Commercial Rodent Production Simonsen Laboratories. Bryan E. Blazek Wednesday November 2, 2016
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2 Commercial Rodent Production Simonsen Laboratories Bryan E. Blazek Wednesday November 2, 2016
3 Today s Objectives Review Concepts Introduce Concepts Integrate Concepts
4 Target Market Pharmaceutical and Biotechnology Research Safety /Efficacy Testing (Regulatory - FDA) Universities Research Contract Laboratories Research Safety /Efficacy Testing (Regulatory - FDA) (Zoos & Wildlife Organizations)
5 Product Mice, Rats, and Hamsters Inbred (20 consecutive B x S matings) Hybrid (CB6F1 Balb/c X C57Bl/6 ) Outbred (Heterozygosity) Transgenic (Engineered) Mutant (Spontaneous)
6 Product Components Product Quality Service Health Status Genetic Integrity Delivery Availability Special Products & Services
7 Product Quality Health Status Primary Interest (Required of Vendors)» Conventional» SPF (Specific Pathogen Free)» Virus Antibody Titer Free» Restricted Flora (Free of Opportunistic Organisms)» Defined Flora (Gnotobiotic)» Germ Free (Axenic)
8 Product Quality Genetic Integrity Avoid Line Formation»Restarts Avoid Inbreeding Of Outbred Stock» Random Mating Schemes Assure Traceability» Pedigree Records
9 Production Basic Principles of Animal Production Maximize Reproduction (# of Weaned Offspring)» Little Genetic Diversity In Inbred Strains» Inbreds Must Be Mated Brother X Sister Record Keeping to Measure Performance» Colony Level» Individual Performance Difficult To Measure» Production Efficiency Index = #Weaned/Dams» Cage Level Observations
10 Colony Management Inbred Strains FOUNDATION Foundation EXPANSION Expansion Production PRODUCTION
11 Foundation Colonies Pedigreed Brother X Sister Mating Mating Scheme: 1 X 1 (Pair) Extensive Recordkeeping Genetic Testing Limit Generations From The Original Pair Provides Replacement Breeders and Supplies Expansion Breeders (Gnotobiotic -- Small Isolators)
12 Colony Management Inbred Strains FOUNDATION Foundation EXPANSION Expansion
13 Expansion Colonies Breeders From Foundation Colony Pedigreed Brother Sister Mating Mating Scheme: 1 Male X 2 Females Supplies Production Breeders (Housed In Room Sized Isolators)
14 Colony Management Inbred Strains FOUNDATION Foundation EXPANSION Expansion Production PRODUCTION
15 Production Colonies Breeders From Expansion Colony Limited To One Generation Of Non B x S Mating Scheme Determined By Performance Produces Offspring For Sale (Room Size Isolators)
16 Colony Management Outbred Strains Large Foundation Colony (Gnotobiotic) Systematic Outbreeding Foundation Supplies Production Colony
17 Facilities And Equipment Physical Plant Buildings And Systems Housing Systems Small Glove Box Flexible Film Isolators Room Size Flexible Film Isolators Barrier Housing (phasing out for rodent production)
18 Physical Plant Buildings Three Barriers Gnotobiology Building Feed Mill Maintenance Shipping & Receiving Administration Diagnostic Laboratory
19 Physical Plant Equipment Boilers Primary And Secondary Autoclaves Heating Animal Rooms Pellet Mill
20 Physical Plant Equipment Water Chillers Cooling Animal Rooms 2X Capacity (total of 8)
21 Physical Plant Equipment Power Supply Primary And Secondary Utility Supplied Diesel Backup» Switches On Automatically» Supplies Power For Entire Facility» Capacity For 48 Hours Of Continuous Service
22 Housing Systems Most Restrictive Glove Box Isolators Room Size Isolators (Barriers) Least Restrictive
23 Small Flexible Film Isolators Absolute Supply And Exhaust Filters Supplies Through An 18 Inch Diameter Port
24 Small Flexible Film Isolators Loaded supply cylinder sealed with mylar. Cylinders autoclaved Connect with a vinyl sleeve. Sprayed with chlorine dioxide
25 Small Flexible Film Isolators Autoclaved water in bottles 33 Mouse / 14 Rat Manipulations Through Attached Gloves
26 Room Size Flexible Film Isolator Absolute Supply Filter Filtered Exhaust Positive Pressure
27 Room Size Flexible Film Isolator Supplies Through A 24 Inch Diameter Port
28 Room Size Flexible Film Isolator Chlorinated Water Filtered To 0.22 Microns Automated Watering
29 Room Size Flexible Film Isolator Capacity 1600 Mouse 864 Rat
30 Room Size Flexible Film Isolator Sterile Entry By Caretakers Sealed In Self Contained Suits
31 Room Size Flexible Film Isolator Manipulations By Caretakers Sealed In Self Contained Suits
32 Barrier HEPA Filtered Fresh Air Redundant Air Handlers Equipment On A Roof Within The Attic
33 Barrier Supplies Autoclaved 20 Rooms Mouse Dams / 800 Rat Dams Per Room Manipulations By Caretakers In Scrubs
34 Housing and Husbandry New Starts NIH Or Other Source Caesarian Derivation
35 Housing and Husbandry Pups Fostered to Gnotobiotic Dam Establish Foundation Establish Expansion Establish Production Sell Offspring
36 Quality Quality Control Health Monitoring Genetic Testing Quality Assurance Standardization Of Procedures Process Validation Complaint Processing
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Animal Care and Use Application June 2018 Application Instructions Complete all sections in the attached application. If the question does not apply to your study enter N/A. Applications, can be submitted