Post on 12-Jan-2016
transcript
3rd Dimension of Product Translation: Industrialization
Becky Rivoire, B.S., RACDirector, BioMARC
Department of Microbiology, Immunology & PathologyColorado State University
Regional Training Center for Product TranslationShort-Course: Product Translation and Related Regulations
December 10, 2008
BioMARC
Translational Critical Path for Medical Product Development
http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
Translational Critical Path Initiative
IND BLA, NDA, 510k
www.fda.gov/oc/initiatives/critical path/whitepaper.pdf
Industrialization
• Physical Design• Characterization, Small Scale Production
– Preclinical lot (GLP grade material)
• Manufacturing Scale-up, Refined Specifications– Clinical lots (cGMP grade material)
• Phase I Clinical Trial• Phase II Clinical Trial• Phase III Clinical Trial
• Mass Production– Commercial lots
Bird’s Eye View
cGMPs apply to the entire production process, from raw material to final product, for any approved drug, licensed biologic, or clinical trial material.
current Good Manufacturing Practice (cGMP)
cGMP Continuum
Phase III – Approaching full cGMP: final release strategies formulated, products manufactured in facility where commercial production occurs
Commercial Production – Manufactured under full cGMP
Phase I - Manufactured under the spirit of cGMP with all procedures properly documented
Phase II - Begin to fine tune the process: develop and refine assays, perform stability studies, begin process validation for removal of impurities
(Increased compliance required at each subsequent phase)
Physical Design
• Process
• Feasibility
• Scalability
Quality Considerations
• Production
• Facilities and Equipment
• Materials
• Laboratory Control
• Product Labeling
Guidance for Industry, Quality Systems Approach to Pharmaceutical cGMP Regulations, September 2006 http://www.fda.gov/CDER/guidance/7260fnl.htm
21CFR211http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
Manufacturing Campaign
• Documentation & Risk Assessment• Gowning• Cleaning• Environmental monitoring• Materials receipt/quarantine/release• Sterilization of media/buffers• Production run• Testing for release• Product labeling• Product storage/Accountability• Quality Assurance oversight
Documentation• Specification Sheets
– Raw material– Equipment– Product
• Master Batch Production and Control Records• Standard Operating Procedures (SOPs)• Laboratory Cleaning and Use Logs• Equipment Cleaning, MainT, Calibration and Use Logs• Distribution Records• Deviation Logs• Inspection Reports• Complaint Files
PDM Core Experience
Refer to 21CFR 211, Subpart J – Records and Reports
Gowning ISO 8 Clean Room
Ms. Emily Stump; PDM Core Manufacturing Manager
Gowning ISO 7 & 5 Clean Rooms
CleaningDisinfectants
• Conflict• Vesephene• LpH
Fumigant • SporKlenz
RACAL Respirator Emily Stump Jessica Mierkey
Environmental MonitoringRodac Plate Surface Sampler - Tryptic Soy Agar (TSA)
Environmental MonitoringBiotest RCS Microbial Air Sampler
TSA StripsAPI Strips Biomerieux Inc.
Isolate IdentificationGenus:species
Environmental MonitoringMetone handheld Particle Counter
SterilizationISO 8 Clean Room
Successful Industrialization• Preclinical grade material; characterization
– GLP compliant– Animal studies– Safety and efficacy
• Clinical grade material; refine specifications– cGMP compliant– Human studies
• Phase I – safety/dose ranging• Phase II – safety/efficacy• Phase III – safety/efficacy
• Commercial grade material– cGMP compliant– Licensed facility– Licensed product
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