Northeast Biomanufacturing Center and Collaborative (NBC2) by HC120425215612

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									           Northeast Biomanufacturing Center and Collaborative (NBC2)
                    Northern New England Hub Annual Report
              Job Foci: Facilities, Metrology, and Process Development
                                      2005-2007

                                     Introduction

        Created in 2005 by a grant from the National Science Foundation (NSF)
Advanced Technological Education (ATE) program (NSF #05019530), the goal of the
Northeast Biomanufacturing Center and Collaborative (NBC2) is to form a self-sustaining
alliance of community colleges working in collaboration with industry, education,
professional associations and government to prepare a 21st century workforce for the
biomanufacturing sector of the biotechnology industry. NBC2 will supply skilled
professional for Northeastern biomanufacturing companies and an educational pathway
for success in the biomanufacturing industry from high school to community colleges to
universities.
        The focus of this report is the progress the Northern New England Hub is making
relative to the center’s primary objectives.

Northern New England Hub Staff

        Serving as Hub Director for the Northern New England Hub of the NBC2 is Dr.
Sonia Wallman, Professor of Biotechnology and Director of Biotechnology at New
Hampshire Community Technical College. Dr. Wallman is also Director and Principal
Investigator (PI) for the NBC2.

       Working along with Dr. Wallman at New Hampshire Community Technical
College’s Biotechnology Department is Deb Audino, Associate Professor of
Biotechnology/Biomanufacturing; Robert O’Brien, Biomanufacturing Laboratory
Manager; Susan Harvey, Administrative Assistant; Tim Dubuque, Webmaster and
Multimedia Specialist; David Miller, Professor of Internet Systems Technology; Kari
Britt and Hope Townes, Laboratory Assistants.

New Hampshire Community Technical College (NHCTC) Biotechnology Program

        NHCTC’s Biotechnology program with a Biomanufacturing focus has been in
operation since Fall 1994 when the first round of NSF ATE grants provided funds to
equip a Biotechnology lab with a Biomanufacturing focus. Two equipment, process and
regulatory “rich” 160 hour cornerstone courses to the biotechnology industry were
developed as a result of this grant: Discovery Research and Biomanufacturing. These
courses are the focus of NHCTC’s “nested” Biotechnology Certificate, Academic
Certificate and Associate in Science degree. The Biotechnology A.S. degree has been set
up so that it is 100% transferable to four year colleges and universities.




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NBC2 Objective #1: Establish sustainable learning communities around community
college hubs.

Hub partners

    Academic collaborators (High School, 2-year/4-year College Program
     Directors/Coordinators):

              Carolyn Kelley, Biotechnology Coordinator, Seacoast School of
               Technology, Exeter, NH
              Ken Franson, Kingswood Regional High School, Wolfeboro, NH
              Rich Parent, Biotechnology Coordinator, Milford High School, Milford,
               NH
              Ann Gnagey, Director of Biotechnology, Vermont Technical College,
               Randolf Center, VT
              P.T. Vasudevan, Professor of Chemical Engineering, University of New
               Hampshire, Durham, NH

    Industry collaborators:

              Michael Cicio, Senior Director of Biomanufacturing, Lonza Biologics,
               Portsmouth, NH
              Bill Piombino, Director of Facilities and Engineering, Lonza Biologics,
               Portsmouth, NH
              Ron Newsome, Facilities, Lonza Biologics, Portsmouth, NH
              John Rafuse, AIA, Architectural Design and Planning, Meredith, NH
              Rich Yeaton, Director, East Coast Validation, Derry, NH
              Stephen Jerge, Calibration Supervisor, Lonza Biologics, Portsmouth, NH
              Andy Clark, Metrology/Facilities Supervisor, Stryker Biotech, West
               Lebanon, NH
              Margaret Worden, Director of Manufacturing Sciences, Stryker Biotech,
               West Lebanon, NH
              Eugene L. Lambert, Principal Engineer, Wunderlick-Malec, Portsmouth,
               NH
              Jeffrey Robinson, Senior Process Development Scientist, Lonza Biologics,
               Portsmouth, NH
              Paul O’Neil, Director of Chromatograpy Techniques, Pall Euroflow,
               Portsmouth, NH
              Jennifer Griffin, Application Specialist-Chromatography, Pall Euroflow,
               Portsmouth, NH
              Jennifer Murphy, Senior Process Technician, Wyeth Biopharma, Andover,
               MA
              Marc D’Anjou, Fermentation Group, GlycoFi, Lebanon, NH
              Michael Paglia, Manager of Research, Manufacturing and Process
               Development, TolerRX, Cambridge, MA


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    State and Local Government Organizations:

              Paula Newton, President, New Hampshire Biotechnology Council,
               Portsmouth, NH
              Marie Cappello, Executive Director, Rockingham Economic Development
               Corporation, Exeter, NH

Learning Community Meetings:

       Much of the initial interaction with the Northern New England Learning
Community relative to the development of instructional materials and resources to
support Facilities, Metrology, and Process Development was done “virtually” through
phone calls and e-mails to specific individuals.

