Southern Indiana Life Sciences Training Institute Sengyong Lee Ph.D. Associate Professor/Program...

Southern Indiana Life Sciences Training Institute

Sengyong Lee Ph.D.Associate Professor/Program ChairIvy Tech Community CollegeBloomington, 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

Medical Device Manufacturing

BioConvergenceTM

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 2003Skills 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 development1,500 new jobs in next five years – by BLSPBut limited training resources

A new Life Sciences Training Institute 25,000 ft2, three classrooms, four labs, a training suite & officesExpected to be completed in 2008

Funding Sources$5 million from the local County GovernmentITCC 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 TopicsBMTC, Aseptic Processing, Gowning, Metrology, Documentation, Environment Monitoring, Equipment operation, etc

Biomanufacturing Process Simulation (Pilot Plant) Contract manufacturing serviceTraining & 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

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

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.