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University of Nebraska–Lincoln

Biological Process Development Facility

About Us

About Us
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Our Mission

The BPDF has a three-fold mission statement defining our commitment to student education and quality improvement. At BPDF, our mission is to:

  1. Educate students in the field of bioprocessing and biotechnology, providing exposure to the regulatory constraints of an FDA compliant facility.
  2. Increase the knowledge base of bioprocessing and biotechnology with the objective of improving the manufacturing and quality of biotherapeutics.
  3. Facilitate the transition of our clients' biopharmaceuticals from discovery to clinic by applying process development, technology transfer, and cGMP manufacturing. We accomplish this by empowering our employees and applying our shared values to every task to achieve customer satisfaction.
Our Past

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 just fermentation research and development.

Our Present

Over the last 18 years the BPDF has grown from a 1 person operation focused on fermentation research to a facility with a full-time staff of 29 scientist, engineers, and administrative staff capable of providing everything necessary to bring a biotherapeutic to clinical reality.

The BPDF is a leading process research facility in the development of vaccines and biotherapeutic derived from recombinant yeast and bacterial expression systems. We have worked on projects ranging from process research, development, and cGMP manufacturing of vaccines against biological warfare agents for the US Department of Defense to assisting small and large biopharma companies bring biotherapeutics to clinical trials for indications such as cancer, autoimmune diseases, cardiovascular, and other vaccines.

Our Future
At the BPDF, our future is today. A new $11.2 million Phase I/II cGMP pilot plant completed construction on Dec 31, 2008. This facility was designed and built by AES Clean Technology and BioKinetics, Inc and has 6,000 square feet of cleanrooms and 7,000 square feet of support space. The cGMP pilot plant has a 200 L bioreactor with the space to accommodate up to 1000 L bioreactor and all associated downstream processing for either secreted and intracellular products derived from recombinant yeast and bacteria. The pilot plant has an Aseptic Suite equipped with a multi-purpose Class 10 isolator system that is sterilized with vaporized hydrogen peroxide and can be used for manual fills. The support space houses raw material receiving, final product storage, and 5 validated stability chambers. The cGMP utilities are located in this space and include a EDI water pretreatment system, a pure steam generator with a WFI condensor, 1000 gal WFI storage tank, WFI distribution system for both ambient and hot WFI, a dedicated chilled water system that circulates 40 F water through the facility at 270 gpm, process and biowaste treatment system and an electrical system that is hooked up to a dedicated emergency generator and an uninterruptible power supply. Commissioning and validation is expected to be completed by 4th quarter 2009.