The Biomanufacturing Hub of the CCCBC CCP BIO 2013 - April 22, 2013

Sonia Wallman,NBC 2 PI and Executive DirectorCCCBC Biomanufacturing Hub Co-PI

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.

NBC2 Phase IIINational Regional Hubs

New England HubMount Wachusetts Community College Devens, MA

Upstate New York HubFinger Lakes Community College, Canandaigua, NY

BigPharma HubMontgomery County Community College, Blue Bell, PA

Bucks County Community College, Newtown PAMid-Western Hub

Ivy Tech Community College, Bloomington, INWestern Hub

MiraCosta College, Oceanside, CASouthern Hub

Alamance CC, Graham, NC

Biomanufacturing in the US

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.

MISSIONTo coordinate local and regional efforts into a national biomanufacturing education and training system to promote, create, and sustain a qualified workforce.

VISIONTo be the nationally recognized center of excellence that develops a world-class sustainable biomanufacturing workforce to improve the quality of life.

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Biomanufacturing Skill Standards DevelopmentSupporting 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.

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

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.

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.

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.

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.

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.

Virtual Industrial Biomanufacturing

Virtual Industrial Biomanufacturing