the answers

    What is the benefit of the advanced alarming and safety features of BIOSTAT RM?

    <p>They ensure safe cultivation.</p> Signup and view all the answers

    Which bioreactor is known for its challenge in scale-up due to failures?

    <p>Both bioreactors face scale-up challenges</p> Signup and view all the answers

    Which of the following is considered a challenge in scaling up human cell production for regenerative therapies?

    <p>All of the above</p> Signup and view all the answers

    Hydrodynamic shear stress is one of the culture parameters that remains unchanged during bioreactor operations.

    <p>False</p> Signup and view all the answers

    Name two types of parameters that must be controlled during bioprocessing.

    <p>Nutrient concentrations, pH</p> Signup and view all the answers

    The optimal dissolved _______ concentration is essential for cell culture in bioreactors.

    <p>oxygen</p> Signup and view all the answers

    Match the bioreactor types with their applications:

    <p>Stirred-tank bioreactor = Used for large-scale cell culture Microbial fermenter = Used for fermentation processes Fixed bed bioreactor = Used for immobilized cell culture Taylor-Couette bioreactor = Used for studying shear effects on cells</p> Signup and view all the answers

    What is one advantage of packed-bed reactors compared to monolayer culture?

    <p>Better scalability</p> Signup and view all the answers

    Hollow fiber bioreactors are useful for both gene therapy and cell therapy applications.

    <p>True</p> Signup and view all the answers

    What is the primary function of the Quantum Cell Culture Platform?

    <p>Automated cell seeding, reagent addition, feeding, and harvesting</p> Signup and view all the answers

    The surface area of the hollow-fiber bioreactor is equivalent to _____ T-175 flasks.

    <p>120</p> Signup and view all the answers

    Match the following bioreactor types with their primary features:

    <p>Hollow Fiber Bioreactor = Maximizes surface area-to-volume ratio Packed-bed Reactor = Online monitoring and control Stirred-tank Bioreactor = Well-mixed culture environment Microcarrier System = High surface area to volume ratio</p> Signup and view all the answers

    What is one disadvantage of using packed-bed reactors?

    <p>Difficult sampling</p> Signup and view all the answers

    The Quantum Cell Culture Platform can manage multiple systems with a single skilled operator.

    <p>True</p> Signup and view all the answers

    Name one application of bioreactors in immunotherapy.

    <p>T-Cell Expansion</p> Signup and view all the answers

    Packed-bed reactors need to maintain __________ mass transfer for homogeneous cell density.

    <p>homogeneous axial and radial</p> Signup and view all the answers

    What does perfusion in packed-bed reactors improve?

    <p>Cell growth performance</p> Signup and view all the answers

    What is one of the primary advantages of planar systems such as T-flasks?

    <p>Well accepted and well understood method</p> Signup and view all the answers

    Automated T-flask systems can perform cell counting and feeding tasks.

    <p>True</p> Signup and view all the answers

    Name one application of the fully automated T-flask system.

    <p>Production of clinical material for Phase II and Phase III trials</p> Signup and view all the answers

    The disadvantages of planar systems include poor surface area-to-volume ratio and ________ culture environment.

    <p>heterogeneous</p> Signup and view all the answers

    Match the following features with their corresponding characteristics related to bioreactors.

    <p>Aseptic processing environment = Prevents contamination during cell culture Automated microscopy = Allows for real-time monitoring of cells Precise counting = Ensures accurate data for cell viability Parallel processing = Handles multiple patient products simultaneously</p> Signup and view all the answers

    Which bioreactor type provides a better mixed system compared to static systems?

    <p>Roller bottles</p> Signup and view all the answers

    Hollow-fibre bioreactors are classified as planar systems.

    <p>False</p> Signup and view all the answers

    Who manufactures the fully automated T-flask system discussed in the content?

    <p>Sartorius Stedim Biotech</p> Signup and view all the answers

    The automated T-flask system is used for _______ expansion of cells for commercial manufacture.

    <p>Ex vivo</p> Signup and view all the answers

    What is a significant drawback of planar systems in bioprocessing?

    <p>They are difficult to change in operation mode</p> Signup and view all the answers

    What is a key challenge in achieving optimal environmental conditions during the scale-up of human cell production?

    <p>Controlling hydrodynamic shear stress during processing</p> Signup and view all the answers

    Which parameter is NOT typically considered when defining scalable culture conditions for human cells?

    <p>Cellular genetic modification methods</p> Signup and view all the answers

    In the context of regenerative therapy products, what is crucial for ensuring successful cell expansion?

