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the U.S.responsible for regulatory oversight of biotechnology. Concepts of current good laboratory practices (cGLP),current good manufacturing practices (cGMP),standard operating procedures (SOP) and validation will be addressed as they apply to industry.

BIOT 104 cGMP and Quality Compliance

3 Credits

Prerequisites:BIOL 121 or Program Chair Approval.Overview of cur- rent good manufacturing practices in the global pharmaceutical industry.Emphasis will be placed on the understanding of the simi- larities and differences between the good manufacturing practice requirements in the United States,Europe,Canada and Japan. Students will also explore the different quality systems and process-

es needed in the pharmaceutical industry. BIOT 105 Survey of Regulatory Affairs

3 Credits

Prerequisite:Program Chair Approval.This course provides an entry level introduction to the laws and regulations that govern the development,marketing and commercial distribution of drugs,bio- logical and medical device products and how they relate to the pharmaceutical,biotechnology and medical device industry.This course in intended to provide individuals with a greater understand- ing of regulatory affairs,specifically providing an understanding of how their actions are controlled by regulations and how to interact

with FDA or global regulatory agencies. BIOT 117 Quality Control Techniques

3 Credits

Prerequisite:BIOT 101.Students will be introduced to those princi- ples associated with quality control from a life sciences perspective. Students will learn about common microbial contaminants and how to prevent them.Students will also gain experience with common monitoring techniques used in the biotech industry.

BIOT 201 Cell Culture and Cellular Processes

4 Credits

Prerequisites:BIOT 101 and CHEM 105 or CHEM 111.An introduction to major biochemical pathways,cellular structure and function at a molecular level.Topics to be considered include the structure and function of the cell membrane,cytoskeleton and various organelles. Cellular respiration will be discussed.Protein synthesis,processing and export will be examined.Those processes involved in cell divi- sion will also be investigated and related to cancer.The laboratory will center upon techniques involving animal,plant,fungi and bac- terial cell cultures.Students will be taught how to isolate,culture and preserve prokaryotic organisms.Students will be taught how to maintain and preserve eukaryotic cell cultures.Students will learn to

procure cell cultures from ATCC and other repositories.Includes lab.

BIOT 211 Analytic Methods in Biotechnology I 3 Credits Prerequisites:BIOT 101 and CHEM 105 or CHEM 111.Theory and appli- cation of many analytical methods currently utilized in the field of biotechnology.These methods will include:ELISA and immunoaffinity techniques;methods for determining enzymatic activity;spectropho- tometric methods;chromatographic methods;electrophoresis;light

and electron microscopy.When feasible,techniques will be practiced in the laboratory setting.Methods utilizing radioactive isotopes will be discussed.Considerable emphasis will be placed on proper methods for data recording,analysis and presentation.Includes lab.

BIOT 212 Analytic Methods in Biotechnology II

3 Credits

Prerequisites:BIOT 211.Theory and application of many analytical methods utilized in the field of biotechnology.These methods will include:centrifugation,light and electron microscopy,restriction endonuclease digestion,agar and acrylamide electrophoresis of nucleic acids,Southern and Northern blotting,polymerase chain reaction and bioassays.When feasible,techniques will be practiced in the laboratory setting.Methods utilizing radioactive isotopes will be discussed.Considerable emphasis will be placed on proper meth- ods for data recording,analysis and presentation.Includes lab.

BIOT 214 Food and Drug Law

3 Credits

Prerequisite:BIOT 101.This course provides a basic introduction to the laws and regulations that govern the development,marketing and commercial distribution of drugs,biological and medical device products and how they relate to the pharmaceutical,biotechnology and medical devices industry. This course is designed to provide stu- dents with an overall landscape of U.S.and International laws regu- lating the drug,biotechnology and medical device industry.

BIOT 215 Clinical Trials

3 Credits

Prerequisite:BIOT 101.This course provides a basic introduction to clinical trials,including their design,how they are conducted,and concepts of current good clinical practices (cGCPs). This course is designed to provide students with an overall landscape of the clini- cal trial process,FDA regulations and ICH guidelines pertaining to

that process.

BIOT 216 Risk Management for Drugs and Medical Devices

3 Credits

Prerequisite:BIOT 101.This course provides a basic introduction to risk management strategy application of best practices and risk management for both the drug and medical device industry.This course is designed to provide students with an overall understand- ing of this growing discipline to improve patient safety and the reg-

ulatory mandates and laws.

BIOT 217 Biotechnology Manufacturing Processes

3 Credits

Prerequisites:Program Advisor Approval.Introduction to processes and procedures involved in manufacture of biological molecules on both large- and small-scales.Students will learn function of com- monly used manufacturing equipment associated with biotechnolo- gy and understand the cGMP’s associated with use of such equip- ment.The regulatory environment associated with most biotechnol- ogy endeavors will be reviewed including those mandated by FDA, USDA and OSHA.

BIOT 218 Product Life Cycle

3 Credits

Prerequisite:BIOT 101.This course provides a basic introduction to the basic life cycle of both drug and medical device life cycles,from dis- covery through preclinical,clinical trials,and post production concerns.

BIOT 220 Molecular Biology Lectures

3 Credits

Prerequisites:BIOL 121 and CHEM 106.Introduces DNA,RNA and pro- teins and review their structures and functions,including their phys- ical and chemical properties and their roles in cellular metabolism. The course will include an in-depth look at the synthesis of these molecules,as well as DNA replication,transcription and translation.

BIOT 221 Microbiology

3 Credits

Prerequisites:BIOL 121 and CHEM 106.Corequisites:BIOT 222. Presents an overview of microbiology including fundamental struc- tures of microorganisms,their growth,metabolism,interaction with other living things,and classification.Emphasis placed on industrial

applications of microbiology. BIOT 222 Microbiology Laboratory

2 Credits

Prerequisites:BIOL 121 and CHEM 106.Corequisites:BIOT 221.A con- ventional laboratory of exercises,demonstrations and discussions. Laboratory exercises are designed to enable students to achieve pro- ficiency in the principles and techniques necessary for cultivation of microorganisms using aseptic techniques and for performing and interpreting biochemical tests.The laboratory exercises will be filled

out weekly and turned in to be graded.

BIOT 227 Genetic Engineering and DNA Analysis

4 Credits

Prerequisites:BIOT 201 or BIOT 211.The essential concepts and tech- niques in genetic engineering.Students will practice essential gene cloning procedures:isolation of DNA,restriction endonuclease diges- tion, agarose gel electrophoresis analysis,DNA ligation,and trans- formation into a host strain.Other essential techniques such as PCR, construction and screening of genomic or cDNA libraries,Southern and Northern blot analyses will be practiced.Students will under- stand the principles and ethical issues of animal or human cloning practices.Current methods for transfer and propagation of genes into plants and animals will be discussed.Various gene knockout techniques such as homologous gene recombination,site-directed mutagenesis,and RNAi will be introduced.The topics in genomics, proteomics,and bioinformatics will be discussed.Includes lab.

BIOT 231 Industrial Processes and Fermentation

4 Credits

Prerequisites:BIOT 201.An introduction to fermentation processes used for commercial purposes and the operation of small- and large-scale fermentors.Methods used to harvest product from fer- mentors and the regulatory requirements associated with commer- cial fermentation will also be explored.Includes lab.

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