Rhode Island Hub

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Rhode Island Hub

• Upstream/Downstream
• Manufacturing
• Josephine Pino
• Director, RI Hub

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4 campus system with 4 satellite campuses

• Knight Campus
• Biotechnology Certificate
• Chemical Technology
• Process Control Technology

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A Snap Shot Sept. 1, 2005 at the RI Hub

• 18 credit Biotechnology Certificate Program for
  transitioning workers and experienced students.
• Approximately 20 students enrolled in one or more
  program courses, but only about 3 are
  officially enrolled as Biotechnology students.
• Biotechnology Advisory Board had recently been
  formed, with 8 participating members.
• Nascent partnership with Davies Career and Tech
  High School.
• Good equipment and facilities for teaching
  process control and separation chemistry, basic
  DNA/protein analysis and microbiology.
• Limitations in specific equipment and facilities
  needed for upstream processing and some aspects
  of downstream processing and QC.

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The Program
Biology Department
Orientation to Biotech Cell Biology for
Technology Introductory Biotech Skills General
Microbiology
18 credit CCRI Biotechnology Certificate
Program at CCRI
Engineering and Technology Department Intro to
Instrumentation (Process Control)
Chemistry Department Chemical Technology
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The Faculty

• Richard Cardin Engineering Dept Chairperson and
  Process Control Faculty.
• Josephine Pino Biotechnology Program
  Coordinator and Biology Dept Faculty Member.
• Tom Whitfield - Chemistry Dept Chairperson and
  Chemical Technology Faculty.

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Students

• Typically
• Prior coursework and/or degree in related field.
• Mature
• Transitioning or exploring career options

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Snapshot Today

• Industry partnership has grown.
• More educational partnerships.
• College level approval of A.S. Program. (first
  phase in RI)
• Biomanufacturing equipment identified and
  ordered.
• 1 small prep area has been dedicated for grant
  work plus plan for dedicated teaching laboratory
  in Fall, 06.

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Learning Community

• 14 Industry Partners from

• Amgen
• Chisolm Corp.
• Ethide Labs
• GG Technologies
• Microtest Labs
• NeurotechUSA
• Pfizer
• Rena Med Biologics
• Spherics
• RI Tech Collective
• Human Genetic Therapies

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Secondary Education Partners
Learning Community

• RI Department of Education Biotechnology
  Initiative
• William Davies Career Technical Institute
  Dana Hopkins, an NBC2 participant

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Higher Ed. Partners
Learning Community

• University of Rhode Island
• Professors Albert Kausch, Greg Paquette
• Bristol Community College (Fall River, Mass.)
  Dean Vijay Raja

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Other Partners
Learning Community

• RI Workforce Partnership
• H1B tuition support grant
• RI INBRE - Biomedical Science network -
  internships, tours for students
• RI EPSCoR statewide Life Science network.
• EPSCoR NSFs Experimental Program to Stimulate
  Competitive Research

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Overlap between EPSCoR and NBC2 goals
Learning Community

• Equipment budget for CCRI to train biotech
  students
• UV/Vis spec, Inverted microscope, TFF system,
  Shaking incubator, Platform shaker, BioDocIt
  Imaging system
• Communication network in RI
• Outreach to 9-12 students and teachers via
  Outreach Center located at CCRI.
• Opportunities for students (internships,
  seminars, etc)
• Access to shared resources

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NBC2 Equipment on the way
Equipment and Facilities

• BioFlow 110 Advanced Fermentation Kit
• Eppendorf Refrigerated Benchtop Centrifuge
• Bio-Rad LP chromatography system w/software
• NuAir Biosafety Cabinet
• Dell desktop computer
• BioTekElx 800 Universal Microplate Reader

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Process Control Lab
Equipment and Facilities
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Chemical Technology Lab
Equipment and Facilities
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New Space in progress.
Equipment and Facilities

• Small lab for NBC2 equipment and lab assistant,
  C. Befumo, to work with J.Pino on curriculum
  materials development.
• Reorganization of Biology Dept lab space to
  enable dedication of one teaching lab to
  Biotechnology instruction.

