What is Biotechnology?

1. Biotechnology Program: Training in BioprocessingKari ClaseAssistant Professor, Industrial TechnologyCoordinator Biotechnology ProgramLead Scientist for Learning Bindley Bioscience CenterPurdue University

2. What is Biotechnology? • bio—the use of biological processes • technology—to solve problems or make useful products • Harnessing the properties of a living organism to develop and manufacture products that benefit human life • Not a new field • 10,000 years ago: began growing crops and raising animals to provide stable supply of food and clothing • 6,000 years ago: biological processes of microorganisms to make useful food products, such as bread and cheese, and to preserve dairy products

3. The Big PictureBiotechnology Applications • Medical • Human: Therapeutics, Diagnostics • Animal: Therapeutics, Diagnostics • Agriculture • Plant: Crops, Horticulture, Forestry (Food, Feed and Fiber) • Animal: Mammal, Poultry, Fish (Food, Pharming, Model systems) • Environment:Low impact alternatives, Pollution amelioration, Biomass conversion, Detection and analysis systems • Industrial applications: Enzymes, Food, Feedstocks, Fuels, Microbiological mining

4. Human Genome Project

5. Human Genome Program, U.S. Department of Energy, Genomics and Its Impact on Medicine and Society: A 2001 Primer, 2001

6. g g c c g g g g g c g c g g g c g g g c t c g g c Advanced Genomics Will Accelerate Discovery of Next Generation Products Genome Gene map Gene sequence Gene expression Ag traits Pharma traits c Yield t Alzheimers Drought Breast Cancer a t t Disease Arthritis Stress t t t Stress a a t t Stress CV Disease a a t Aging Oil quality a a t t t Disease Obesity Vision Yield Aging Maturity a t t Arthritis Herbicide tolerance

7. Medicine and the New Genetics Gene Testing  Pharmacogenomics  Gene Therapy • Anticipated Benefits: • • improved diagnosis of disease • earlier detection of genetic predispositions to disease • rational drug design • gene therapy and control systems for drugs • personalized, custom drugs U.S. Department of Energy Genome Programs, Genomics and Its Impact on Science and Society, 2003

8. New Procedures Lead to New Technology • Affymetrix “DNA Chip” • Computers to Help in Analyzing Large Sets of Data. • New technology has driven the need for a skilled workforce that can understand what is being tested

9. Biotechnology Industry is an Economic Engine • Tremendous advances are being made in pharmaceutical and biotechnology discoveries and their applications (including manufacturing), as well as in health care services • As a result, there is an increasing sophistication of the products and services available and being developed, with an ever-widening scale of applications and marketing • The growth of biotechnology results in ever-expanding needs for college graduates who have knowledge of life-science based products and processes 1Miller, Thomas P., and Associates for Indiana Health and Industries Forum. (2002). The Indiana Health Industries Workforce Study. Retrieved October 6, 2004, from http://www.ihif.org/industryinfo.aspx

10. Workforce Gap Projected Within Biotechnology Industry • There have been numerous reports of current and projected shortages of human resources possessing the required knowledge in the growing industry1 • The need for an educated workforce in biotechnology manufacturing also exists beyond Indiana • “The biotechnology industry is still in its adolescence, but it is about to have a major impact on health care. A third of drugs in phase III clinical trials are proteins…biotech companies are gearing up to manufacture product but they face a shortage of talent, as most young scientists interested in biotechnology have congregated to research.” 2,3,4 1Miller, Thomas P., and Associates for Indiana Health and Industries Forum. (2002). The Indiana Health Industries Workforce Study. Retrieved October 6, 2004, from http://www.ihif.org/industryinfo.aspx 2Kling, Jim. Careers in Biotech Manufacturing. Science’s Next Wave, April 23, 2004. Retrieved January 5, 2005 from http://nextwave.sciencemag.org/ 3Cliff Mintz, CEO of the training and staff search firm BioInsights Inc. quoted by Jim Kling. Careers in Biotech Manufacturing. Science’s Next Wave, April 23, 2004. Retrieved January 5, 2005 from http://nextwave.sciencemag.org/ 4 Louet, Sabine. Get Ready to Scale Up. Science’s Next Wave, March 21, 2003. Retrieved January 5, 2005 from http://nextwave.sciencemag.org/

11. An Academic Minor in Biotechnology was Developed to Address the Gap Between Education and the Workforce • Interdisciplinary effort among the College of Technology, the College of Science, and the College of Pharmacy • Program is administered within the Department of Industrial Technology • Available to any Purdue University student majoring in any four-year degree baccalaureate degree program • Biotechnology laboratory activities were implemented fall 2004 to provide education on skills unique for life sciences manufacturing

12. Students will Possess both a Manufacturing Knowledge Base and an Expertise in Scientific Research • Meet the rising demand by industries for competent individuals to develop and manufacture biological (life science-based) products on an industrial scale • Higher order learning with action-based research and curriculum • will increase analytical skills • better prepare students for real world jobs by enabling them to transfer curriculum-based research experiences into the biotechnology industry

13. Active, Inquiry-Based, and Collaborative Learning • A large body of recent research published by the National Research Council in “How People Learn: Brain, Mind, Experience and School,” supports engaging students with undergraduate research • Studies have shown that by actively engaging undergraduate students in research, their retention of scientific principles and learning retention increases • “The results show that many standard instructional practices in undergraduate teaching are relatively ineffective at helping students master and retain the important concepts of their disciplines over the long term. Moreover, these practices do not adequately develop creative thinking, investigative, and collaborative problem-solving skills that employers often seek….students assimilate new knowledge more effectively in courses including active, inquiry-based, and collaborative learning.” Wood, William B. and Gentile, James M. (2003) Teaching in a Research Context. Science, 302 (5650), 1510.