         Dr. Sonia Wallman is overseeing the development of instructional materials and
resources to support the facilities technician job. A facilities sub-group consisting of
Sonia Wallman, John Rafuse and Rich Yeaton met several times during the year to flesh
out the scope of operation and design of a small pilot plant to be built beside the current
New Hampshire Biotechnology Education and Training (NH BET) Center at NHCTC.
The NH BET Center occupies one half of a 10,000 square foot warehouse that is part of
NHCTC’s Portsmouth campus on the Pease International Tradeport and the NH Pilot
Plant will occupy part of the other half of the warehouse. It should be noted that this
facility is just down the street from Lonza Biologics and Pall Euroflow, also on the Pease
International Tradeport. Both of these corporations will be major partners in equipping
the pilot plant after its construction and Lonza will most likely make use of the facility.
Current plans for the NH Pilot Plant call for the use of wave technology with its
disposable cell culture bags and disposable biomanufacturing equipment, such as
membrane filters for chromatography and tough plastic bags for storing buffers, media,
and product. Certain pieces of permanent equipment will also be used including a
biosafety cabinet and a centrifuge. A block diagram and architectural drawings of the
2,400 square foot NH Pilot Plant with associated mechanical room are appended to this
document. Future plans for 2006-2007 include the involvement of Lonza and Pall
Euroflow in finalizing the design and use of the pilot plant and on working on funding for
the NH Pilot Plant. Construction of the pilot plant will coincide with the reconstruction
of NHCTC’s Portsmouth campus which should begin in Spring 2007 and should be
finished by Fall 2009.

       Robert O’Brien is overseeing the development of instructional materials and
resources to support the instrumentation/calibration (metrology) technician job. He is
working predominantly with NHCTC’s David Miller and seeking input from metrology
professionals from Lonza and Stryker.

       Deb Audino is overseeing the development of instructional materials and
resources to support the process development job. Process development instructional
materials will focus on a system which we established in 1994-1995 with the help of a
UNH student pursuing a Master’s degree in Biochemistry, Rachael Kroe. This is the


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Pichia pastoris-HSA (human serum albumin) Core Production System that we teach as
one of three core production systems utilized in NHCTC’s Biomanufacturing course.
Kari Britt will be helping to develop the process development instructional materials, in
particular the scale up of the HSA purification process from a 25mL column to a 2L
column.

        We have had several Learning Community meetings at NHCTC’s Portsmouth
campus including a meeting focused on Process Development with Jeff Robinson from
Lonza Biologics who gave us a great overview of process development; numerous
meetings with John Rafuse, AIA and Rich Yeaton, President of East Coast Validation
Services on the design of a 2,400 square foot Pilot Plant utilizing disposables for
upstream and downstream processing. In addition we have had two meetings of our
Advisory Board, in November 2005 and 2006 that included representatives from
industry, government and education; introduction of apprentices and students looking for
jobs after December graduation.

NBC2 Objective #2: Develop biomanufacturing curricula and instructional materials

Facilities
        A case study of the construction, equipping, commissioning and qualification of a
cGMP facility will be used as the basis for biomanufacturing education and training on
Facilities. Documentation of the design, construction, equipping, commissioning and
qualification of the NH BET Pilot Plant at New Hampshire Community Technical
College (NHCTC) will be used for the Case Study. The latest design for the facility is
attached to this document.

        Bill Piombino and Ron Newsome at Lonza, will help pinpoint what a Facilities
professional actually does on a day to day basis such as managing the HVAC systems,
production of WFI water and clean steam and provision of gases. SOPs for handling
these systems will complete the Facilities education and training package.

       PRE-REQUISITES:

    Prior to enrolling in courses and/or modules for Facilities, students will be expected
to have:
     English literacy
     Math skills: applied math, college level algebra, statistics
     Word processing, spreadsheets, familiarity with CAD
     Communication skills, interpersonal skills, organization skills
     Ideally, the facilities technician would come to training in biomanufacturing from
        a community college HVAC program, but everyone will benefit from some
        knowledge on facility construction and maintenance.




