Biotechnology and Good Manufacturing Practice

Biotechnology and Good Manufacturing Practice Courses

• •  

  • Code

  • Course

  • Credits

• • BIO 251

  • Microbiology w/Lab

  • 4
  (formerly BIO 151) A study of non-pathogenic and pathogenic microorganisms designed primarily for students in the health sciences area. Topics covered include: microbial characteristics, control of micro-organisms, defenses of the host, and cause, prevention, and control of infectious diseases. Safety protocols must be observed in all lab classes. These include: no food, no drink, and no open-toe shoes, appropriate clothing. Only registered students may enter labs. Prerequisite: BIO 111 with “C” or better. Placement at ENG 101 level strongly advised.
• • BTC 101

  • Introduction to Biotechnology

  • 4
  This course is designed to introduce the student to the role of biotechnology in the fields of medicine, environmental science, forensics, microbes and agriculture. The student will explore the theory, tools and application behind the genetics involved in these fields. This lab-based, hands-on course will expose the student to the techniques and equipment utilized in scientific laboratories around the world. Prerequisites: CHE 121/131 and/or BIO 111/121. One course allowed concurrently.
• • BTC 210

  • Biochemistry

  • 4
  This course is designed to introduce the student to the biochemical principals involved in the synthesis, structure and function of biologically important molecules (Proteins, Lipids, Carbohydrates and Nucleic Acids). Examination of the intricate relationship between the structure and function of these molecules will give insight into the biological processes of the living cell. Topics will include: catalytic activity and kinetics of enzymes; how molecules outside the cell regulate what happens inside the cell; how understanding the biochemistry of these molecules has spurred the growth of a relatively new industry - Biotechnology. Prerequisites: CHE121/131 and MAT103 with “C” or better. Safety protocols must be observed in all lab classes. These include: no food, no drink, and no-open-toe shoes, appropriate clothing. Only registered students may enter labs.
  
  This course includes an additional 3 hour lab.
  
• • BTC 220

  • Bio manufacturing I

  • 4
  This course is the second in the series of cornerstone courses in Biotechnology and Compliance and the first of three courses in Bio manufacturing. This lab-based course is designed to introduce the student to the high-tech world of manufacturing prescription drugs. The course begins with an overview of bio manufacturing, its rapid growth and the industries need for well trained employees. We examine the need for the Food and Drug Administration (FDA) and their requirements for current good manufacturing practices (cGMP). The student will become skilled in the techniques and equipment necessary to manufacture a recombinant protein. The goal of the course is to manufacture a mammalian protein in bacteria following cGMP’s and standard operating procedures through upstream and downstream processes. Quality control methods will stringently test the protein product and validate its purity. Prerequisites: CHE121/131, BIO111/121, and BTC101.
• • BTC 230

  • Bio manufacturing II

  • 4
  This course is the third in the series of cornerstone courses in Biotechnology and Compliance and the second of three courses in Bio manufacturing. This lab-based course is designed to give students experience in various aspects of bio manufacturing including but not limited to: Process development, Quality Control, Environmental Health and Safety, and Upstream and Downstream Processing. The course begins with the aseptic techniques involved in the culturing and preservation of mammalian and yeast cells. Scale-up techniques (upstream processing) will then be used to culture a 1 milliliter volume of cells (106) into 3-10 liter columns containing many trillions of cells (1012). An in-depth discussion of downstream processing techniques such as tangential flow filtration and protein purification systems will be utilized to purify a protein product (drug) from the cell media. Strict adherence to current good manufacturing practices (cGMP) will be followed and the protein products will be tested and validated for purity. Prerequisites: CHE 121, BIO 111, BIO 251, BTC 101, BTC 201, BTC 220.
• • BTC 240

  • Seminar in Biotechnology

  • 1
  Seminar-style capstone course covering professional topics in biotechnology and compliance, including but not limited to: discussion of emerging technologies, innovations, and new products that are noteworthy to the biotechnology industry; the steps involved with the regulatory approval process for a new biotechnology-derived product, and; key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products. Students, working in teams, will give written and oral presentations on case studies that attempt to predict products derived from the new innovations and discoveries. The objective of the course is to give the student insight into the process of translating scientific discovery into innovative products. Prerequisite: BTC 220 Core-requisites: BTC 230 & BTC 250.
• • BTC 250

  • Bio manufacturing III

  • 4
  This course is the fourth in the series of cornerstone courses in Biotechnology and Compliance and the final courses in bio manufacturing. This lab-based course is designed to give students experience in manufacturing a retail product – Science Laboratory Kits. Applying technical skills acquired from previous manufacturing course work, students will design science kits to be used in Quincy College’s science labs as well as high school science class. Students will write standard operating procedures (SOP’s) for the production of kit components, write experimental protocols for use by science teachers in the lab, manufacturing kit components following SOP’s as well as assemble and validate the kits. Strict adherence to current good manufacturing practices will be applied. Prerequisites: CHE121/131, BIO111/121, BIO151/152, BTC101, BTC220. Core-requisites: BTC 230.
• • CHE 121

  • General Chemistry I

  • 4
  A study of the fundamental chemical laws and theories. Topics include atomic and molecular structure, chemical bonding, stoichiometry, chemical and physical properties, change of state, solution chemistry and gas laws. Safety protocols must be observed in all lab classes. These include: no food, no drink, no open-toe shoes, appropriate clothing. Only registered students may enter labs. Safety protocols must be observed in all lab classes. These include: no food, no drink, no-open-toe shoes, appropriate clothing. Only registered students may enter labs. Prerequisite: MAT 103 with “C” or better.
• • CHE 122

  • General Chemistry II

  • 4
  A continuation of General Chemistry I. Additional topics include solution properties and equilibria, chemical kinetics, thermodynamics, and nuclear chemistry. Also, an introduction to organic chemistry along with a survey of biochemical applications. Safety protocols must be observed in all lab classes. These include: no food, no drink, no open-toe shoes, appropriate clothing. Only registered students may enter labs. Safety protocols must be observed in all lab classes. These include: no food, no drink, no-open-toe shoes, appropriate clothing. Only registered students may enter labs. Prerequisites: CHE 121 with “C” or better.