1. Sonia Wallman, PhD NBC 2 swallman@biomanufacturing.org Yakov Cherner, PhD ATeL, LLC ycherner@atelearning.com Web-Based Virtual and Hybrid Laboratories for Biomanufacturing Curriculum

2. BIOMAN Laboratory Textbook Online Support Online Manuals Complete Suite of Products Fall 2010 Global BioManufacturing Curriculum Virtual Labs

3. Introduction to Biomanufacturing Textbook Authored by Industry Experts 11 chapters plus introduction Currently being piloted by two Biomanufacturing classes, 37 Students total, and by 3 instructors teaching Biomanufacturing Industry interest Scheduled for release, fall 2011

4. Introduction to Biomanufacturing Engineering Operational Excellence Marti Mathews, Biogen Idec Facilities Brian Shingle, Centocor Metrology Gene Kernan, HGSI Validation Patrick Sheehy, HGSI EH&S John Piampiano, Kodak Production Upstream Processing Olga Mollin, Jane Flanagan, Lonza Downstream Processing Paul O’Neil, Pall Euroflow Process Development Ezster Birck Wilson Quality Quality Assurance Cynthia Sarnoski, Frank Hallinan, Pfizer Ron Hudcosky, Merck Microbial Control John Hasyn, MCCC QC Biochemistry Mary Harne, Zhenhong Lee., HGSI

5. Biofuels Curriculum

6. Biofuels Textbook

7. Biofuels Lab Manual

8. Laboratory Manuals  Generic  Custom  CHO – tPA  Pichia pastoris - HSA  Protein is Cash

9. Generic Laboratory Manual Metrology: SOPs for equipment Validation Protocols EH&S Program Quality Assurance: cGMP, SOPs, Batch Records, Equipment Logs Quality Control Microbiology SOPs Upstream Processing: E. coli recombinant for GFP, CHO recombinant for tPA Cell Culture, Pichia pastoris recombinant for HSA Cell Culture Downstream Processing: Purification of human tPA from CHO Cell Culture Purification of human serum albumin from Pichia pastoris Cell Culture Quality Control Biochemistry (Process Development)

10. NBC 2 Biomanufacturing Laboratory Manual Adopters Mount Wachusett Community College (BMS is biomanufacturer partner) Minuteman Regional High School Adult Evening Program (Shire is biomanufacturer partner) Hudson Valley Community College (Regeneron is biomanufacturer partner) Great Bay Community College (Lonza and Stryker are biomanufacturer partners) Montgomery County Community College Hagerstown Community College

11. ‘Protein is Cash’ lab manual Overview of Protein is Cash Manual – Metrology – Transformation – Upstream processing – Downstream processing – Qualitative analysis – GMP/Food and Drug Analysis Can be found at: www.biomanufacturing.orgwww.biomanufacturing.org

12. ‘Protein is Cash’ : Adult Certificate Program Biomanufacturing Certificate Program Derived from Protein is Cash and Global Manufacturing Curriculum 12 week course 2 hours of lectures, 6 hours of laboratory activities per week

13. The Virtual C hromatography Laboratory on the Web URL: http://ATeLearning.com/BioChrom/ Password: hi-tec2011 (lower case)

14. Motivation for developing virtual biomanufacturing laboratories: Provide students of digital generation with visual instructions and learning tools that more relevant to their every-day habits and experience than traditional printed materials Enhance hands-on training Supplement and/or substitute for hands-on training (high school students, where time in the lab is limited, and e-learners) Substitute for or enhancement of printed instructions for hands-on experiments (e.g. - textbooks and user’s manuals may not be necessary) Shorten training time for students and employees Facilitate just-in-time learning to enhance students’ understanding and to create transferrable skills and knowledge. Provide technology and tools for performance-based assessment.

15. Simulation-based Virtual Learning Environment  Simulations  Virtual experiments (self-guided online assignments for students)  Assessment tool  Embedded resources for “just-in-time” learning (Online lessons, presentations, papers, etc.)  Auxiliary resources (glossary, animations …. )

16. Virtual experiment  focuses on a particular task,  students have to follow guidelines Includes: main simulation specific learning objectives scenario/assignment step-by-step instructions for students worksheet assessment optional components: auxiliary simulations, prerequisites, excerpts from interactive lessons and technical manuals, quizzes, and other online reference resources. Simulation  task and learner neutral,  there are no restrictions on user’s actions Target audience: Teachers and instructorsStudents Simulations vs. Virtual Experiments Includes: brief theory help

17. Comprehensive Learning/Teaching Environment Traditional printing curriculum resources (textbooks, user’s manual, worksheets, etc.) Hands-on laboratories Virtual laboratories Remote laboratories Hybrid (blended) laboratories (hands-on & virtual labs, remote & virtual labs) On-line curriculum resources Auxiliary tools (authoring tools for customization of virtual labs and online resources, communication tools (forums, blogs, e-mail, etc.) learning management tools)

18. LP Biologic Chromatography Lab

20. Introduction: Goal: Introduce equipment and to study the design and functionality of main system components. Operation: (auto and step-by-step): Goal: Demonstrate the system operation and major processes. Virtual experiment: Goal: Facilitate an online experiment that exactly match experimental tasks that students face in workplace or in actual college labs. Assessment Goal: Evaluate students’ knowledge and skills APPLICATION MODES:

21. Run Demo Password: hi-tec2011

22. The proposed blended learning cycle recommends a five-step approach to student learning: Learning cycle  Use simulations and online materials to learn the theory and basic principles underlying protein purification;  Use simulations to become familiar with a liquid column chromatography system, its components and their function;  Perform virtual experiment(s);  Evaluate knowledge and virtual skills, using a built-in assessment tool, before granting access to the real chromatography system;  Use the real BioLogic ® LC Chromatography System to purify proteins.

23. Future plans:  Developing new virtual experiments;  Completing the major blocks of this Virtual Liquid Chromatography Laboratory (i.e., Lessons, Assessment, Glossary)  Creating virtual labs and relevant e-learning materials for other subjects;  Thorough testing to evaluate and compare the impact on student learning of hybrid labs versus the separate use of hands-on or virtual labs; You are invited to participate in piloting our Virtual Liquid Chromatography Lab.

24. URL: http://www.atelearning.com/BioChrom Password: hi-tec2011 (lower case)

30. We believe that the combination of online and hands-on learning ensures integration of theoretical knowledge and practical skills and enhances students’ understanding and workplace performance.

31. Dr. Yakov Cherner ATeL, LLC Phone: (781) 842-3300 e-mail: YCherner@ATeLearning.com Web site: http://ATeLearning.com Contact : Dr. Sonia Walman NBC 2 e-mail: swallman@biomanufacturing.org Web site: http://Biomanufacturing.org