Biological Process Development Facility

The University of Nebraska – Lincoln Biological Process Development Facility (UNL-BPDF) is a multidisciplinary “turn-key” facility with 30 full-time scientists, engineers, and administrative personnel focused on biopharmaceutical process research, development, and Phase I/II cGMP manufacturing of candidate vaccines and biotherapeutics derived from recombinant yeast and bacterial expression systems.  The BPDF specializes and is committed to, through its team of experienced scientists and engineers, advancing biopharmaceuticals derived from basic research into clinical trials.  As researchers identify potential biotherapeutics, they need access to qualified scientists, engineers and state-of-the-art process development and early stage cGMP manufacturing facilities that understand the complexity of bringing a biotherapeutic to Phase I clinical testing.  The UNL-BPDF has over 15 years of experience developing processes for over 35 different recombinant biotherapeutic proteins.  The UNL-BPDF also has the ability to manufacture these biotherapeutics under cGMP for Phase I/II clinical studies with our current 60 L capacity cGMP suite.  The UNL-BPDF just completed construction of an $11.2 million Phase I/II cGMP pilot plant with 6,000 ft2 of modular cleanrooms and 7,000 ft2 of support space, including a pure steam generator, WFI condenser, 1000 gal WFI storage tank, and an ambient and hot WFI distribution loop.  The new cGMP facility will have a bioreactor capacity of 150 L working volume (with the ability to accommodate up to a 1000 L fermentor) and all associated downstream processing for both secreted and intracellular products derived from recombinant yeast and bacteria.  This new pilot plant is designed to produce Bulk Drug Substance and has an Aseptic suite with a Class 10 isolator system for manual liquid fill up to 1500 vials.  The current cGMP facility also has the ability to produce Master Cell Banks and Working Cell Banks.

The BPDF has a wide range of experience in recombinant and bacterial and yeast expression systems and is recognized as one the leading expert in the use of Pichia pastoris recombinant expression system. With a focus on producing phase I/II clinical material, the BPDF is able to rapidly develop new processes and produce recombinant therapeutic proteins of the highest quality.

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Locations


United States
Othmer Hall - UNL Campus
304 B Othmer Hall
820 N 16th Street
Lincoln, NE  68588-0668
United States, North America

GMP Experience
Dedicated to Yeast and Bacterial Systems Producion of Master and Working Cell Banks. Phase I/II production of Bulk Drug Substance at the 60 and 150 L Scale

Contacts


Dr. Michael M. Meagher
Director and Professor

Production Lines

Othmer Hall - UNL Campus   cGMP Pilot Plant
Location: Lincoln, NE, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  100L-2000L150L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 15DEC09

Send Inquiry about this Production Line
Othmer Hall - UNL Campus   GMP Suite
Location: Lincoln, NE, United States
Main Details
Specialization:  Drug Substance (API)Drug Substance (API)
Platform:  MicrobialMicrobial
BioReactor Process:  BatchBatch
BioReactor Process:  Fed-BatchFed-Batch
BioReactor Scale:  1L-100L60L Bioreactor
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Biosafety Level 1Biosafety Level 1
Single Use:  NoneNone
Additional Services
Analytical Services are AvailableAnalytical Services
Cell Banking is AvailableCell Banking
Cell Line Development is AvailableCell Line Development
Preclinical Manufacturing is AvailablePreclinical Manufacturing
Process Development is AvailableProcess Development
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Available

Last Update: 15DEC09

Send Inquiry about this Production Line

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