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Program Covington: Process Automation & Functional Requirement Specifications

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, wa/company”rehousing, central utilities,administration administration, and laboratory facilities.

Sequence Scope: Functional Requirement Specifications

This projectincluded development of functional requirement specifications to define general and sequential functionality of the facilities, utilities, and process equipment per ISA-S88 standards to commercially manufacture blood plasma derived therapeutics on a DeltaV DCS platform with ~17,500 I/O.

Utilities included: WFI, RO, Compressed Air, Clean Steam, Alcohol, etc.)

Process Equipment included: Ultrafiltration/Diafiltration, Centrifuges, Filtration, Chromatography Skids, Buffer Preparation and associated CIP
Client
Takeda (formerly Baxter, Baxalta, and Shire)
Location
Covington, GA
Blood Plasma Therapeutics

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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