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EQUIPMENT:

     Equipment needs for the SOPs will be determined after SOP content has been
      identified.

      KNOWLEDGE NEEDED BY FACILITIES TECHNICIANS:

     General understanding of safe handling, transport and storage of biological and
      chemical materials; handling of hazardous waste; lock-out/tag-out; fall protection;
      confined space entry; personal protective equipment; safety audit purpose and
      procedures; OSHA regulations; disinfection and sterilization methods
     General understanding of environmental regulations and plant waste processing
      systems
     General understanding of cGMP principles, procedures and vocabulary including:
      batch records, basic data recording practices, change control, deviation control,
      SOP writing, understanding and working from SOPs, consequences of non-
      compliance
     General understanding of validation principles
     Principles and practices of commissioning and qualification
     Knowledge of typical types of documentation related to facilities and equipment:
      maintenance logs, calibration certificates, out of tolerance reports, and installation
      reports
     Water-types typically used in pharmaceutical operations: DI, WFI, USP
     Chilled water
     CIP solutions
     Steam and clean steam; SIP systems
     HVAC (particle counts, classifications)
     Instrument and process air
     Other gases
     Electrical systems/power distribution
     Waste collection and processing systems
     Working knowledge of P&ID symbology
     Ability to verify equipment location/installation using P&IDs
     Ability to redline P&IDs appropriately
     Working knowledge of common types of pumps, piping, tanks, valves, agitators,
      heat exchangers, and solids handling equipment used in bioprocess manufacturing
     Principles of piping and pump sizing
     Characteristics of materials used in pumps, piping, tanks and valves
     Pipefitting: fabrication, welding and passivation, and sanitary piping installation
     Operational understanding of instrumentation for monitoring common process
      parameters: flow, level, temperature, pressure, mass, pH and DO
     Operational understanding of process control systems
     Statistical process control and trending analysis
     Operational knowledge of the calibration of process instrumentation
     Basis principles of cleanroom work, laminar flow hoods, and gowning procedures


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      Repair and maintenance of equipment and systems listed above or their
       components including: valves, actuators, agitators, fans, bearings, couplings, belt
       drives, mechanical seals, hoists, hydraulic and pneumatic equipment, electrical
       and pneumatic control circuits and actuators
      Familiarity with select unit operations, processing equipment, and flow of unit
       operations
      Chemical testing of steam and cooling water systems
      Predictive technologies (vibration analysis, laser alignment)

       TOPICS TO BE COVERED BY FACILITY SOPs:

      Principles and practices of commissioning and qualification
      HVAC (particle counts; classifications)
      People and materials flow
      Gasses
      Water: DI, WFI, USP, chilled water
      Waste Handling (Kill Tank Operation)

       DESIGN OF PILOT PLANT USING DISPOSABLES (see Power Point Slides)

Metrology

        The curriculum will be divided into several modules that can be incorporated into
a biotechnology course as well as being used stand alone. All modules will require
students to follow and modify in some cases existing Sops. The pipette module will
cover basics component of pipette the use leak down and calibration accuracy. The
Module on metrology and Calibration will the basics terminology, documentation, cover
FDA guidelines along with how ISO fits into the big scheme. The Balance module will
cover electronic balance measurement and calibration of top loading balances. Air
sampling Module will cover the basics of the air sampler calibration showing the
atmospheric condition flow rate and calculation floats height. Examples of Certificate of
calibration along with the documentation control systems will need to disseminate. The
Air ampler module will cover operation and calibration of an air sampler. Lecture
material such as power point presentations will be created. Video technology may be
utilized. Understanding the designing of a calibration system, that will support tracking
and reporting for equipment calibration records. An understanding pipette, top loader
balance, and air sampler calibration procedures and theory. Another set of resources
published by the International Society of Pharmaceutical Engineers (ISPE) GAMP Good
Practice Guide Calibration Management will also be utilized.

        OBJECTIVES:
        The following principles will define the core objectives of the Metrology
curriculum:
     Demonstrate an understanding of the role of the Calibration / Metrology and the
        relationship to the other departments in the organization.



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   Demonstrate the ability to read, follow and revise calibration SOPs as well as to
    write initial release calibration SOPs.
   Hands on labs for the pipette, top loader balance and Air Sampler are to be
    developed.
   The importance of repair and preventative maintenance of equipment the
    importance of basic data recording practices, change control, deviation control.

