Manufacturing More Than Pharmaceuticals-The Chao Center

Manufacturing Facility

Dr. Allen and Lee-Hwa Chao

From a Shell

To A Clean Corridor

Non cGMP Pilot Lab

Analytical /Formulation Laboratory

Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing

Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives

Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives Education — Attain and preserve excellence in learning through programs of superior quality and value in Pharmaceutical Development and cGMP Manufacturing Training

Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives Education — Attain and preserve excellence in learning through programs of superior quality and value in Pharmaceutical Development and cGMP Manufacturing Training Summer Internships (2) The Chao Center Internship Johnson & Johnson Internship Graduate Fellowships (1) Clerkships (2) High School Work Study (1) Manufacturing — cGMP Manufacturing of both clinical and commercial product

Mission & Goals Mission — Preeminence in Pharmaceutical Education, Development, and Manufacturing Goals and Objectives Education — Attain and preserve excellence in learning through programs of superior quality and value in Pharmaceutical Development and cGMP Manufacturing Training Summer Internships (2) The Chao Center Internship Johnson & Johnson Internship Graduate Fellowships (1) Clerkships (2) High School Work Study (1)

Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product

Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product Formulation and Analytical Development — Effectively address the needs of healthcare and the pharmaceutical industry

Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product Formulation and Analytical Development — Effectively address the needs of healthcare and the pharmaceutical industry Faculty and Research Use — Mutually Beneficial Access to a cGMP Facility

Mission & Goals Manufacturing — cGMP Manufacturing of both clinical and commercial product Formulation and Analytical Development — Effectively address the needs of healthcare and the pharmaceutical industry Faculty and Research Use — Mutually Beneficial Access to a cGMP Facility Create a Positive Impact on the Local and State Economy

-itis (Innovation) Facility Created a Portable Degowning Room Purchased an Off the Shelf Portable Clean Room (positive pressure) Added Casters for Portability Turned the HEPA Filters Upside Down (negative pressure) Qualified the System Developed a Cross Contamination Filter Identified Need Designed Device to Adapt to Differential Pressure Sensor and Sterile Filter Design Filter Removal and Addition Pole Applied for Provisional Patent

-itis (Innovation) Designed Drop Down Conduit for Laboratory Determined Design Limits Electrical Cords off Lab Bench-Safety and Space Limits Initial Cost and Allows Expansion of Services Allows Conduit to be Adapted for: Additional Snorkels to Remove Gases Additional Electrical Outlets with Different Voltages Additional Computer Outlets

cGMP Documentation Over 150 Standard Operating Procedures

cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs)

cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files

cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages

cGMP Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages 17 Operation Qualification (OQ) Packages

Center Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages 17 Operation Qualification (OQ) Packages 3 Performance Qualification (PQ) Packages

Center Documentation 150 Standard Operating Procedures 15 Enhanced Turn Over Packages (ETOPs) 64 Equipment History Files 17 Installation Qualification (IQ) Packages 17 Operation Qualification (OQ) Packages 3 Performance Qualification (PQ) Packages Over 60 designated logbooks

cGMP Documentation Over 17,000 pages of Documentation

cGMP Documentation Over 17,000 pages of Documentation Placed end-to-end, documentation would cover the distance from The Chao Center to the School of Pharmacy and most of the way back

Lilly Contract Signing at the Dedication for Seromycin

Pharmaceutical Development Pre-Formulation Formulation Development and Pilot Lab Analytical Methods and Validation Studies Test of Raw Materials for Manufacturing Test Finished Product Develop and Validate Analytical Methods Stability Testing and ICH Stability Storage Stability Software Stability Chambers Regulatory Services

Manufacturing Tablets

Manufacturing Tablets Capsules

Manufacturing Tablets Capsules Semi-solids

Manufacturing Tablets Capsules Semi-solids Syrups

Manufacturing Tablets Capsules Semi-solids Syrups Suspensions

Manufacturing Tablets Capsules Semi-solids Syrups Suspensions Over-encapsulation (Blinding Studies)

Manufacturing and Analytical Equipment Zanasi Encapsulator Tooling Manesty Betapress (B-Tooling and D-Tooling) Kalish Bottle Capper Kalish Bottle Washer Tote Blender Gruenberg Oven Loma Metal Detector Sade-P2 Weigher / Sorter

Manufacturing and Analytical Equipment Enercon Induction Sealer Key Tablet Deduster / Capsule Polisher Agilent UV/Vis Spectrophotometer Agilent 1100 HPLC’s (2) Varian Dissolution Bath Agilent GC/Mass Spectrophotometer Compulab Tablet Coater Fluid-Air Fluid-Bed Dryer

Hands Across the Campus School of Pharmacy/Chao Center Integrating Education between Pharmacy and The Chao Center Support School of Pharmacy Functions Krannert-ECE Project Improve material receiving/handling processes Investigate automating warehouse temperature and humidity mapping procedure Birck Nanotechnology cGMP Initiative

Hands Across the Campus Civil Engineering 489 Course Project Students to design rotary oxidizer kiln and associated support facilities that theoretically will be located at The Chao Center

Partnerships/Relationships Pharmaceutical Companies Eli Lilly and Company Abbott Laboratories Johnson & Johnson Large, Medium and Small Pharma International Relationships AION-Australia Hisun Pharmaceuticals-China Kazakhstan-Ministry of Health Mahidol University-Bangkok, Thailand

Pharmaceutical Expertise 5 out of 17 Employees with over 80 years of Combined Pharmaceutical Industry Experience Experience in Writing CMC Sections for NDA’s, IND’s, ANDA’s and NADA’s Regulatory Knowledge Regarding Inspections, Submissions and Facilities Development and Manufacturing Experience in Nasals, Tablets, Capsules, Suspensions, Semi- solids, Lyophilization, and Injectables Integral Part of Development of Zidovudine, Exosurf, Lamictal, Lotemax, and Xigris

Manufacturing More Than Pharmaceuticals Education and the Training of Students Innovation Hands Across the Campus Program Faculty Research that is Mutually Beneficial Internationally Known and Recognized Supporting University, Pharmacy and Purdue Research Foundation Initiatives Entrepreneurial Positive Impact on the State of Indiana Economy

Training Segment-Flying Insect Light Traps Clean traps and replace glue- boards in sconce light traps Corridor 123 Corridor 128 Clean trap and empty catch drawer in vertical light traps Room 133 Room 134 Replace bulbs annually, in spring