14. Biotechnology Program Matches Strategic Plan • Improve student learning and discovery by integrating and applying life science to technology through laboratory-based instruction • encouraging interdisciplinary research connections among students and faculty • Collaborate with area high schools, community colleges and industries to help Indiana’s future growth and development in biotechnology BIOTECHNOLOGY PROGRAM

15. Academic Minor in Biotechnology • BIOL 112 Fundamentals of Biology I • BIOL 113 Fundamentals of Biology II • BIOL 241 Biology IV: Genetics & Molecular Biology • BIOL 295E The Biology of the Living Cell • IT 226 Biotechnology Lab I • IT 227 Biotechnology Lab II • CPT 227 Introduction to Bioinformatics • IPPH 522 Good Regulatory Practice • IT 342 Introduction to Statistical Quality

16. Students participating in the minor and their college

17. Several Career Paths in Biotechnology Industry • Research and Development • Generates and tests the ideas that become new biotechnologies • Clinical Research • Get ideas generated by R&D and take them into the field for “real world” tests and observations • Quality Control • Ensures products are developed and tested safely in accordance with law • Sales and Marketing • Communicate effectively with researchers and customers • Regulatory • Ensure the company is in compliance with government regulations for new products

18. Cellular and Molecular Biology Biotechnology Laboratory I Introduce students to biotechnology and prepare students for immersion into biotechnology research project Good Regulatory Practice Biotechnology Laboratory II Genomics and proteomics research project Statistical Quality Introduction to Bioinformatics Analysis of experimental biological data derived from research project Courses within the Biotechnology Program

19. Biotechnology Lab Activities • Bioinformatics Modules • Hands-on Laboratory Activities at Bindley Bioscience Center • Critique of Scientific Journal Articles and Writing Activities

20. Hands-on Laboratory Experiences Provided at Bindley Bioscience Center • Deoxyribonucleic acid (DNA) and protein fingerprint analysis • DNA sequencing • Polymerase chain reaction (PCR) informatics analysis • DNA and protein separation by electrophoresis • Enzyme-linked immunoabsorbant assay (ELISA) immunoassay • Bacterial transformation and recombinant gene expression • Protein chromatography • Nucleic acid isolation

21. Biotechnology Lab I Biotechnology Lab II Bioinformatics Research and Discovery Develop technology Bindley Bioscience Center Validate protocols

22. Students develop technology for new discoveries Bindley Bioscience Center Express alternatively spliced protein isoforms with novel peptide tag Isolate interactome using mass spec Stratagene Tandem Affinity Purification New Technology For Biological Systems Research Identify interacting proteins and map signaling pathways with bioinformatics

23. Future Directions • Expand the integration of biotechnology research projects into the classroom • Integrate lab activities with regulatory course • Develop collaborations with teacher education programs

24. Future: Good Regulatory Practice • Current course topics adapted from masters level to the undergraduate classroom • Drug discovery and development • Clinical research, marketing and ethics • Clinical studies • Food and drug law • Good manufacturing, good laboratory and good clinical practices • Develop case studies to integrate biologics into the regulatory course and facilitate connection with laboratory modules from the biotechnology core curriculum

25. Future: Technology Education • Standards for technological literacy and pre-engineering curriculum (PLTW) • Biotechnical engineering course for high school students • Teacher education program • Teachers to help increase students pursuing careers in STEM disciplines • Biomanufacturing DURI project (chemical engineer and technology education student) • Biomanufacturing curriculum • Ivy tech

26. Future: Entrepreneurial Certificate Program • Technology development • Guest lectures from biotechnology industry • Electronic portfolio • Understand the current trends and emerging technology within the biotechnology industry • Identify where gaps exist between current technology needs and existing solutions • Recognize existing gaps between biotechnology needs and current solutions as opportunities • Explore potential solutions for new technology development to address identified needs within the biotechnology industry

27. Creativity and communication are key attributes for the engineer of 2020 • “Creativity (invention, innovation, thinking outside the box, art) is an indispensable quality for engineering, and given the growing scope of the challenges ahead and the complexity and diversity of the technologies of the 21st century, creativity will grow in importance” • “…good engineering will require good communication….we envision a world where communication is enabled by an ability to listen effectively as well as to communicate through oral, visual and written communication” National Academies of Engineering of the National Academies. 2004. The Engineer of 2020: Visions of Engineering in the New Century. Washington D.C.: National Academy Press

28. Engagement: NSF Advanced Technological Education

29. Discovery through Engagement: A Biotechnology Learning Continuum • Biotechnology Theme focused on education and immersion within a corporate environment • Thematically clustered courses including seminars • Mentoring experiences with participants from industry • Field trips to industry, both plant sites and corporate headquarters • Internships and co-op opportunities with industry • Service learning opportunities with 8th to 12th graders in Purdue’s Science Bound program • Research at Discovery Park Courses Mentoring Internships Service Learning

30. Biotechnology Learning Community Continuum

31. Biotechnology Core Curriculum From Learning Community Continuum Applied Research in Biotechnology (biomanufacturing, genomics, proteomics) Capstone Regulatory Compliance; Applied Statistics, Six Sigma, and Lean Manufacturing Integration of Reseach Projects and the Students in Action Learning Continuum Develop technology and Validate protocols Projects from Industry or Bindley Bioscience Center Completed Project for Discovery Park Centers and Industry Partners Graduation and Employment within Biotechnology Industry