    TOPICS TO BE COVERED BY METROLGY SOPs:

    INTRODUCTORY MODULES for Metrology Calibration
   Systems approach
   Principles of calibration
   Documentation / Standards organizations such as ISO and FDA guidelines and 21
    CFR Part 211 and GAMP
   Develop calibration management system defining Features and purpose
   Measurement uncertainty analysis for the laboratory accuracy and precision
   General understanding of validation principles
   Gravimetric method
   Preventive Maintenance Regimes vs. Corrective Maintenance
   Learn traceability, qualification, and validation principles
   Terminology and appropriate training materials

    Balance Calibration All completed
   Development of operation al SOP and appropriate training materials
   Develop calibration SOP and appropriate training materials
   Development of a maintenance SOP
   Electronic Balance calibration and appropriate training materials
   Terminology and appropriate training materials

    Autoclave monitoring All completed
   Develop Sop for the monitoring of autoclave sterilization
   Develop the relationship between preventive maintenance and calibration
   Development of documentation work forms
   Development of training materials

    Air Sampler Calibration Written , developed training material
   Development of operational SOP and appropriate training materials
   Develop calibration SOP and appropriate training materials
   Terminology and appropriate training materials

    Pipette Calibration Written , developed training material
   Development of operational SOP
   SOP for leak down testing
   Inspection criteria disassembly assembly SOP
   Development of pipette accuracy calibration utilizing a kit


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      Develop calibration management system
      Terminology

Process Development

    The curriculum will be divided into several modules that can be incorporated into an
existing biomanufacturing course or can be used as a stand alone process development
course. All modules will require students to follow and possibly modify existing SOPs.
The upstream modules will have the students follow SOPs designed to demonstrate how
to improve upstream processing, specifically media design and growth conditions in a
bioreactor. The downstream modules will involve evaluating different small scale
chromatography conditions such as bead (ion exchange, affinity and hydrophobic
interaction) and buffer selection. Each of the types of columns will be utilized on a small
scale (~10ml), separately at first and then in different combinations to design an optimal
purification scheme. It will also include a module on chromatography scale-up from a
25mL to a 2L column. HSA protein generated from the Pichia pastoris core production
system will be used. Lecture materials such as powerpoint presentations will be created.
Videos may be utilized.

      OBJECTIVES:
      The following principles will define the core objectives of the Process
Development curriculum:
    Demonstrate an understanding of the role of the process development scientist
      and their relationship to the other departments in the organization
    Demonstrate the ability to read, follow and revise SOPs, as well as to write initial
      release SOPs
    Develop an increased understanding of the importance of media formulation
    Develop a proficiency in running bioreactors and modifying growth conditions
    Develop an understanding of how to select the appropriate type of bead and buffer
      for chromatography
    Develop an understanding of how to scale-up chromatography processes

       PRE-REQUISITES:
       Prior to enrolling in courses and/or modules for process development, students
       will be expected to have:
       Good written and verbal communication skills
       Math skills: college level algebra
       Basic computer skills (Word, Excel, Powerpoint)
       General Chemistry
       General Biology

       EQUIPMENT NECESSARY TO SUPPORT CURRICULUM DEVELOPMENT
          100ml spinner flasks
          Process controlled bioreactor(s)
          Wave bioreactor
          Analyte Analyzer (Biolyzer or Nova BioScience)


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             Microscope for cell counts
             BioRad DuoFlow Chromatography System
             Peristaltic pumps
             Large scale (2L) chromatography column (Millipore Vantage)

       TOPICS TO BE COVERED BY PROCESS DEVELOPMENT SOPs

       UPSTREAM MODULES
       Media Formulation
           Evaluating various commercial serum free media
       Upstream Processing
           Evaluating disposable systems such as Wave Technology vs. bioreactors
           Evaluating batch vs. fed-batch vs. perfusion cell culture
           Optimizing perfusion cultures

       DOWNSTREAM MODULES
       Chromatography Conditions
           Bead selection
           Buffer optimization (composition, pH, conductivity)
           Packing optimization including factors that influence column efficiency,
             HETP and peak symmetry
           Sample volume
           Flow rate optimization
           Cleaning and regeneration optimization
       Chromatography Scale-Up
           Column dimension optimization
           Column packing optimization
           Sample volume optimization
           Flow rate optimization
           Cleaning and regeneration optimization

NBC2 Objective #3: Provide professional development opportunities in
biomanufacturing for faculty

       Deb Audino took the following week long short-course at Pennsylvania State
University: Animal Cell Culture and Scale-Up Strategies during Spring 2006.

