biologics modular ppt - 2016

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.com3

The Biologics Modular DeployReady Platform (DRP) is based upon current CGMP manufacturing processes of the FDA regulated industries.

Introduction



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



Final Site Assembly



Final Assembly•Five Container•Inside Core Build Warehouse


Assembly and Expansion



Deploy-Ready Coupling System (DRCS)


Computational Fluid Dynamics



Simulates the facility design to minimize errors


Intermodal Container Platform



Intermodal container platform retains transportation corner blocks, a system that is used all over the world

for shipping.





In a few weeks, the container is completely transformed.





A factory acceptance tested clean facility that can go any where in the world.

Pre-Engineered Designs


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




Aseptic Filling Facility (503B)Aseptic with Lyophilization (VanRx SA25)




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




Cell Therapy Facilities




DeployReady Biomanufacturing Suite


18www.BiologicsModular.com

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.



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.



Clark H Byrum, Jr.Biologics Modular

President/CEO(317) 456-9191 (Work)(317) 626-4093 (Cell)

[email protected] E Northfield Drive

Suite 100Brownsburg, IN, 46112

biologics modular ppt - 2016

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