The Nebraska Nanomedicine Production Plant (NNPP) provides contract development and manufacturing support services to academic institutions, startups and large pharmaceutical companies. We support US Food and Drug Administration (FDA) compliant batch scale-up of candidate nanoformulations for production, new drug applications, phase 1 clinical trials and technology transfer for large scale production. The NNPP serves bench to bedside production and quality control development for human drug testing. A staff of senior nanotechnology experts is supported by experienced manufacturing personnel and quality assurance professionals in advising and executing product development to serve the nation and world.
Pharmaceutical companies and individual scientists with novel advanced plans for nanomedicine product development are encouraged to contact us.
The NNPP is comprised of two state of the art facilities offering a 'one stop shop' for all nanoproduction needs. Our Pre-Production facility follows good laboratory practice (GLP) guidelines for scale-up production development and process capability studies. Our Manufacturing facility follows current good manufacturing practice (cGMP) guidelines for highly regulated production of nanomedicines, safety assessments and early phase clinical trials.
The NNPP can provide counsel, equipment and technological support to speed product manufacture for any enterprise working in the field of nanoformulations. Few pharmaceutical manufacturing facilities are able to rapidly trouble shoot then scale up products requiring on site management by experienced scientific teams, as the NNPP is able to forge. The broad expertise in medicinal and polymer chemistry affords the NNPP unique opportunities for proof of concept inventions and sets it apart from other companies in the field.
Pre-Production Advisement and Product Preparation
- Advice on product preparation and quality control measures
- Work with experienced nanotechnologists and medicinal chemists
- Laboratory support offered within the University of Nebraska Medical Center academic research groups
- Follows GLP guidelines for optimizing production, purification, lyophilization and characterization of all nanoformulations
Projected opening date of February 2016
Final Product for Manufacture and Quality Control
- Experienced staff oversees a well-equipped and Food and Drug Administration compliant facility within Nebraska Medicine's Biologics Production Facility
- Facility complies with cGMP guidelines for regulated production of candidate nanoformulations
- State of the art manufacturing facility
Projected opening date of August 2016
The Nebraska Nanomedicine Production Plant provides a unique resource to transition nanomedicines from preclinical screening to human clinical trials.