       Sonia Wallman, Deb Audino and Robert O’Brien observed scale-up of
mammalian cell cultures and QC Microbiology operations at Lonza Biologics during July
and August 2006. An 8 hour custom course in Aseptic Awareness was build for Lonza
employees that includes behavioral videotaping of each employee as they perform aseptic
processes in a biosafety cabinet.




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       Deb Audino, Robert O’Brien, and Kari Britt have been delivering the Aseptic
Awareness course since October 2006. Lonza has asked us to train about 200 of their
production and quality control staff; we have trained about 100 thus far.

NBC2 Objective #4: Disseminate biomanufacturing education, training and
workforce information

Conferences and Workshops

       Advancing Innovations in Engineering Technology Education in San Diego,
November 2-4, 2005
       Dr. Wallman attended this interesting conference and used the conference
organization structure for BIOMAN 2006. Dr. Wallman also was able to link with other
NSF ATE Centers that focus on manufacturing at this conference.

        First Annual Pacific Rim Conference on Industrial Biotechnology, Honolulu, HI,
January 11-16, 2006
        Dr. Wallman attended this conference and presented a poster on the NSF ATE
Northeast Biomanufacturing Center and Collaborative and the DOL Center of Expertise
in Biomanufacturing. From this meeting, it was clear that our focus on hands-on
Biopharmaceutical Biomanufacturing, will give our students the competencies,
knowledge and attributes to cross-over into the many possible realms of Industrial
Biotechnology to support the world-wide biobased economy, including the
biomanufacture of ethanol from corn or cellulosic by-products; and enzymes to support
the textile and pulp and paper industry and so forth.

        National Visiting Committee Meeting, March 2-3, 2006 in Portsmouth
        Dr. Sonia Wallman and the NHCTC biotechnology faculty and staff hosted the
NVC meeting which started with a reception and dinner on March 2nd and was followed
by an all day meeting on March 3rd. The following National Visiting Committee
members were attended the all day NVC meeting: Jim DeKloe, Robert McKown, Jose
Hanquier, Karen Jaeger, Joanna Kile, and Mary Schwalen. Absent were Stephan Kurtzer
(traveling) and Cynthia Sarnoski (family).
        NBC2 Director, Dr. Sonia Wallman, led the meeting and made a presentation on
the Northeast Biomanufacturing Center and Collaborative’s progress from the start of the
grant September 1, 2005 until February 28, 2006. Presentations from the New England
Hub re: Action Plans for Facilities, Metrology and Process Development were made by
Dr. Wallman and Robert O’Brien.

       League for Innovation in the Community College, March 19-22, 2006 in Atlanta
(funded by the DOL ETA National Center for the Biotechnology Workforce)
       Dr. Wallman made a presentation with the Department of Labor funded National
Center for the Biotechnology Workforce which highlighted the regionalization of the
Biomanufacturing Apprenticeship through the NSF ATE Northeast Biomanufacturing
Center and Collaborative (NBC2). Each Hub of the NBC2 is working with




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biomanufacturers nearby to expand the Biomanufacturing Apprenticeship throughout the
Northeast.

        BIO 2006 in Chicago
        Dr. Wallman organized the third annual Council of Biotechnology Centers
Community College program on the Sunday of the start of the annual Biotechnology
Industry Organization meeting in Chicago. The all day event featured Dr. Gerhard
Salinger speaking about the NSF ATE program and Gay Gilbert speaking about the DOL
ETA high job growth training initiatives and two sessions each of NSF ATE and DOL
ETA grantees. There were 85 registered attendees and a dozen walk-ins for a total of
nearly 100 attendees. We are now planning for the same event for BIO 2007 in Boston.
This time the sponsor will be the Biotechnology Institute.
        The Battelle Institute prepared a publication for the Biotechnology Industry
Organization that was unveiled at BIO 2006. In the area on “Specialized postsecondary
programs”, New Hampshire Community Technical College’s Industrial Biotechnology
Education and Training program was featured as one of two states to establish and
expand programs to train workers for careers in biomanufacturing. Three recent grants to
NHCTC were highlighted: the High Growth Job Initiative Department of Labor grant to
create the “Center of Expertise in Biomanufacturing”, part of the National Center for the
Biotechnology Workforce; the National Science Foundation Advanced Technological
Education regional center grant, “The Northeast Biomanufacturing Center and
Collaborative: Building a Sustainable Infrastructure for Biomanufacturing Jobs and
Education”; and a Department of Labor Community-Based grant, “bioCONNECTnh” to
build the biotechnology/biomanufacturing education and training infrastructure in New
Hampshire.

