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Program Covington: MES Engineering Support

lood 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.
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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Tulip

No Code App Development for Manufacturing Operations

Tulip creates user-friendly and functional apps that improve the productivity of operations, without writing any code. Users can start from scratch or customize an App Template to fit their needs.

Sequence partners with Tulip for implementation and validation of the Tulip platform as well as creation, configuration and validation of Tulip Applications that are hosted on the platform. Our application builds include Electronic Batch Records, Weigh and Dispense, Digital SOPs for training (with embedded videos) and more.

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