After reading the material for this week, please respond to one of the bullet points below:
Given all the concerns that exist around biotechnology, and in particular genetically modified organisms, what steps can a biomanufacturing company take allay those fears? Who are the stakeholders of a biomanufacturing plant? What safety concerns might each group have? What specific steps would you take to address concerns of employees? How can risks be managed?
Describe what documentation would be required to start manufacturing of penicillin from E. coli in Massachusetts. If the company wanted to manufacture a live attenuated Q fever vaccine, would the process be different?
The local residents of your biomanufacturing facility are concerned about the impact the company is having on the environment and the safety of having so many chemicals and GMOs in their neighborhood. As a manager of the company tasked with addressing the concerns, write a letter to the local residents association outlining what steps the company takes to minimize its environmental impact and how it ensures safety.
Describe the biosafety level classification system in the U.S. and the biohazard risk classification used by the WHO. What additional safety concerns are there for BL3-LS? What documentation and additional safety precautions would a company need to take to manufacture at this level? What building modifications might be required and how might the production process be modified?
During routine sampling from the fermentor, the QA lab reports that they have found bacterial contamination. As the head of the production line what do you do? What happens if after getting the fermentor back on line you get a recurrence?
Describe the similarities and differences between FMEA and RCA. Watch this video: [https://www.youtube.com/watch?v=c9JY3eT4cdM] Apply the principles of RCA to identify the true cause of the problem and the actions necessary to eliminate it.
Read this case study [https://www.health.state.mn.us/facilities/patientsafety/adverseevents/toolkit/docs/6mederror_casestudyrev101513.pdf] Describe the application of RCA techniques to identify why it happened, the cause of this error and what recommendations you would make to prevent it happening again.
Describe how FMEA can be implemented in a bioproduction facility. What steps did Lonza take to prevent problems at its Portsmouth, NH facility?
