ABBVIE BIORESEARCH CENTER (ABC)

The AbbVie Bioresearch Center (ABC) is located in Worcester, located ~ 40 miles west of Boston, Massachusetts. This site, encompassing more than 555,000 square feet of space within two buildings, is our premier biologics research and development center. It offers cell line development, process design and optimization, analytical characterization, quality control testing, validation, cGMP manufacturing and regulatory support for the development and commercialization of biopharmaceutical active pharmaceutical ingredients (APIs). It also offers antibody drug conjugation. The dedicated biologics manufacturing space occupies over 104,000 square feet of the site.


ANTIBODY PRODUCTION PROCESS

Many of the products manufactured at ABC are monoclonal antibodies (or "MAbs"). In broad terms, these processes are pretty similar, differing in such areas as the specific buffers used in chromatography, the number of process steps in purification and the specific filtration and chromatographic media used. This map depicts a MAb process in a generic manner.

Each of the purple and orange blocks represents an area (typically a suite).


Fermentation


Cell Culture

The cell culture operation grows the cells in number and concentration and induces the cells to produce the product protein.

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Downstream Purification

 

Harvest Operation

The harvest operation clarifies the process stream from the bioreactor following the cell culture operation.



Capture Operation

The capture operation first prepares the process stream by adjusting its concentration and putting it into a buffer suitable for loading a chromatography column. Then, the operation runs the first chromatographic separation of the process.

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Purification

Purification areas run several unit operations downstream of Capture. These include:

  • Chromatography
  • Ultrafiltration (UF)
  • Viral Filtration
  • Bulk Fill

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Buffer Preparation

Buffers are prepared in two areas: "Small-scale Buffer Prep" handles solutions up to about 1500 liters, and Large-scale Buffer Prep handles solutions up to 6000 liters. The resulting solutions are sent in buffer bags inside buffer tubs or totes, or they are send in portable stainless steel tanks or they are piped to tanks in other areas.

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Media Preparation

Media are prepared in two areas: "Small-scale Media Prep" handles solutions up to about 200 liters, and Large-scale Media Prep handles solutions up to 6000 liters. The resulting solutions are sent in buffer bags inside buffer tubs or totes, or they are send in portable stainless steel tanks or they are piped to tanks in other areas. Sometimes, the media is pumped directly through a filter train into a bioreactor.

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Weight / Dispense

Weight / Dispense is the area that prepares the required amount of each material for later use in each solution. Most of the components used to make a buffer or media are pre-weighted in this area (only the largest components get weighed directly into a mix tank). Weigh / Dispense is a part of Core Support.


Glasswash

The glasswash areas clean and sterilize equipment that is not cleaned in the suites. This includes all of the small parts and many piece of mobile equipment. This area also performs filter integrity testing.

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Logistics

Logistics operates the GMP Warehouse and the Shipping area. They also manage movement of materials to and from our contracted offsite storage facility.

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Maintenance

The Maintenance Department is staffed by technicians with a variety of specialties, including mechanical, electrical and metrology staff, as well as other specialities, some contracted.

Maintenance staff also maintain and operate the utilities.

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Utilities

Dozens of utilities (pipes, ducted and wired) serve the plant, enabling production.


Control Systems

AbbVie Bioresearch Center has state-of-the-art control systems, including:

  • Foxboro I/A Series Distributed Control System
  • Allen-Bradley Programmable Logic Controllers and PanelView Operator Interfaces
  • Johnson Controls Metasys Building Management System
  • OSIsoft PI Process Historian
  • newView Event Logging System
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