    <p>Maintaining optimal dissolved oxygen levels</p> Signup and view all the answers

    Which of the following statements reflects a notable disadvantage in employing differing manufacturing paradigms for cell therapies?

    <p>They can lead to variable therapeutic outcomes.</p> Signup and view all the answers

    What characteristic of cell culture impacts the choice of scaling technology for expansion purposes?

    <p>Cell density and surface chemistry</p> Signup and view all the answers

    What is the estimated dose of bone marrow stem cells required for treating graft vs. host disease?

    <p>10^9 cells</p> Signup and view all the answers

    Which variable is NOT considered when determining the culture mode for cell expansion?

    <p>Temperature stability</p> Signup and view all the answers

    How many estimated doses of cells for heart disease are projected per year based on a 10% market share?

    <p>500,000 doses</p> Signup and view all the answers

    Which critical quality attribute is NOT associated with the target product profile in cell therapy?

    <p>Cost-effectiveness</p> Signup and view all the answers

    Which cell type has the highest required dose for clinical indications listed?

    <p>Bone marrow stem cells for graft vs. host disease</p> Signup and view all the answers

    What mode of cell culture utilizes variables such as culture dynamics and vessel geometries?

    <p>Perfused systems</p> Signup and view all the answers

    Which of the following statements about cell manufacturing timelines is true?

    <p>Current manufacturing processes have been in use for over 40 years.</p> Signup and view all the answers

    In which culture system can multi-layer flasks be used?

    <p>Cell factories</p> Signup and view all the answers

    What is the primary aim of regenerative medicine bioprocessing?

    <p>To create scalable and robust manufacturing processes</p> Signup and view all the answers

    Which factor is a critical quality attribute in regenerative medicine?

    <p>Cell quality and viability</p> Signup and view all the answers

    What is a significant disadvantage of using primary cells in regenerative medicine production?

    <p>There is donor-to-donor variability</p> Signup and view all the answers

    In which cell manufacturing paradigm is the process of clonal cell line creation primarily involved?

    <p>Single cell isolation</p> Signup and view all the answers

    What is one major difference between regenerative medicine bioprocessing and traditional biopharmaceutical production?

    <p>Regenerative medicine focuses on cell quality as the product basis</p> Signup and view all the answers

    What characteristic is essential for maintaining the critical quality attributes of living cell products during bioprocessing?

    <p>Managing nutrient supply effectively</p> Signup and view all the answers

    What is the role of passage/sub-culture in cell expansion?

    <p>It prevents senescence in primary cells</p> Signup and view all the answers

    What aspect of cell expansion presents a challenge in regenerative medicine?

    <p>The scalability of the established bioprocesses</p> Signup and view all the answers

    Which type of cells primarily contains limited expansion potential?

    <p>Primary cells</p> Signup and view all the answers

    What role do microcarriers play in cell culture for regenerative stem cells?

    <p>They provide a solid substrate for cell attachment.</p> Signup and view all the answers

    Which of the following materials is not mentioned as a type of microcarrier available?

    <p>Silicone</p> Signup and view all the answers

    What is a key advantage of using modified surface chemistries on microcarriers?

    <p>They enhance cell attachment and proliferation.</p> Signup and view all the answers

    How can different types of microcarriers influence cell behavior?

    <p>By affecting cell attachment and extracellular matrix production.</p> Signup and view all the answers

    Which property is not typically associated with microcarriers used in bioreactors?

    <p>High throughput of large scale progenitor cells.</p> Signup and view all the answers

    What characteristic of microcarriers is critical for their function in regenerative stem cell culture?

    <p>They should provide a large surface area for cell growth.</p> Signup and view all the answers

    Which of these statements is true regarding the types of microcarriers available?

    <p>Microcarriers can be made from both natural and synthetic materials.</p> Signup and view all the answers

    What effect does surface chemistry modification have on microcarriers?

    <p>It improves cell adherence and proliferation rates.</p> Signup and view all the answers

    Which microcarrier type is specifically named as a dextran-based option?

    <p>Cytodex</p> Signup and view all the answers

    What is a potential consequence of poor surface area-to-volume ratio in cell culture systems?

    <p>Reduced nutrient availability for cells.</p> Signup and view all the answers

    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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    Related Documents

    Ucl Lecture 9: Cell Expansion for Regenerative Medicine PDF
    Ucl Cell Expansion For Regenerative Medicine Lecture 9 PDF

    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.

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