        Hub Directors’ Annual Retreat in Queenstown, Maryland, June 2-4, 2006
        This first annual retreat of the Hub Directors (with Deb Audino and John Grady in
attendance, as well) was very successful. During the two day and two evening meeting
the following activities were accomplished:
                     Developed metrics for evaluating center activities
                     Discussed concept of offering a Global Biomanufacturing
                       Curriculum (GBC)
                     Built a 3 hour lecture/3 hour laboratory (4 credit) course based on
                       the ten job categories
                     Planned for Year 2
                     Began to discuss options for NBC2 sustainability

       International Society of Pharmaceutical Engineers (ISPE) Washington
       Conferences in Arlington, VA, June 5-6, 2006
       Dr. Wallman and Jeff Odum of ISPE put together a two day conference on
Academic Pilot Plants for this annual meeting of ISPE in Arlington, VA. Dr. Wallman
both Chaired the conference and presented on the NH Pilot Plant.




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        Department of Labor’s Eastern Seaboard Apprenticeship Conference: “Hot Jobs
        – Cool Careers” in Atlantic City, June 27-28, 2006 (funded by the DOL ETA
        National Center for the Biotechnology Workforce)
        Dr. Wallman reported on the Biomanufacturing Apprenticeship program
developed under a high growth job training initiative grant to create the National Center
for the Biotechnology Workforce (NCBW). Five community colleges focus on specific
sectors of the biotechnology workforce and NHCTC is the Center of Expertise in
Biomanufacturing for the NCBW.

       Department of Labor’s Workforce Innovations Conference in Anaheim, July 10-
13, 2006 (funded by the DOL ETA National Center for the Biotechnology Workforce)
       Dr. Wallman, and NHCTC Biotechnology A.S. degree program
Biomanufacturing Apprentice, Katrice Jalbert presented as part of a panel entitlted,
Biotech as an Economic Driver. Other presenters included Laura Ginsburg, Office of
Apprenticeship, U.S. Department of Labor-ETA; Russ Read, Executive Director of the
National Center for the Biotechnology Workforce; and an Intern at Forsyth Technical
Community College in Winston-Salem, NC.
       At the same meeting, the NCBW received an honorable mention from Assistant
Secretary of Labor, Emily De Rocco, for “Educating the 21st Century Workforce”.

        BIOMAN 2006 in Portsmouth, NH, July 24-28, 2006 (partially funded by
participants and the DOL ETA National Center for the Biotechnology Workforce)
        This first annual BIOMAN conference was a great success. Scaled-up from
several years of one week workshops, this conference drew 40 participants from sixteen
states and Puerto Rico. An additional 35 folks presented at the conference as Vendors,
Keynoters, Lecturers and Hands-On Workshop Leaders. The conference was deemed a
great success and BIOMAN 2007 will be held next year in Portsmouth, NH from July 23
to 27, 2007.

        Department of Labor Region One Administrator’s Meeting in Portland, ME,
August 1-2, 2006 (funded by DOL ETA National Center for the Biotechnology
Workforce)
        Dr. Wallman presented on the Biomanufacturing Apprenticeship program and the
regionalization of the Biomanufacturing Apprenticeship program the NSF ATE Northeast
Biomanufacturing Center and Collaborative (NBC2), funded in Fall 2005. At this
meeting, Dr. Wallman met the Commissioner’s of Labor for Region One, including the
Commissioner of Labor for Puerto Rico, and expressed an interest in getting together to
help the folks that got one of the DOL’s thirteen virtual WIRED grants.

       Third Latin American and Caribbean Biotechnology Congress in Mayaguez, PR,
September 20-23 and Meetings in San Juan, September 25-27, 2006 (funded by UPR-
Mayaguez)
       Dr. Wallman made a presentation entitled, From Local to Regional to Global:
The Story of the New Hampshire Community Technical College’s Industrial
Biotechnology Program in Mayaguez. In San Juan, Dr. Wallman met with folks from the
Department of Education and the University-Industry collaborative, INDUNIV about



