And if needed, Biologics also provides the resources needed to support system validation, corporate quality, and regulatory support.
Brownsburg, Indiana (PRWEB) March 30, 2011
Biologics Modular has revolutionized the way early stage companies can manufacture FDA regulated products. Woodard Emhardt, LLP, has filed multiple patent applications on behalf of Biologics that cover innovative designs enabling the creation of modular pre-constructed and pre-tested structures.
Typically, the design, engineering, construction, and validation processes of the traditional bricks and mortar approach yield a delivered facility cost of $1000 or more per square foot. The primary reasons for this are the considerable expenses of architectural and engineering fees associated with each “one-off” facility design that must then be amortized within the project. Hundreds of man-hours are spent each time to create a new “Picasso” or “Van Gogh” resulting in a 20,000 square foot space costing $20,000,000.
Biologics Modular utilizes a completely non-traditional, building block approach to facility construction by leveraging intermodal shipping containers. These building blocks are coupled with innovative design elements that enable repeatable modular facility space. Due to the smaller scale volumes of product typical to biopharma research and biotech development and manufacturing, this structured approach is ideal. The result is a one-time design, engineering, and validation model necessary to achieve GMP compliance and FDA facility certification that is flexible and scalable, yet reclaimable and recyclable.
As such, life science companies can quickly and inexpensively move from discovery into production. In a matter of months, any light industrial gray space can be quickly converted into an operational biopharmaceutical production facility utilizing cGMP clean rooms and analytical laboratory facilities.
About Biologics Modular: Biologics Modular manufactures pre-constructed, pre-tested modular clean rooms and laboratory facilities, which enable biotech companies to quickly transition from research through development to production of cGMP product. And if needed, Biologics also provides the resources needed to support system validation, corporate quality, and regulatory compliance.
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