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Biopharmaceutical

Abbott offers state-of-the-art process design, analytical characterization and cGMP manufacturing in support of development and commercialization of Biopharmaceutical drugs.

We provide a wide range of process development service, from cell line and process development, optimization, characterization and validation, to 300L pilot scale production and seamless transfer to Clinical or Commercial Manufacturing. Our multiuse cGMP facility in Worcester, MA is licensed for commercial production of Humira® by the FDA, EMEA, Canada, and other Regulatory agencies. Four independent suites containing multiple 3,000L and 6,000L bioreactors each are designed to support projects through commercial production. The expertise of our Process Sciences, Protein Analytics and Characterization, Engineering, Manufacturing, Quality, Regulatory and Project Management groups ensures the smooth transition of every project from research to commercialization.

Abbott Bioresearch Center has a proven track record of successful collaborative development and manufacturing partnerships. We have worked with companies such as ZymoGenetics, Inc., Seattle Genetics, Inc., and TolerRx, Inc. in process development, characterization, and manufacturing of one or more of their pipeline products. We apply the experience gained through development of our internal pipeline and the successful development, registration, launch and commercial production of Humira® (the first fully human monoclonal antibody) and apply this to our client’s products as if they were our own.

Download our fact sheet from the Worldwide Locations (Worcester) section of this Web site for more information.

Currently Available Equipment
1,000 – 6,000 liter mammalian cell culture bioreactors
Up to 5,000 liter fixed process tanks
Up to 1,200 liter portable process tanks
Alfa Laval BTPX-710, two-BTUX-510s, STPX 205 centrifuges
Up to 100 LPM cross flow filtration skids
Up to 500 LPH chromatography skids
Up to 200 liter chromatography columns
Extensive use of disposables
 

 

 

 

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