| (D) compare and contrast vectors commonly used in biotechnology
applications, including plasmids, adenoviruses, retroviruses, and
bacteriophages;
(E) explain the steps and components of the polymerase
chain reaction (PCR); and
(F) explain applications of CRISPR/Cas9 technology
in gene editing and diagnostics.
(11) The student prepares solutions and reagents for
the biotechnology laboratory. The student is expected to:
(A) demonstrate aseptic techniques for establishing
and maintaining a sterile work area;
(B) prepare, dispense, and monitor physical properties
of stock reagents, buffers, media, and solutions;
(C) calculate and prepare a dilution series;
(D) determine acceptability and optimum conditions
of reagents for experimentation; and
(E) prepare multi-component solutions of given molarity
or concentration and volume.
(12) The student investigates the role of quality in
the biotechnology industry, The student is expected to:
(A) describe the product pipeline in the biotechnology
industry;
(B) describe the importance of quality assurance and
quality control;
(C) explain the importance of documentation to quality
assurance and quality control;
(D) describe the importance of corrective and preventive
action (CAPA);
(E) describe Quality Management Systems (QMS) components,
including inspection, audit, surveillance, and prevention;
(F) describe Good Manufacturing Practices (GMP), Good
Clinical Practices (GCP), Good Documentation Practices (GDP), Good
Lab Practices (GLP), and International Organization for Standardization
(ISO);
(G) perform validation testing on laboratory reagents
and equipment;
(H) analyze data and perform calculations and statistical
analysis on results of quality-control samples such as standard deviation
and percent error; and
(I) apply and create industry protocols such as laboratory
method protocols, standard operating procedures (SOPs), and validation
forms.
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