3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC...
-
Upload
rosaline-martin -
Category
Documents
-
view
217 -
download
0
Transcript of 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC...
![Page 1: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/1.jpg)
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
![Page 2: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/2.jpg)
Translational Critical Path for Medical Product Development
http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html
![Page 3: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/3.jpg)
Translational Critical Path Initiative
IND BLA, NDA, 510k
www.fda.gov/oc/initiatives/critical path/whitepaper.pdf
![Page 4: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/4.jpg)
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
![Page 5: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/5.jpg)
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)
![Page 6: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/6.jpg)
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)
![Page 7: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/7.jpg)
Physical Design
• Process
• Feasibility
• Scalability
![Page 8: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/8.jpg)
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
![Page 9: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/9.jpg)
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
![Page 10: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/10.jpg)
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
![Page 11: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/11.jpg)
Gowning ISO 8 Clean Room
Ms. Emily Stump; PDM Core Manufacturing Manager
![Page 12: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/12.jpg)
Gowning ISO 7 & 5 Clean Rooms
![Page 13: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/13.jpg)
CleaningDisinfectants
• Conflict• Vesephene• LpH
Fumigant • SporKlenz
RACAL Respirator Emily Stump Jessica Mierkey
![Page 14: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/14.jpg)
Environmental MonitoringRodac Plate Surface Sampler - Tryptic Soy Agar (TSA)
![Page 15: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/15.jpg)
Environmental MonitoringBiotest RCS Microbial Air Sampler
TSA StripsAPI Strips Biomerieux Inc.
Isolate IdentificationGenus:species
![Page 16: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/16.jpg)
Environmental MonitoringMetone handheld Particle Counter
![Page 17: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/17.jpg)
SterilizationISO 8 Clean Room
![Page 18: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/18.jpg)
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
![Page 19: 3 rd Dimension of Product Translation: Industrialization Becky Rivoire, B.S., RAC Director, BioMARC Department of Microbiology, Immunology & Pathology.](https://reader035.fdocuments.in/reader035/viewer/2022070408/56649e6f5503460f94b6cb98/html5/thumbnails/19.jpg)
This workforce solution was funded by a grant awarded under the Workforce Innovation in Regional Development (WIRED) as implemented by the U.S. Department of Labor’s Employment and Training Administration working in partnership with the Colorado Department of Labor and Employment, the Metro Denver Economic Development Corporation, and the City and County of Denver's Office of Economic Development. The solution was created by the grantee and does not necessarily reflect the official position of the U.S. Department of Labor. The Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. This solution is copyrighted by the institution that created it. Internal use by an organization and/or personal use by an individual for non-commercial purposes is permissible. All other uses require the prior authorization of the copyright owner.