Rotating imageRotating imageRotating imageRotating imageRotating imageRotating image

The Biopharmaceutical Development Program (BDP) at the Frederick National Laboratory for Cancer Research (FNLCR) provides resources and expertise for development of investigational biological agents. The BDP supports feasibility through development and Phase I/II cGMP manufacturing plus regulatory documentation.

Established in 1993, we support the development of monoclonal antibodies, recombinant proteins, therapeutic peptides and DNA vaccines, oligonucleotides, virus therapeutics and vaccines, gene therapy products, and other biological agents. Since our inception, BDP has completed more than 100 projects. The program has released over 225 lots of different products and more than 60 agents have gone into human clinical trials.

Our facilities are designed to be flexible, enabling us to work on multiple projects for a variety of different indications. The BDP provides a unique NCI-funded resource which differentiates it from other biopharmaceutical development programs. The BDP concentrates on products that are in early development to demonstrate feasibility for production of Reference-grade and Phase I/II clinical supplies to be used in first-in-human clinical trials. The BDP has also transferred and recertified commercially manufactured clinical products for use with new clinical indications. BDP expertise and cGMP manufacturing spaces are used by academia and other government agencies for advisory and training purposes.

The BDP is actively looking for outside projects from companies, universities, and government agencies that could be established through a Cooperative Research and Development Agreement (C-CRADA) or interagency agreement. We have a proven track record of partnering with our clients to develop difficult biologic products for preclinical research or clinical trials. The BDP offers a collaborative flexible environment that enables adaptation to the projects needs throughout its life cycle. We offer expert guidance from development through clinical manufacturing and the program is looking for opportunities to assist others with their unmet project needs. If you are interested in learning more about our program and how our resources might help you, please contact Dr. George Mitra, 301-846-5999 or mitrag@mail.nih.gov.

The BDP is developing clinical and non-clinical supplies of rhIL-15 and rhIL-7.

If you would like more information about obtaining supplies or manufacturing and testing documentation please contact
Dr. Jason Yovandich.

 

Document Request

We have over 300 documents online that are available free for any investigator, company, or group developing biopharmaceuticals.