Program Covington: Process Automation & Functional Requirement Specifications
Blood Plasma Therapeutics
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.
This project included development of functional 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
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