Question 1: Monoclonal antibodies are produced using hybridoma technology, which involves fusing a specific type of immune cell with a tumour cell. Ethical issues arise regarding the use of animals and the potential for genetic modification. Explain why these ethical concerns are significant in the context of monoclonal antibody production.

Answer: Ethical concerns are significant because they involve animal testing, genetic modification, and potential impacts on animal welfare, which raise questions about the morality and safety of the process.

Question 1: Define monoclonal antibodies.

Answer: Monoclonal antibodies are identical antibodies produced from a single clone of cells, designed to target specific antigens.

Question 2: Describe one ethical issue related to using animals in monoclonal antibody production.

Answer: One issue is the potential suffering and harm caused to animals used in the production process.

Question 1: A laboratory produces 10,000 doses of monoclonal antibodies in a year. If each dose costs £50 to produce, what is the total annual production cost?

Answer: £500,000

Question 2: If the production cost per dose decreases by 10% through improved efficiency, what is the new cost per dose?

Answer: £45

Question 1: Outline two safety precautions that should be observed when working with hybridoma cells in a laboratory setting.

Answer: Using sterile techniques to prevent contamination and wearing appropriate personal protective equipment such as gloves and lab coats.

Question 2: Identify one ethical consideration that scientists should take into account before starting experiments with hybridoma technology.

Answer: Ensuring that animal welfare is protected and that the use of animals is justified and minimised.

Question 1: A pharmaceutical company has developed a new monoclonal antibody treatment. They claim it is highly effective but used genetically modified mice in its production. Discuss the ethical implications of using genetically modified animals in this context.

Answer: Using genetically modified mice raises ethical concerns about animal welfare, potential ecological impacts, and moral questions about genetic manipulation. While the treatment benefits human health, it is necessary to balance these benefits against the ethical costs, ensuring humane treatment and considering alternative methods.

Question 1: Suggest one way in which ethical considerations might influence regulatory decisions on the approval of monoclonal antibody treatments.

Answer: Regulators might require evidence that animal welfare has been protected and that ethical guidelines for genetic modification and animal testing have been followed before approving treatments.

Question 2: Explain how public opinion can impact the development and acceptance of monoclonal antibody therapies.

Answer: Public opinion can influence funding, regulation, and research priorities. Ethical concerns raised by the public about animal testing or genetic modification may lead to stricter regulations or delays in approval, but public support can also accelerate acceptance if ethical standards are met.