Biotechnology Timeline
Clinical Trials
Manufacturing Process
Quality Control and Assurance
Biomanufacturing Careers
100
In 1797 Edward Jenner created the first vaccination, what was the vaccination for?
What is smallpox?
100
The evaluation of pharmaceuticals is highly regulated and requires many steps in order to ensure drug safety and effectiveness, what is this process known as?
What is the drug development process?
100
In what step of the manufacturing process do scientists order the raw materials and test the materials needed to make a product in order to make sure that they meet quality standards?
What is synthesis?
100
What are the three departments that manufacturers have to ensure quality?
What is Quality Control (QC), Quality Assurance (QA) and Validation?
100
What is the name of the position that is responsible for a variety of tasks in monitoring the control of manufacturing the product?
What is Process Technician?
200
In 1857 a scientist conducted an experiment to support the germ theory of disease, who was this scientist?
Who is Louis Pasteur?
200
What stage of clinical testing involves the use of animals and NOT humans in order to test the safety of a drug? (HINT: This is the first stage that takes place before human testing)
What is pre-clinical testing?
200
In the second step of the manufacturing process, known as purification, what takes place?
What is the removal of the chemicals used in the process?
200
What department ensures product quality by setting up and checking SOPs (standard operating procedures)?
What is Quality Assurance?
200
What position works with technicians to ensure that the product is manufactured properly?
What is Process Engineers?
300
In 1859 Charles Darwin published this famous theory?
What is theory of evolution by natural selection?
300
An IND or Investigational New Drug Application, is submitted to what governmental agency to request permission for human testing?
What is the FDA?
300
What is the name of the step in the manufacturing process that involves mixing operations to blend active ingredient with other substances that are needed in the final form?
What is formulation?
300
What is the main goal of the Validation department?
What is to prove that a manufacturing process will consistently produce the product to the predefined specifications?
300
What is at least one task that a quality control associate would complete?
What is coordinate activities needed to document good manufacturing practice (GMP), review data obtained by the QC assistant and report abnormalities or update SOPs?
400
Gregor Mendel started what type of scientific study by studying the flowers in his garden?
What is the science of genetics?
400
What phase involves the most extensive and expensive testing of a drug and involves the most participants?
What is phase 3?
400
In step four, final dosage form preparation, what are the three main actions that take place?
What is the formula preparation is made into its final form; the final form is dispensed into containers; and the containers are labeled and packaged?
400
What defines a particular process in exact detail so that the process can be replicated the exact same way every time?
What is the Standard Operating Procedure (SOP)?
400
What might someone's job in research and development include?
What is working in labs separate from the manufacturing facility, perform lab experiments and tests according to good laboratory practices, or seek out new and more efficient ways to use and produce products that already exist?
500
In 2002 a draft of what famous and important scientific project was published?
What is the human genome?
500
What is a company's main goal in post-marketing surveillance?
What is continuing to report information about new finding and problems after drug approval to the FDA?
500
As cells grow and multiply, they are introduced into what?
What is a small bioreactor?
500
What are the five rules for quality?
What is understand customer needs, say what you do, do what you say, prove it, and improve it?
500
What position involves identifying new drug targets, creating animal models to test new drugs, and investigating the causes of and treatments for diseases?
What is a research scientist in drug discovery?
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