Biologics Modular PPT - 2016

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I. Biologics Modular designs, manufactures, and sells modular facilities for biorepositories, biomanufacturing, and research. II. Their DeployReady Platform provides pre-engineered, modular designs for facilities like aseptic filling plants and compounding pharmacies. III. The modular approach allows for a more cost-effective and scalable solution compared to traditional construction, while experienced partners help with implementation.

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

Outline
Introduction
Global Deployment Strategy
Final Site Assembly
Modular Design Process
Pre-Engineered Designs
• Aseptic Filling Facility (503B)
• Aseptic Regular Finish Fill
• Aseptic with Lyophilization
• USP 797 and 800 Compounding Pharmacy
• Integrated Facilities
• DeployReady Biomanufacturing Suite
Partners
Summary
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
3

The Biologics Modular DeployReady Platform (DRP) is based
upon current CGMP manufacturing processes of the FDA
regulated industries.
Introduction
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
4
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.

Global Deployment Strategy
DeployReady Global Strategy
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
5

Final Site Assembly
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
6
Final Assembly
•Five Container
•Inside Core Build
Warehouse

Modular Design Process
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
7

Modular Design Process
Assembly and Expansion
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
8
Deploy-Ready Coupling System (DRCS)

Modular Design Process
Computational Fluid Dynamics
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
9
Simulates the facility design to minimize errors

Modular Design Process
Intermodal Container Platform
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
10
Intermodal container platform retains transportation
corner blocks, a system that is used all over the world
for shipping.

Pre-Engineered
Designs
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com

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
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
14

Aseptic Filling Facility (503B)
Aseptic with Lyophilization (VanRx SA25)
Pre-Engineered Designs
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
15
Self-Contained Aseptic Filling Facility
• Gloveless filling isolator
• Fills vials, syringes and cartridges
• Integrated sterilization system
• Modular platform

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
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
16

Cell Therapy Facilities
Pre-Engineered Designs
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
17

DeployReady Biomanufacturing Suite
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
18
www.BiologicsModular.com

Upstream Processing Suite Visualization
19© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com

Partners
www.BiologicsModular.com
20© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential

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.
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
21

Our DeployReady Platform provides a complete production
solution to our clients.
Summary
Why use Biologics Modular?
I. Modular platform provides a more cost effective and
shortened time line, compared to a typical stick-
built facility.
II. Modular platform is scalable and if necessary
transportable.
III. Experienced design and engineering team to execute
clients’ user requirements.
IV. Strong partners to help execute necessary
implementation strategy for clients.
© 2016 Biologics Modular, LLC All
Rights Reserved, Confidential
www.BiologicsModular.com
22

Clark H Byrum, Jr.
Biologics Modular
President/CEO
(317) 456-9191 (Work)
(317) 626-4093 (Cell)
cbyrum@biologicsmodular.com
1533 E Northfield Drive
Suite 100
Brownsburg, IN, 46112

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Biologics Modular PPT - 2016

2. Headquartered in Brownsburg, IN, Biologics Modular, LLC, designs, manufactures and sells modular facilities to serve as self- contained biorepositories, biomanufacturing suites 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) • Aseptic Regular Finish Fill • Aseptic with Lyophilization • USP 797 and 800 Compounding Pharmacy • Integrated Facilities • DeployReady Biomanufacturing Suite Partners Summary © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 3

4. The Biologics Modular DeployReady Platform (DRP) is based upon current CGMP manufacturing processes of the FDA regulated industries. Introduction © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 4 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.

10. Modular Design Process Intermodal Container Platform © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 10 Intermodal container platform retains transportation corner blocks, a system that is used all over the world for shipping.

11. Modular Design Process Intermodal Container Platform © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 11 In a few weeks, the container is completely transformed.

12. Modular Design Process Intermodal Container Platform © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 12 A factory acceptance tested clean facility that can go any where in the world.

14. 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 © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 14

15. Aseptic Filling Facility (503B) Aseptic with Lyophilization (VanRx SA25) Pre-Engineered Designs © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 15 Self-Contained Aseptic Filling Facility • Gloveless filling isolator • Fills vials, syringes and cartridges • Integrated sterilization system • Modular platform

16. 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 © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 16

21. 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. © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 21

22. Our DeployReady Platform provides a complete production solution to our clients. Summary Why use Biologics Modular? I. Modular platform provides a more cost effective and shortened time line, compared to a typical stick- built facility. II. Modular platform is scalable and if necessary transportable. III. Experienced design and engineering team to execute clients’ user requirements. IV. Strong partners to help execute necessary implementation strategy for clients. © 2016 Biologics Modular, LLC All Rights Reserved, Confidential www.BiologicsModular.com 22

23.

24. Clark H Byrum, Jr. Biologics Modular President/CEO (317) 456-9191 (Work) (317) 626-4093 (Cell) cbyrum@biologicsmodular.com 1533 E Northfield Drive Suite 100 Brownsburg, IN, 46112

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