The BPDF assists university researchers, commercial companies, and not for profit organizations with the development of GMP-compliant manufacturing processes and test methods for early stage biopharmaceuticals, and produces bulk drug substances suitable for non-clinical and Phase I/II clinical trials. The BPDF also produces bulk intermediates for further processing, as well as industrial and agricultural enzymes, following appropriate GMP requirements
Design and optimization of production processes and all GMP manufacturing activities are performed in compliance with the BPDF’s Quality System, as described in the BPDF Quality Manual. The Quality System is designed to meet the requirements of U.S. 21CFR Part 11 and Parts 210/211, ICH Q5C, Q5D, Q7, Q10 and Q11, as well as applicable Eudralex Rules and compendial standards (USP/NF, Ph.Eur.).
To ensure that Quality System requirements are met and maintained, the Quality Assurance group performs periodic internal audits and encourages external quality audits of the facility and system. Prospective clients can request a quality audit. We can provide documentation for a desk audit or schedule an on-site audit.
For additional information contact Sandra Williamson, Quality Systems Manager at swilliamson3@unl.edu.
Regulatory Affairs
The BPDF assists government agencies, biotechnology companies, academic researchers, and non-profit organizations with the development of GMP-compliant manufacturing processes and test methods. To ensure quality and regulatory compliance at all stages of development, the BPDF collaborates with clients to develop regulatory strategies, provides support for registration dossiers, including submission ready documentation, and assists with post-submission responses to regulatory bodies.