Leveraging Federal Funding...The TAA CCCBC

1. The Biomanufacturing Hub of the CCCBC
CCP BIO 2013 - April 22, 2013
Sonia Wallman,
NBC 2 PI and Executive Director
CCCBC Biomanufacturing Hub Co-PI

2. NBC2 History
 In 1998 the Co-PI joined Bio-Link as the Northeast
hub, already specializing in biomanufacturing
 In 2005 the Co-PI received a center grant for
biomanufacturing, the Northeast Biomanufacturing
Center and Collaborative. This fall we received Phase
III funding for the NBC2 which included funds for
developing a national certification in
biomanufacturing.
 Shortly after the announcement of the NSF ATE
NBC2 grant, we learned we were the
Biomanufacturing Lead for the DOL TAA CCCT CCCBC.

3. NBC2 Phase III
National Regional Hubs
New England Hub
Mount Wachusetts Community College Devens, MA
Upstate New York Hub
Finger Lakes Community College, Canandaigua, NY
BigPharma Hub
Montgomery County Community College, Blue Bell, PA
Bucks County Community College, Newtown PA
Mid-Western Hub
Ivy Tech Community College, Bloomington, IN
Western Hub
MiraCosta College, Oceanside, CA
Southern Hub
Alamance CC, Graham, NC

4. Biomanufacturing in the US

5. NBC2 History
 Biomanufacturing Skill Standards Harmonization Meeting at
Ivy Tech CC, Indianapolis, Indiana in September 2007
 Strategic Planning Meeting at MiraCosta College in
Oceanside, CA in 2008 developed the NBC2 mission and vision
 Strategic Planning Meeting at the Community College of
Baltimore County in Baltimore County, in Catonsville, MD in
2010 voted to pursue biomanufacturing certification.
MISSION
To coordinate local and regional
efforts into a national
biomanufacturing education and
training system to promote, create,
and sustain a qualified workforce.
VISION
To be the nationally recognized
center of excellence that develops a
world-class sustainable
biomanufacturing workforce to
improve the quality of life.
.

6. Biomanufacturing Skill Standards Development
Supporting the Growth of the Bioeconomy
 Meeting of SMEs planned for June 28th
at MCCC in Blue Bell, PA
funded by NBC2 Phase III
 SMEs from industry will develop a set of skills reflecting the
entire span of biomanufacturing including biopharmaceutical
and industrial biotechnology manufacturing
 The resulting skills list will be sent to large group of technicians
working in biomanufacturing to validate.

7. Subject Matter Expert List
 Lisa Stillwell; lisa.stillwell@lifetech.com; Manager, Product Development; CA
 Deborah Grant; deborah.grant@abbott.com: Training Team; MA
 Eric Gennell; eric.gennell@genzyme.com: Quality Assurance; MA
 Sean Kiet Tieu; sean_tieu@hgsi.com; Downstream Processing; MD
 Nigel C. DePeiza; nigel_dePeiza@hgsi.com; Manufacturing Operations; MD
 Jon Conary; john.conary@hgsi.com; Director of Manufacturing: MD
 Bryan Shingle; bshingle@its.jnj.com; Clinical Manufacturing; PA
 Gleb Epelbaum; gepelbau@its.jnj.com; Sr. Biotechnician; PA
 Jason Condon; jcondon1@its.jnj.com; Scientist; PA
 Jim Kulp; jkulp3@its.jnj.com; Director of Manufacturing; PA
 Robert (Bo) Henry; Robert.Henry@cookpharmica.com; IN
 Mark Kruszynski; mark_kruszynski@baxter.com; Baxter Biopharm Solutions; IN
 Daniela Olszova; daniela.olszova@gilead.com; QC Assay Development; CA
 Ben Locwin; ben.locwin@lonza.com; Quality Assurance; NH
 Pat Sacco; psacco@shire.com; Sr. Vice President Manufacturing & Internal Operations; MA
 Paul Kennedy, pxkpaul@gmail.com; Regulatory Affairs and Quality Engineer; PA
 Mandi Waringa, www.danisco.com; QA and Food Safety Manager; NY
 Karen Arreola, karenarreola@msn.com, Manufacturing Operations, Amgen); CA
 Teresa Moore, TSSB; TX

8. Leveraging NBC2 to Develop a Core
Bioscience Skill Standard
 NBC2 will leverage its resources, to develop a
biomanufacturing skill standard that can be used
together with the lab skill and biomedical device
skill standards developed by Bio-Link and
Sengyong Lee’s group to produce a CCCBC Core
Bioscience Skill Standard.

9. Building Local Biomanufcturing
Career Pathways
 MCCC and Bucks will develop sustainable, local biomanufacturing career
paths to support the development and growth of biomanufacturers
making bioproducts such as biopharmaceuticals, and also biofuels and
biomaterials to replace petroleum based manufacturing.
 These career pathways will start at the local WIBs (including the
Philadelphia area WIB), the local high schools, the workforce
department and academic support areas of the colleges, and involve the
local biomanufacturers.

10. Building Local Biomanufcturing
Career Pathways
 Our other Biomanufacturing Hub partner in the
CCCBC is LA Valley College in LA/Orange County
region (and informally LA Trade Tech in
downtown LA). You will hear from Lennie Ciufo,
Workforce Director, this afternoon. Under
Lennie’s leadership, a wonderful partnership with
Baxter has been developed and they are working
on an incredibly interesting set of stacked
credentials that are being fashioned into an A.S.
degree in Biotechnology.

11. Biomanufacturing Course Development
 With our CCCBC Biomanufacturing Hub partners we will build
biomanufacturing suites housing biomanufacturing
equipment, collaboratively write new equiment and process
SOPs and a hands-on lab manual for a new biomanufacturing
course that will be embedded in biotechnology programs at
LA Valley, Bucks and MCCC.
 Again, leveraging NBC2 expertise, the hands-on laboratory
course will be accompanied by 15 two-hour interactive online
learning experiences each with a set of slides furnished by
NBC2 PI and Co-PIs and based on the NBC2 industry written
Introduction to Biomanufacturing textbook.

12. Virtual Industrial Biomanufacturing
 Continuing to work with Yakov Cherner and
ATe-Learning to develop an Virtual Industrial
Upstream Processing module funded by NBC2.
 Will begin on Virtual Downstream Processing
module funded by CCCBC.
 This will be integrated into the
Biomanufacturing course we are constructing
to be used by our Biomanufacturing Hub
partners and others.

13. Virtual Industrial Biomanufacturing

14. Virtual Industrial Biomanufacturing