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possible collaboration for the future. Aspects of collaboration include the use, by
INDUNIV, of the Biopharmaceutical Manufacturing Industry Skill Standards by
educators in Puerto Rico and collaboration around the design and use of academic Pilot
Plants (another collaborator around academic Pilot Plants is Sengyong Lee from Ivy Tech
Community College in Bloomington Indiana). In fact, one of the outcomes of the
academic Pilot Plant collaboration may be the formation of a small sub-group of
community colleges and universities with academic Pilot Plants, perhaps out of the
Interenational Society of Pharmaceutical Engineers (ISPE).
        NBC2 Advisory Board Meeting at MCCC in Blue Bell, PA, October 5-6, 2006
        This meeting had a great turn-out of biomanufacturing companies and educators
from community colleges and a technical high school. Some high lights were the
demonstration of a new part of the www.biomanufacturing.org website for the Global
Biomanufacturing Curriculum (GBC). The GBC will be a repository of curriculum,
instructional materials and resources to support biomanufacturing education and training
throughout the Northeast, nation and globe. Materials will be produced at each of the
Hubs in the Northeast and placed on the GBC for use by others. Materials will also be
garnered from around the nation and globe. Member educators and biomanufacturing
company partners will be able to access these materials for no charge.

         NSF ATE PI Meeting in Washington, D.C., October 18-20, 2006
         This was our first NSF ATE PI meeting where we exhibited as a Center (some of
us went to the October 2005 meeting, but we did not exhibit as we had just received the
grant September 1, 2005). We purchased a display banner that advertises our Center and
its activities (the funds came from our NH BET Center account and not from NBC2
funds). We also displayed booklets containing annual reports from each Hub (we were
just over one year as a Center), booklets containing SOPs developed for hands-on
training for the ten jobs targeted by the grant, the publication of one of our Core
Production Systems, the CHO-tPA Core Production System by Sonia Wallman and Deb
Audino, a video of the Minuteman Regional Technical High School
biotech/biomanufacturing facilities, education and training, and a demonstration of the
Global Biomanufacturing Curriculum containing SOPs for targeted jobs, along with job
related skill standards, and resources to support biomanufacturing education and training.
Our booth was across from the Bio-Link booth and we hope that will be the case next
year as well.

        Indiana BioFutures Meeting at Eli Lilly’s QMLC in Indianapolis and Ivy Tech
Community College in Bloomington, IN, November 13-15, 2006 (funded by Indiana
BioFutures)
        For three years, a number of biomanufacturing educators in the nation have been
working with Indiana biomanufacturing companies and the new Ivy Tech Community
Colleges to help them with the development of biotech/biomanufacturing programs at six
Ivy Tech campuses. This year we visited Ivy Tech Community College at Bloomington,
Indiana. The visit was to help the Ivy Tech Community Colleges with the development
of internships and apprenticeships to support their biotech/biomanufacturing programs.
There was much company participation during these meetings. One big Action Item that
we came away with was that the PI of the NBC2 would ask for a NSF supplement to



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convene a meeting in Indianapolis to “harmonize” the various biomanufacturing skill
standards used throughout the nation for curriculum and instructional materials
development.
        As part of the BioFutures meeting in Indiana, we toured the Eli Lilly Quality
Management Learning Center (QMLC) in Indianapolis. This is an old Eli Lilly Pilot
Plant that has been gutted, refurbished and turned into a training center for incumbent
workers and new hires.

        AACC-FAS Ireland Collaboration Meetings in Cork, IE, January 30-February 3,
2007 (funded by FAS, Ireland)
        Several biopharmaceutical companies are currently located in Ireland. They
include Wyeth, Amgen, Centocor, Schering Plough, Elan and Eli Lilly. The PI of the
NBC2 was invited on behalf of the AACC and FAS Ireland to a meeting in Cork, Ireland
for the purpose of talking about biomanufacturing education, training, the workforce and
apprenticeships. We also toured a 45,000 square foot training facility that is under
construction near Cork where most of the biomanufacturers are located.
        The most important Action Item to come out of this meeting was to add Ireland to
the meeting in Indiana. The PI of the NBC2 will request an NSF supplement to convene a
meeting in Indiana on September 24, 25 and 26, 2007 for the purpose of
national/international harmonization of the biomanufacturing skill standards. We will
focus on six of the ten targeted jobs (the ones that employ the most people): upstream and
downstream processing; quality control biochemistry and microbiology; validation and
process development.

