manufacturing more than pharmaceuticals-the chao center

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 ObjectivesEducation — 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 ManufacturingGoals 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 InternshipJohnson & 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)

FacilityCreated 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 FilterIdentified 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 LaboratoryDetermined 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 Procedures15 Enhanced Turn Over Packages (ETOPs)

cGMP Documentation

150 Standard Operating Procedures15 Enhanced Turn Over Packages (ETOPs)

64 Equipment History Files

cGMP Documentation

150 Standard Operating Procedures15 Enhanced Turn Over Packages (ETOPs)

64 Equipment History Files

17 Installation Qualification (IQ) Packages

cGMP Documentation

150 Standard Operating Procedures15 Enhanced Turn Over Packages (ETOPs)

64 Equipment History Files

17 Installation Qualification (IQ) Packages

17 Operation Qualification (OQ) Packages

Center Documentation

150 Standard Operating Procedures15 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 Procedures15 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 LabAnalytical 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 EncapsulatorTooling Manesty Betapress (B-Tooling and D-Tooling)Kalish Bottle CapperKalish Bottle WasherTote BlenderGruenberg OvenLoma 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 CenterIntegrating Education between Pharmacy and The Chao Center

Support School of Pharmacy Functions

Krannert-ECE ProjectImprove material receiving/handling processes

Investigate automating warehouse temperature and humidity mapping procedure

Birck Nanotechnology cGMP Initiative

Hands Across the Campus

Civil Engineering 489 Course ProjectStudents to design rotary oxidizer kiln and associated support facilities that theoretically will be located at The Chao Center

Partnerships/Relationships

Pharmaceutical CompaniesEli Lilly and CompanyAbbott LaboratoriesJohnson & JohnsonLarge, Medium and Small Pharma

International RelationshipsAION-AustraliaHisun Pharmaceuticals-ChinaKazakhstan-Ministry of HealthMahidol University-Bangkok, Thailand

Pharmaceutical Expertise

5 out of 17 Employees with over 80 years of Combined Pharmaceutical Industry ExperienceExperience in Writing CMC Sections for NDA’s, IND’s, ANDA’s and NADA’sRegulatory Knowledge Regarding Inspections, Submissions and FacilitiesDevelopment and Manufacturing Experience in Nasals, Tablets, Capsules, Suspensions, Semi-solids, Lyophilization, and InjectablesIntegral 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