Biologics Modular designs and manufactures modular facilities for biomanufacturing. Their DeployReady Platform uses pre-engineered modular designs that allow for cost-effective and flexible manufacturing facilities. The modular designs can be transported globally and assembled on site, providing a standardized approach to setting up biomanufacturing operations anywhere in the world.

2. Headquartered in Brownsburg, IN, Biologics Modular, LLC,
designs and manufactures modular facilities to serve as
biomanufacturing and research suites to health science service
providers, educational facilities and pharmaceutical
manufacturers.

3. Outline
Introduction
Global Deployment Strategy
Final Site Assembly
Modular Design Process
Pre-Engineered Designs
• Aseptic Filling Facility (503B)
• USP 797 and 800 Compounding Pharmacy
• Integrated Facilities
• DeployReady Biomanufacturing Suite
• Upstream Processing Suite
Project Examples
• Aseptic Filling Facility (503B)
• Cell Therapy Facility
Summary
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3

4. The Biologics Modular DeployReady Platform (DRP) is based
upon current CGMP manufacturing processes of the FDA
regulated industries.
Introduction
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DRP design encompasses the following attributes:
1. Cost-effective, pre-engineered facility structure.
2. DRP coupling system allows for manufacturing process
flexibility.
3. Integrated utility, control and monitoring systems.
4. Replicated, staged, multi-site manufacturing deployment
strategy enhances pre-approval inspection process.
5. Transportable facilities for global deployment strategies.
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5. Global Deployment Strategy
DeployReady Global Strategy
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6. Final Site Assembly
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Final Assembly
•Five Container
•Inside Core Build
Warehouse
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7. Modular Design Process
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8. Modular Design Process
Computational Fluid Dynamics
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Simulates the facility design to minimize errors
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9. Modular Design Process
Intermodal Container Platform
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Intermodal container platform retains transportation
corner blocks, a system that is used all over the world
for shipping.
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10. Modular Design Process
Intermodal Container Platform
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In a few weeks, the container is completely
transformed into a factory acceptance tested, clean
facility that can go any where in the world.
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11. Pre-Engineered
Designs
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12. Aseptic Filling Facility (503B)
Aseptic Regular Finish Fill (VanRx SA25)
Self-Contained Aseptic Filling
Facility
• Gloveless filling isolator
• Fills vials, syringes and cartridges
• Integrated sterilization system
• Modular platform
Pre-Engineered Designs
www.BiologicsModular.com
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13. Aseptic Filling Facility (503B)
Aseptic with Lyophilization (VanRx SA25)
Pre-Engineered Designs
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Self-Contained Aseptic Filling Facility
• Raised ceiling to accommodate finish
fill equipment
• Fully constructed offsite and then
delivered post FAT
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14. USP 797 and 800 Compounding Pharmacy
Compounding Pharmacy
• Integrated air handling and utilities
• Meets USP 797 or 800 standards
• Off the shelf design; 22 feet of casework and storage,
fume hood, refrigerator or freezer, gas systems and
safety shower
Pre-Engineered Designs
www.BiologicsModular.com
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15. Cell Therapy Facilities
Pre-Engineered Designs
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16. DeployReady Biomanufacturing Suite
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17. Upstream Processing Suite Visualization
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18. Project
Examples
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19. Aseptic Filling Facility
Project Examples
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19
Self-Contained Aseptic
Filling Facility
• Raised ceiling to
accommodate finish fill
equipment.
• Fully constructed offsite,
factory acceptance tested
and then delivered to the
clients facility.
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Rights Reserved, Confidential

20. Cell Therapy Facility
Project Examples
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20
Self-Contained Cell
Therapy Facility
• Simple 2 container layout
• Can be quickly
disassembled for
relocation.
• Fully constructed offsite
and then delivered post
FAT
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21. Partners
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22. Summary
Our template processes and modular
manufacturing platforms are:
• A faster and more cost effective path to
GMP manufacture.
• Scalable.
• Transportable.
• Developed by experienced design and
engineering teams at Biologics Modular
and our partners.
www.BiologicsModular.com
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