Website
        The website for the NBC2 at www.biomanufacturing.org is constantly being
updated and changed. We have now exchanged links, creating an Internet relationship,
with the National Biotechnology Center, Bio-Link at www.bio-link.org and the
Manufacturing Education Resource Center, MERC at www.merc.net.
        During this year, the expansion of biomanufacturing companies accelerated
greatly in the Northeast, even beyond the expansion that we documented in our grant
application to NSF in 2004 to become a Biomanufacturing Center. Because of this we
created a new section of the website “Northeast Biomanufacturing Jobs” to
             1. chronicle biomanufacturing company expansion in press articles,
             2. advertise current jobs at Northeast biomanufacturing companies,
             3. offer links to Northeast biomanufacturing company job boards.
We have also added a “ticker tape” at the bottom of the HomePage of
www.biomanufacturing.org to highlight expansion of biomanufacturing companies in the
Northeast. Links to articles relative to “ticker tape” content can be found under press
articles. In order to compliment the “Northeast Biomanufacturing Jobs” section of the
website, we built a new section of the website “Northeast Biomanufacturing Education”.
To develop this section of the website, the NBC2 is contacting biotechnology
programs at community colleges and technical high schools throughout the twelve states
of the Northeast region to get contact information, descriptions of their
biotech/biomanufacturing programs, and logos. Eighteen programs from the six New
England states can be found at www.biomanufacturing.org/edpartners.php. We are



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awaiting program information from the remaining six Northeastern states and will post
that information when we have it.
        We have also added a section on the Department of Labor registered
Biomanufacturing Apprenticeship program. Two of the ten targeted jobs have already
been registered with the DOL, upstream and downstream processing biomanufacturing
technician. We are working with the Department of Labor to register the Quality Control
technician jobs and in time we’ll add Validation and Process Development technician
jobs, and later Quality Assurance, Metrology, Facilities and Environmental Health and
Safety jobs. The section of the website on Biomanufacturing Apprenticeships also
contains information as to how to develop one’s own Biomanufacturing Apprenticeship
program.
        Finally, we are working on another section of the website which can be found at
www.biomanufacturing.org/gbc. This is the Global Biomanufacturing Curriculum
(GBC) section of the website. It is not currently linked to the NBC2 website at
www.biomanufacturing.org. The GBC is the beginning of a repository of curriculum,
instructional materials and resources for biomanufacturing education and training for
access by existing and newly developing biomanufacturing programs throughout the
Northeast, nation and globe. The Northeast will be developing a good amount of the
materials found on the GBC, however we will rely on our many biomanufacturing
partners throughout the nation and globe to add materials. Shortly, we will be receiving a
Gowning SOP from Rosa Buxeda at the University of Puerto Rico-Mayaguez. We will
be adding the Gowning SOP to the Quality Assurance section of the GBC. One of the
reasons that we have not gone public with this portion of the website is because we are
formalizing membership documents for educators, educator-industry partners and
vendors. Once these documents are constructed (we are using Joanna Kile’s CAPT
Center membership documents), membership will be required to access the GBC.
Membership is free to educators and educator-industry partners; vendors will be charged
a membership fee. We should have the GBC up and running by the beginning of this
Summer and surely by BIOMAN 2007. We will be formally unveiling the site at
BIOMAN 2007.
        Website traffic continues to grow. We will continue to rearrange, tighten up and
improve the website and would appreciate ideas that would encourage the use of the
website.

NBC2 Objective #5: Build biomanufacturing infrastructure capacity and self-
sufficiency
        At the NBC2 Exhibit at the NSF ATE PI Meeting at the Omni Shoreham in
Washington, DC, some of our ideas for self-sufficiency were on view. One is to sell
publications (books, CDs, DVDs, etc.) that we’ll link to the Global Biomanufacturing
Curriculum. Another is to charge Vendors for NBC2 Membership (NBC2 Membership
for Educators and Educator/Biomanufacturer Partnerships, on the otherhand, would be
free). Another idea is to utilize some of the income from the NH Pilot Plant (part of the
Facilities curriculum deliverable by the Northern New England Hub) to support the
NBC2. Another is for us to each utilize a branch of the Northeast Biomanufacturing
Institute (NBI) to train the local incumbent workforce. NHCTC developed the NBI in
2004 as part of the US DOL ETA grant that funded the National Center for the



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Biotechnology Workforce. On March 26, 27, and 28, 2007 one of the courses to be
offered as part of the NBI at NHCTC is a Biomanufacturing Seminar taught by Tom
Burkett, Hub Director at CCBC in Catonsville, MD and Deb Audino, Biomanufacturing
Faculty for the Northern New England Hub at NHCTC. Hopefully, other Hubs will offer
NBI courses to incumbent workers in their locale. In time each Hub’s incumbent worker
training programs through the NBI could serve as one aspect of self-sufficiency.




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