Breakout Box: Biomanufacturing Mission

• Practice and understand the roles of upstream and downstream manufacturing processes in making a biologic
• Practice current Good Manufacturing Practices such as aseptic technique, documentation and verifications

Texas Essential Knowledge and Skills

Biology
4.C: research and explore resources such as museums, libraries, professional organizations, private companies, online platforms, and mentors employed in a science, technology, engineering, and mathematics (STEM) field in order to investigate STEM careers.
7.D: discuss the importance of molecular technologies such as polymerase chain reaction (PCR), gel electrophoresis, and genetic engineering that are applicable in current research and engineering practices.

Chemistry
4.C: research and explore resources such as museums, libraries, professional organizations, private companies, online platforms, and mentors employed in a science, technology, engineering, and mathematics (STEM) field in order to investigate STEM careers.
11.F: calculate the dilutions of solutions using molarity

Principles of Bioscience
3.C: identify and define terms related to biotechnology regulations such as Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Globally Harmonized System (GHS);
6.A: identify biotechnology manufacturing processes and their end products, including waste and marketable products;
7.C: identify applications of medical and pharmaceutical biotechnology such as genetically modified cells, antibodies, vaccine and gene therapy, genetic testing for human disease/disorders, three-dimensional bio-printing, and medicines from plants, animals, fungi, and bacteria

Biotechnology I
5.H: identify applications in medical biotechnology such as vaccines production, stem cells therapy, gene therapy, pharmaceutical production, pharmacogenetics, genomics, synthetic biology, and personalized medicine
8.C: explain the role of tissue cultures in genetic modification procedures
9.B: analyze policies and procedures used in the biotechnology industry such as quality assurance, standard operating procedures (SOPs), Good Manufacturing Practices (GMPs), and International Organization for Standardization (ISO) quality systems.
10.A: measure volumes and weights to industry standards with accuracy and precision
11.A: demonstrate aseptic techniques for establishing and maintaining a sterile work area;
11.B: prepare, dispense, and monitor physical properties of stock reagents, buffers, media, and solutions
11.C: calculate and prepare a dilution series

Biotechnology II
8.D: isolate a specific protein from a biological sample using techniques such as chromatography and Western blot analysis
9.A: prepare and maintain tissue cultures commonly used in genetic modification procedures
10.A: demonstrate aseptic techniques for establishing and maintaining a sterile work area;
10.B: prepare, dispense, and monitor physical properties of stock reagents, buffers, media, and solutions
10.C: calculate and prepare a dilution series
10.E: prepare multi-component solutions of given molarity or concentration and volume
11.F: describe Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Documentation Practices (GDP), Good Lab Practices (GLP), and International Organization for Standardization (ISO)
11.I: apply and create industry protocols such as laboratory method protocols, standard operating procedures (SOPs), and validation forms