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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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