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General Roles and Activities
Josephine Pino NBC2 Grant director at RI hub,
liaison to learning community, upstream
processing (all cell types), develop A.S.
curricula w/biomanufacturing capstone
course. Richard Cardin Process control in
upstream and downstream biomanufacturing Thomas
Whitfield Downstream Processing Christina
Befumo Laboratory Assistant Dana Hopkins high
school outreach, curriculum materials development
during summer (will also teach at CCRI)
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Process Control Activities

• Professional development validation/GMP
  workshop, tours, etc
• Lecture materials integrating biomanufacturing
  with process control instrumentation
• Adapt curricular materials to take into account
  biotechnology-specific documentation
  requirements.
• Next
• Tours, visits to industry to learn more
• Continue building linkages between curricula (use
  of case studies)
• Eventually develop specific SOPs for process
  control of biomanufacturing training equipment
  (eg. Bioreactor)

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Downstream Processing Activities

• Professional development via ISPE, ACS, tours,
  etc.
• Developing teaching materials for ion exchange
  chromatography separation of proteins.
• Next
• With arrival of equipment SOPs for BioRad LP
  chromatography system and filtration.

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Upstream Processing Activities

• Current
• Procuring equipment by NBC2 funds, EPSCoR
  involvement, donation requests, etc.
• Planning procedures, cell types, supply
  purchases, addressing problems and plans for
  adapting.
• Professional development via tours, ISPE events,
  etc.
• Lecture, lab teaching materials for basic skills
  (eg. media prep) and GMP
• Next
• With arrival of equipment SOPs for cell
  maintenance, scale up and production.
• Work with microbiology faculty to develop
  biomanfuacturing-related curricular materials for
  microbiology course.

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Program Expansion at CCRI

• Dec. 2005- CCRI approval of a two-track A.S. in
  Biotechnology (state-level approval is next step)
• Highlights of the proposed A.S. curriculum
• Year 1 - prerequisite science, plus intro to
  biotechnology, process control and chem tech
  skills.
• Year 2 - Molecular Biology, Biomanufacturing
  Capstone, and Seminar on Biotechnology Industry
  Topics

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Proposed Modules in Biomanufacturing Course

• Introduction to Biomanufacturing
• ?Review of scientific foundations of the field
  Recombinant Technology, Host Cell Features, and
  Protein Chemistry
• ?Drug Development
• ?Introduction to the Industry itself (types of
  companies, roles, structure of a typical company
  )
• ?GMP and Regulatory Considerations
• ?Equipment Validation Installation
  Qualification and Operational Qualification
• Principles and Techniques of Upstream Processing
• ?Introduction to host cells biology and tissue
  culture
• ?Culture of bacterial,fungal and mammalian cells
• ?Cell quantification
• ?Process controlled batch fermentation of
  recombinant cells
• Principles and Techniques of Downstream
  Processing
• ?Introduction to QC techniques HPLC, bioburden,
  conductivity, pH
• ?Filtration
• ?Product Purification by ion exchange or affinity
  purification
• ?SDS-PAGE. Isoelectric Focusing analysis of
  product

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A.S. in Biotechnology Note this has not yet
been approved by RI Board of Governors
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A.S. in Biotechnology Note this has not yet
been approved by RI Board of Governors
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Predicted Curricular Impact of A.S. Program
Approval

• Provide opportunity to teach upstream/downstream
  and other job skills in one course
• Integration of GMP with upstream/downstream
  skills training.
• Better, more consistent preparation of students
  entering biomanufacturing course.
• Students will have a better opportunity to see
  how biomanufacturing is related to RD and
  regulatory systems.
• Students will be more marketable to employers!

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Converging Technologies

• Take existing technology training capabilities in
  chemistry, engineering and biotechnology.
• Adopt new technologies and training capabilities.
• 3. Merge these to address biomanufacturing
  training needs.

upstream
downstream
Process control