Biologicial Process Development Facility:

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About Us:

Introduction:

The University of Nebraska-Lincoln Biological Process Development Facility (BPDF) is a multidisciplinary "turn-key" facility with over 47 full-time scientist, engineers, and administrative personnel focused on biopharmaceutical process research, development, and manufacturing of candidate vaccines and biotherapeutics derived from recombinant expression systems.

The BPDF is committed to advancing biopharmaceuticals derived from basic research into clinical trials. As scientists bring potential biotherapeutics through discovery, they will need access to qualified scientists, engineers and facilities that understand the complexity of bringing a biotherapeutic to Phase I clinical testing. The discovery team should start interfacing with the process development group at the point where ug to mg quantities of material are needed for initial testing. The process development group can provide guidance on process-related issues to the discovery scientist that will accelerate the transition from discovery to clinical testing. Examples include choosing the right expression system based on post-translational needs, documenting the expression system for ease of establishing a Master Cell Bank, and establishing essential analytical methods for assessing purity and characterizing the biopharmaceutical.

Educational Mission:

As a public university of the State of Nebraska the mission of the BPDF includes serving the needs of the people of the State of Nebraska by educating students, advancing the basic knowledge-base, and acting as a catalyst for economic growth in the State of Nebraska. The academic mission of the BPDF is to: Education in science and engineering focused in bioprocessing, bioengineering and related fields, and to increase the fundamental knowledge basis in bioprocessing and bioengineering through basic and applied research.
Provide a real-world laboratory experience for students in bioprocessing, quality assurance and quality control in a United States Food and Drug Administration (USFDA)-compliant facility.

To accomplish this academic mission a highly-trained staff is required to operate and maintain the facility. The students (post doctoral, graduate and undergraduate) work with faculty and staff in a mentoring relationship. The post-doctoral and graduate students work on project that are non-proprietary and results are published in peer-reviewed journals. Undergraduates are provided opportunities to work in the BPDF laboratories at a multiple of levels with the ultimate job of working in the current Good Manufacturing Practice (cGMP) Pilot Plant. It is only after the student has completed a documented cGMP training program are they qualified to work in the cGMP Pilot Plant.
The BPDF is in the College of Engineering at the University of Nebraska-Lincoln and provides an educational experience for both graduate and undergraduates students in a FDA-compliant facility. Students are involved in cutting edge bioprocess science and engineering in an environment that is under the "umbrella" of Quality Assurance system. Students receive both academic and GLP/cGMP training and exposure to what is required to bringing a safe and efficacious biotherapeutics to the market.

Research Mission

The BPDF has a very strong research and service mission as well:
Expand the knowledge base in biological process research by fostering faculty interaction through access to state-of-the equipment and facilities. Provide assistance to government and industry with process research, development, and early manufacturing of new biotherapeutic molecules for human clinical testing. To be recognized nationally and internationally as a premier bioprocessing facility.
To accomplish these goals it is essential for the BPDF to be a multidisciplinary facility that can meet all of the requirements to bring a biotherapeutic to clinical trials. This starts with a gene that encodes for a biotherapeutic, developing a production strain to express the product, develop a process suitable for cGMP manufacturing, and produce the biotherapeutic under cGMP for Phase I and II clinical trials. To accomplish this the BPDF has 11 distinct laboratories/units, i.e. Molecular Biology, Fermentation Development, Purification Development, Cell Culture Development, Analytical Methods, Protein Characterization, Quality Control-Chemistry, Quality Control-Microbiology, Master Cell Banking, cGMP Pilot Plant, and Quality Assurance. In addition, there is Information Technology, Maintenance, Business Operations, and Administration to assist with operations. Each of these laboratories/units has a dedicated manager and staff. Central to the BPDF is the Quality Assurance Unit, which oversees all quality programs.
The BPDF (originally called the UNL Fermentation Facility) was founded in 1990 as a joint facility between the UNL Food Processing Center and the UNL Center for Biotechnology to serve the fermentation needs of UNL. Initial capabilities included a 5 L fermentor, 4 by 1 L fermentors and a pilot plant with a 60 L fermentor, high pressure homogenizer for cell disruption, and cross flow membrane filtration system for cell harvesting. These capabilities limited the BPDF to fermentation research and development. Over the last 16 years the BPDF has grown from a 2 person operation focused on fermentation research to a facility with a full-time staff of 47 scientist, engineers, and administrative staff capable of providing everything necessary to bring a biotherapeutic to clinical reality.

This issue of Praxis/Practice presents the University of Nebraska-Lincoln (USA) Biological Process Development Facility. Research at the BPDF includes understanding the regulation of the Alcohol Oxidase (AOX) promotor in the methylotrophic yeast Pichia pastoris to the application of neural networking to fermentation control and the integration of molecular biology, fermentation and purification to minimize the effect of endogenous proteases on the expression and purification of recombinant proteins. The BPDF has and continues to work with private industry and non-profit institutions world wide and the United States federal government to bring biotherapeutics to the clinic.