Sentry BioPharma ServicesMay 13, 2015 · Sentry BioPharma Services • Contract Service Provider...
Transcript of Sentry BioPharma ServicesMay 13, 2015 · Sentry BioPharma Services • Contract Service Provider...
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Sentry BioPharma Services
• About Us
• Our Facility
• Our Capabilities
• Our Experience
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ABOUT US
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Sentry BioPharma Services
• Contract Service Provider
• Privately held company
• Extensive Industry Experience
• Exclusively serves lifescience industry
• Commitment to grow with the needs of our Clients
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What Makes the Difference
Location
• Central Location with Global Reach
• Adjacent to IND Airport
and FedEx hub • Interstate Access
• 75% U.S. within 1 day
truck drive
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What Makes the Difference
Security
• Human Resources • Access Restriction • Monitoring
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What Makes the Difference
Transparency
• Collaborative Teams • Web Access • Automated
Notifications
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What Makes the Difference
Quality
• 21 CFR, Part 210 & 211 Compliant • FDA Labeler Code • Robust Regulatory History
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Regulatory Inspections Agency Scope Date
Federal Aviation Administration (FAA), Security and Hazardous Materials Routine Compliance Inspection 12/29/2014
United States Department of Agriculture (USDA) Client-specific 10/28/2014
Pharmaceuticals and Medical Devices Agency, (PMDA), Japan Registration Renewal 07/28/2014
US Customs and Border Patrol (CBP) General 06/20/2014
National Association of Boards of Pharmacy® (NABP®) Triennial Reaccreditation Site Survey 06/11/2014
Food and Drug Administration (FDA) Routine Surveillance Inspection 02/03/2014
Drug Enforcement Administration (DEA) Routine Compliance Inspection 11/21/2013
Food and Drug Administration (FDA) Client-specific 03/19/2013
United States Department of Agriculture (USDA) Client-specific 08/14/2012
Medicines and Healthcare products Regulatory Agency (MHRA) Client-specific 03/13/2012
Drug Enforcement Administration (DEA) Import License 12/19/2011
Food and Drug Administration (FDA) Routine Surveillance Inspection 12/05/2011
Pharmaceuticals and Medical Devices Agency, (PMDA), Japan Client-specific 10/2011
National Association of Boards of Pharmacy® (NABP®) Triennial Reaccreditation Site Survey 02/17/2011
Drug Enforcement Administration (DEA) Routine Compliance Inspection 12/01/2010
Pharmaceuticals and Medical Devices Agency, (PMDA), Japan Client-specific 08/16/2010
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OUR FACILITY
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Our Property
2nd Largest FedEx Air Hub
“IND” International Airport FedEx
Freight
Sentry BPS
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Our Building
Sentry BioPharma Services, Inc.
Decatur Blvd.
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Facility Layout
• State-of-the-art Facility
• 53,000 square feet • Built to Factory Mutual
(FM) Specifications • Validated Systems &
Environments
• Rapid Expansion Capabilities
Ambient Warehouse
(15°C to 30°C)
Refrigerator (2°C to 8°C)
Freezer (-15°C to -25°C)
Ambient Warehouse
(15°C to 30°C)
Freezer (-33°C to -43°C)
Freezers (-70°C to –90°C)
Freezers (-70°C to –90°C)
DEA CAGE 02
DEA CAGE 03
DEA CAGE 04
DEA CAGE
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OUR CAPABILITIES
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Capability Overview
• Storage Solutions
• Manufacturing Support
• Supply Chain Management
• Commercial Services
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Storage Solutions • cGMP Storage
• Ambient +15°C to +30°C
• Refrigerated +2°C to +8°C
• Frozen -15°C to -25°C • Low Temp Frozen -33°C to -43°C • Ultra-Low -70°C to -90°C
• Custom Temperature Solutions
0°C to -90°C
• Controlled Substance (III – V)
• FTZ available across all storage conditions
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• Seasonal/Pandemic Solutions Vaccine and bio-defense product storage and rotation combined with executable plans for epidemic or pandemic surge distribution support
• Government contract awards: • 2013: 12/17/2012: CDC contract - influenza vaccine storage and distribution • 2012: 01/13/2012: CDC contract - influenza vaccine storage and distribution
• 2011: 8/04/2010: HHS contract – H1N1 product management and destruction
• 2010: 2/23/2010: CDC contract - influenza vaccine storage and distribution
• GSA Logworld Supply Schedule Contract Award
Capabilities
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Manufacturing Support
• Labeling
• Packaging
• Kitting
• Depot Services
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Manufacturing Support
Labeling
• Clinical and Small-Scale Commercial
• Temperature Sensitive Products • Open and Blinded • Multilingual
• Peel-off / Perforated
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Manufacturing Support
Packaging
• Bulk packaging • Single- / Multi-dose cartons • Package Inserts • Kits
• Double-blind Packaging • Tamper-evident
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Supply Chain Management
• Cold Chain Management
• Domestic and Global Distribution
• Cross-docking
• Channel Qualification
• Import Optimization
• Foreign Trade Zone (FTZ)
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Commercial Services
• Order Fulfillment
• Returns Management Program
• Trade and Sample Management
• VAWD® Accredited
• Licensed in all 50 states and U.S. Territories
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Capability Review
• Storage Solutions
• Manufacturing Support
• Supply Chain Management
• Commercial Services
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Our Experience
• Diverse Client Projects
• Experienced Personnel
• Custom Solutions
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Our Commitment
• Protect Product Integrity
• Transparency to ensure quality customer service and quality solutions
• Expand capabilities and services along with the needs of our clients
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