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Lee
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Southern Indiana Life

Sciences Training

Institute



Sengyong Lee Ph.D.

Associate Professor/Program Chair

Ivy Tech Community College

Bloomington, IN 47404



BIO 2007

The State of Indiana and the

city of Bloomington

Biotechnology in the State of Indiana

 4.5 percent Life Sciences Job Increases rate

 300,000 direct employees in health Industry

 The second-highest concentration of

biopharmaceutical jobs in the nation and

ranking 8th in the nation in employment in

biopharmaceuticals

 Ranked 10th in the nation for projected

biopharmaceutical job increases from 2004

to 2014

 Top 10 in medical devices manufacturing in

the country

South Central Indiana and the city

of Bloomington

 Major shift from traditional manufacturing to biotech

manufacturing

 Over 5,000 employees already in

biopharmaceutical and medical device industries

 New biotechnology programs at IU and ITCC

 Strong regional partnership in promoting

opportunities in Life Sciences industry and

education

Biotech Companies in South

Central Indiana



 Contract Biomanufacturing



BioConvergenceTM







 Medical Device Manufacturing

Ivy Tech Community College

Bloomington Indiana

 Community College System in Indiana

14 Regional Campuses with about 100,000 students



 Bloomington Campus

14th regional campus

Biotechnology Program at ITCC



 Start up Grant from Lilly Endowment 2003

Skills and Knowledge Standards for Associate Degree in

Biotechnology developed by Baxter, Eli Lilly, Roche

Diagnostics, IHIF





 Six regional campuses offering the new

Biotechnology Program 2004

Bloomington, Evansville, Indianapolis, South Bend,

Terra Haute, West Lafayette

Biotechnology Program at ITCC

Bloomington



 AS and AAS Degrees in Biotechnology

AS – a degree transfer agreement with Indiana University

AAS – technical training





 Current Enrollment – 109 students

38 in AS and 71 in AAS





 Certificate Programs

Biomanufacturing & Medical Device Manufacturing

Technician Certificate, BIO-HIRE, etc

Southern Indiana Life Sciences Training

Institute Project at ITCC Bloomington



 Strong local needs for Biotech workforce development

1,500 new jobs in next five years – by BLSP

But limited training resources



 A new Life Sciences Training Institute

25,000 ft2, three classrooms, four labs, a training suite & offices

Expected to be completed in 2008



 Funding Sources

$5 million from the local County Government

ITCC Bloomington

National Science Foundation (Advance Technology Education)

Southern Indiana Life Sciences Training

Institute Project at ITCC Bloomington

Southern Indiana Life Sciences Training

Institute Project at ITCC Bloomington



 Main Training Spaces

Biomanufacturing Pilot Plant – Process Simulation

Upstream process lab

Downstream process lab

QC analytical lab



Device & Equipment Training suite

Southern Indiana Life Sciences Training

Institute Project at ITCC Bloomington

Southern Indiana Life Sciences Training

Institute Project at ITCC Bloomington



 Curriculum & Certificates on Specific Topics

BMTC, Aseptic Processing, Gowning, Metrology,

Documentation, Environment Monitoring, Equipment

operation, etc



 Biomanufacturing Process Simulation (Pilot Plant)

Contract manufacturing service

Training & education opportunities using real manufacturing

environment

Biomanufacturing Pilot Plant

 Small to mid scale biomanufacturing facility;

Upstream, downstream, filling, packaging, QA &

QC, etc



 A full time faculty, a lab assistant, and student

interns – in house internship opportunity

Biomanufacturing Pilot Plant



Biomanufacturing Pilot Plant

cGMP standard?







Advisory board’s strong recommendation;

Too much regulatory burden for an

academic program to maintain

Biomanufacturing Pilot Plant



 Biomanufacturing cGMP standard;

API manufacturing for market or clinical

trials

cGMP compliance – FDA

ISO 6 Class 1000 cleanroom,

Testing & Documentation, etc

Tight manufacturing schedule

Biomanufacturing Pilot Plant



Limited access for trainees

Biomanufacturing Pilot Plant

 cGLP Standard Biomanufacturing Pilot Plant

Manufacturing for nonclinical lab study

Contract manufacturing services for;

Process development, nonclinical studies like

agricultural, X-ray crystallography, etc



 Reduces the regulatory burden on testing & paper

work

 Allows better access to trainees

Biomanufacturing Pilot Plant



Extra Benefits;



 Service learning opportunity;

Providing DNA and protein samples to K-12

science labs



 K-12 teachers professional development workshop





 Career awareness - field trip opportunities for K-12

students

Biomanufacturing Pilot Plant



 Collecting data from companies and users



 Get hard information on the set up and optimization



 Help to replicate in other places & raise awareness

of things to think about before starting to build.


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