manufacturing more than pharmaceuticals-the chao center
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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