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Questions and Answers
Why is it crucial for genetically modified cells to continually produce products without any change in cell expression systems and productivity?
What is a characteristic of mammalian cells that affects their use in biologics production?
Why is it important to ensure that host cells produce recombinant proteins in the correct form?
What is a challenge associated with producing glycoproteins in host cells?
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What is an advantage of cell systems for producing biologics?
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What can affect the rheological properties of yeast in submerged fermentation?
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What is a potential issue with fungal cells in submerged fermentation?
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Why is it important for cells to be resilient to physical and chemical stresses?
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What can affect the productivity of mammalian cells in biologics production?
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What is a characteristic of cell systems that can affect their use in biologics production?
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Study Notes
Biopharmaceutical Production
- 80% of recombinant protein-based biopharmaceuticals are monoclonal antibodies, which require mammalian and human cell lines for production due to their size and complex formation.
Cell Systems for Biopharmaceutical Production
- Mammalian and human cell lines are used for biopharmaceutical production despite their inherent disadvantages compared to bacteria and yeast for manufacturing in bioreactors.
- Examples of biopharmaceuticals produced by mammalian and human cell lines include Avastin, Herceptin, Humira, Factor VIIA, and Velglucerase alfa.
Stem Cells
- Stem cells are unspecialized cells in multicellular organisms that allow tissue maintenance and repair, and have the ability to differentiate into other cell types and replicate.
- Stem cells are becoming more widely used in biopharmaceutical production.
History of Biopharmaceuticals
- Before recombinant proteins, biological drugs were sourced from animals and humans.
- 1986: First therapeutic monoclonal antibody approved for use in humans (muromonab-CD3), and first recombinant vaccines from yeast approved (Recombivax HB - Hepatitis B vaccine).
- 2002: Fully-human mAB, adalimumab (Humira) approved for use.
- 2006: First single-use stirred-tank bioreactor for cell culture, and approval of the first plant-made vaccine (Newcastle disease vaccine for poultry).
- 2007: Approval of first production of human recombinant from transgenic animals (antithrombin alpha, rEVO Biologics).
- 2010: Creation of the first synthetic cell.
Cell Factories
- Today's cell factories include wild-type, mutated, and recombinant bacteria, yeast, fungi, algae, plant, animal, insect, avian, mammalian, and stem cells.
Requirements for Biopharmaceutical Production
- Genetically modified cells must continually produce product without changing cell expression systems and productivity.
- Mammalian cells are inherently more unstable and can only divide a certain number of times before needing to be replaced.
- Cells are prone to contamination by viruses and must be resilient to withstand physical and chemical stresses.
- Recombinant proteins must be produced in the correct form or can be manipulated into the active form during downstream processing.
- Cells can have different forms in submerged (liquid) fermentation, which can affect mixing or mass transfer.
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Description
This quiz covers the production of biopharmaceuticals, focusing on the use of mammalian and human cell lines due to the complexity of monoclonal antibodies. It also discusses the advantages and disadvantages of different cell systems for biopharmaceutical manufacturing. Test your knowledge of bioprocessing and upstream production.
