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Program Covington: MES Support

Blood Plasma Therapeutics

Overview

Shire (now part of Takeda) built a 100-acre greenfield campus in Covington, Georgia. The campus includes over 1.0 million square feet of building space that was built to manufacture human plasma-derived drug substances and dosage form products. The site includes facilities for plasma testing, fractionation, formulation and filling, packaging, warehousing, central utilities, administration, and laboratory facilities.

Sequence Scope

This project included development of functional specifications for the Electronic Batch Management (EBM) system per ISA-S95 standards on a Siemen XFP MES platform.

Sequence also performed system configuration of the EBM process instructions to support manufacturing in the Fractionation, IG, and Albumin process areas.

Life Impact

  • The Takeda state-of-the-art facility is providing much needed additional capacity for meeting increasing global demand for plasma-derived therapies. Ig is a critical treatment for primary immunodeficiency (PI) diseases in which part of the body immune system is missing or functions incorrectly.

  • Manufactured drugs include FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is indicated for hypovolemia, hypoalbuminemia, (burns, Adult Respiratory Distress Syndrome (ARDS), and nephrosis), cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN), Immuno Globulin. Source

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