Web-Based Virtual and Hybrid Laboratories for Biomanufacturing Curriculum

Web-Based Virtual and Hybrid Laboratories for Biomanufacturing Curriculum Sonia Wallman, Ph. D NBC 2 swallman@biomanufacturing. org Yakov Cherner, Ph. D ATe. L, LLC ycherner@atelearning. com

f. P rod uct s Global Bio. Manufacturing Curriculum Co mp let e. S uit eo Virtual On Labs Support 0 l 201 ok Fal line Textb o Labo rator BIOM y AN uals Man e nlin O

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

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 Quality • Quality Assurance Production • Upstream Processing Cynthia Sarnoski, Frank Hallinan, Pfizer Ron Hudcosky, Merck Olga Mollin, Jane Flanagan, John Hasyn, MCCC Paul O’Neil, Pall Euroflow Lonza • Downstream • Microbial Control Processing • QC Biochemistry Mary Harne, Zhenhong Lee. , HGSI • Process Development Ezster Birck Wilson

Biofuels Curriculum

Biofuels Textbook

Biofuels Lab Manual

Laboratory Manuals § Generic § Custom § CHO – t. PA § Pichia pastoris - HSA § Protein is Cash

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

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

‘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. org

‘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

The Virtual Chromatography Laboratory on the Web URL: http: //ATe. Learning. com/Bio. Chrom/ Password: hi-tec 2011 (lower case)

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.

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

Simulations vs. Virtual Experiments Simulation Ø task and learner neutral, Ø there are no restrictions on user’s actions Virtual experiment Ø focuses on a particular task, Ø students have to follow guidelines Includes: • • • Includes: • brief theory • help 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. Target audience: Teachers and instructors Students

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

LP Biologic Chromatography Lab

APPLICATION MODES: 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

Run Demo Password: hi-tec 2011

Learning cycle The proposed blended learning cycle recommends a five-step approach to student learning: ¨ Use simulations and online materials to learn 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 Bio. Logic® LC Chromatography System to purify proteins.

Future plans: ¨ Completing the major blocks of this Virtual Liquid Chromatography Laboratory (i. e. , Lessons, Assessment, Glossary) ¨ Developing new virtual experiments; ¨ 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.

URL: http: //www. atelearning. com/Bio. Chrom Password: hi-tec 2011 (lower case)

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.

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