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