Production of pharmaceuticals

• What techniques are used in the purification process of pharmaceuticals?

  Chromatography and filtration
• What is the purpose of cell culture and fermentation in biotechnology?

  To mass-produce therapeutic proteins or drugs.
• What is the purpose of genetic engineering in pharmaceuticals?

  To produce specific proteins cheaply and efficiently.
• What are the main processes involved in biotechnology applications for pharmaceutical production?

  • Genetic Engineering
  • Cell Culture & Fermentation
  • Purification
  • Quality Control
• How is insulin for diabetes commonly produced in the UK?

  Using genetically modified bacteria in fermentation.
• Which organisms are commonly genetically modified for pharmaceutical production?

  Bacteria or yeast
• What role does biotechnology play in pharmaceuticals?

  It helps produce medicines efficiently.
• Why is quality control important in pharmaceutical production?

  To ensure the drug is safe and effective.
• What is the role of the isolated chromosome in this diagram?

  To extract the insulin gene
• What is the purpose of biosafety in cell culture work?

  • To prevent cell alteration and over-passaging
  • To ensure proper cell characterization and identification
  • To avoid intra- and interspecies cross contamination
  • To mitigate chemical, biological, and viral contamination
• What is the process of cell culture for pharmaceutical production?

  1. Grow cells in nutrient-rich culture media

  • Contains sugars, amino acids, and growth factors

  1. Use fermenters for large-scale production

  • Controlled temperature, pH, and oxygen levels

  1. Regular testing for cell health and product concentration
• What are the main components of a cell culture?

  • Mycoplasmas
  • Bacteria
  • Viruses
  • Chemical contamination
• What type of cell is used as the starting point for isolating the insulin gene?

  Human cell
• What are the key steps in the biotechnology process for pharmaceutical production?

  1. Genetic Engineering: Modify organisms to produce proteins.
  2. Cell Culture & Fermentation: Grow cells in bioreactors.
  3. Purification: Separate drugs from contaminants.
  4. Quality Control: Test for safety and effectiveness.
• What is used to cut the plasmid open?

  Enzyme
• What structure is isolated from a bacterium?

  Plasmid
• If you wanted to analyze the genetic profile of cells in a culture, which technique would you use?

  STR profiling
• What are the potential issues that can arise in a cell culture?

  • Cell alteration and over-passaging
  • Cell characterization (STR profiling)
  • Cell misidentification
  • Intra- and interspecies cross contamination
• What is the name of the culture medium shown in the image?

  DMEM
• What is the specific gene isolated from the human chromosome responsible for?

  Insulin production
• What is the name of the bacterium that uptakes the recombinant plasmid?

  Suitable bacterium
• What standards do regulatory agencies set for pharmaceutical companies?

  Manufacturing, clinical trials, and marketing standards
• What are the main steps in the cell line development process?

  • Cell line development
  • Cell culture supplements and media prep
  • Cell prefiltration
  • Sterile filtration
  • Bioreactor
  • Primary clarification
  • Secondary clarification
• What is genetic engineering?

  Transferring genes between organisms
• How does the presence of mycoplasmas, bacteria, and viruses impact a cell culture?

  They can lead to cell alteration, over-passaging, and cross-contamination
• What is the role of the plasmid in the bacterium for this process?

  To carry the insulin gene
• What is the purpose of this genetic engineering method?

  To mass-produce essential medications efficiently
• What does purity determine in pharmaceuticals?

  Freedom from contaminants
• What does stability assess in pharmaceuticals?

  How the drug holds up over time
• What control measures are used to assess stability?

  Storage testing, expiry dating
• Which agency is mentioned as a regulatory body in GB?

  MHRA
• How do regulatory procedures contribute to public safety?

  By ensuring drug efficacy and safety standards
• What is required for growing cells for pharmaceutical production?

  A sterile environment and specific conditions
• What is the formula to calculate the area of a circle with radius $r$?


  $A =$$\pi r^2$
• What do regulatory procedures in pharmaceuticals ensure?

  Compliance with safety and efficacy standards
• What is monitored regularly during cell culture processes?

  Cell health and product concentration
• What is the purpose of fermenters in cell culture?

  To maintain controlled conditions for production
• How does the virus inactivation step work in the downstream process?

  • Virus inactivation uses chemical or physical methods to destroy any viruses present in the product
  • This ensures the final product is safe and free of viral contaminants
• What is the purpose of the culture medium in the image?

  To grow and maintain cell cultures
• What are common threats in cell culture processes?

  • Bacterial/viral contamination
  • Chemical interference
  • Cross-species contamination
  • Require strict controls to mitigate