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New York Hub EHS Focus

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New York Hub EHS Focus

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    1. New York Hub EH&S Focus

    2. The New York Hub A profile of our institution and our programs Overview of hub collaborators Biomanufacturing along the I-90 Health Sciences Corridor The Environmental Health and Safety Curriculum and Action Plan

    3. FLCC and the New York Hub

    5. A.S. Biotechology Gateway courses (BIO I and II, CHM I and II) Advanced (Cell, Micro, Genetics) Techniques (Genetics lab, Bacteriological, Electrophoresis, Genetics Research/PCR, Cell and Tissue, Spectrophotometric, Plant microprop) Transfer (Organic I,II; Calc I level of math) Credits: 67 minimum (Algebra/Pre-calc sequence) 68 recommended (Pre-calc/Calc I sequence) 73 for transfer (inclusion of Organic I and II)

    6. Principles of Biomanufacturing

    9. Danisco acquired Genencor in 2005 Dansico becomes the second largest supplier of industrial enzymes in the world. The Rochester Center for Development and Commercialization (RCDC) – enzymes The Rochester Therapeutics Production Center (RTPC) – cGMP biopharmaceuticals – Health Care Division

    10. Celltech - North American commercialization and manufacturing center 40-acre site includes 400,000 sq. ft. of modern manufacturing space Biopharmaceuticals for treatment of Attention deficit hyperactivity disorder (ADHD) Obesity Respiratory diseases Bronchitis, and allergic rhinitis

    11. 90 plus acre campus. large volume fermentation manufacturing world-class chemical and biotechnology development laboratories pilot and commercial manufacturing plants pharmaceutical research laboratories. Expansion Plan – “Project Hummingbird”

    12. John Tabor, Ph.D. - Vice President Global Biotechnology and Third Party Manufacturing Strategy Steven Lee, Ph.D. - Senior Director, Syracuse Biotechnology Development and Operations Kirk Leister, Ph.D. - Director Analytical Biochemistry Michael Munster, Ph.D. - Director Biologics Quality Assurance and Quality Control, Syracuse Tom Vanden Boom, Ph.D. - Director, Biotechnology Development Alan Berry, Ph.D. - Director, Bioprocess Development Les Mintzmyer - Director Syracuse Biotechnology Manufacturing Operations John Hickey - Group Leader, Syracuse Biologics Project Management Sallie Bittner - Director of Human Resources, Syracuse Dave Lapinski - EHS Associate Director, Third Party Manufacturing/In-Licensing Programs.

    13. CAS LLC Alzheimer’s disease therapies. Koning Corporation 3-D visualization of breast tumors. LAGeT Inc. gene therapy in musculoskeletal indications. OyaGen Inc. HIV therapeutics. Pathologics Inc. biological diagnostic systems. RTek Medical Systems LLC prostate cancer therapy. Socratech LLC diagnostic and therapeutic approaches to Alzheimer’s disease. Vaccinex Inc. therapeutic antibody discovery. VirtualScopics LLC’s CT scans conversion into 3-D color images. URMC “engine running”

    14. The prototypical Rochester biotechnology company URMC spin-off proprietary ACTIVMAB antibody discovery technology library-based antibody discovery technology Express complete, fully functional antibodies in mammalian cells Antibody therapeutics Product pipeline C35 for breast cancer, BVX-10 for inflammation, BVX-20 for oncology Long-range view of manufacturing “in house.” 33,000 sq. ft. Rochester facility employs 46 individuals $32 million in venture and $10 million in grants

    15. EHS Curriculum Pre-requisites Math skills: up to, and including college-level algebra Basic computer skills (Word, Excel, PowerPoint) A basic understanding of chemical principles concentration expressions, pH, acids, bases, buffers)

    16. Core “platform” Principles Knowledge of EHS documents and various forms of documentation A survey of the various standards applied by EHS professionals. An understanding of all of the ways that hazards are communicated to employees in the biomanufacturing environment. Understanding permits: reading, designing, and utilizing permits Understanding of waste streams, recycling, and Hazardous Waste Operations (HAZWOPER) Accident Investigation and principles of accident investigation (root cause analysis)

    17. A focus on regulations Hazardous material management (EPA, State Environmental Agencies) Hazard communication (OSHA) Spill Prevention (EPA, State Environmental Departments) Process safety (OSHA) Wastewater regulations (EPA, State Environmental Agencies) Ergonomics (OSHA) How to read write and utilize safe work permits, confined space permits (OSHA) Lock Out Tag Out (LOTO) standards and procedures (OSHA) Hazard Communication (OSHA) HAZWOPER – Hazardous Waste Operations and Emergency Response (OSHA, EPA, State Environmental Agencies, DOT) Means of Egress (OSHA)

    18. Pedagogical Approach The pedagogical approach will utilize a combination of case studies and hands-on activities. The case studies will create the context for the hands-on activities and will provide the core critical thinking challenges.

    19. Case #1: Confined Spaces Confined Space Entry Scenario Utilize a Standard Operating Procedure as part of a simulated CSE Program Calibration and utilization of gas monitoring instrumentation Lock-out/Tag-out activity Working with safety permits

    20. Case #2: HAZWOPER Program Hazardous Waste Operations and Emergency Response develop a basic HAZWOPER program for a new biomanufacturing facility (their college). students will explore the elements of existing plans Learn how HAZWOPER is the intersection of three Federal regulatory agencies (EPA, OSHA, DOT). Explore the two main objectives of HAZWOPER Operations: Control or eliminate the potential hazards and/or losses. Protect the health and safety of workers, the public, and the environment.

    21. Case #3: Accident Investigation Employ accident investigation techniques to help determine the cause of the accident (root cause analysis). Interrupted case method will be applied simulates the collection of information and analysis of data collected during the investigation. Students will then be challenged with the task of producing an investigation of their report in a specified format.

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