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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.

Capabilities

The BDP is a CGMP compliant pilot facility for process development, preclinical and clinical manufacturing, and testing with Quality Assurance/Regulatory support for novel biopharmaceuticals.

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Free GMP Documents

We have over 300 documents (e.g. SOPs for QA systems) that can be requested and emailed for free to any investigator, company, or group developing biopharmaceuticals.

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.

Scientest in lab

About the BDP

We support the development of monoclonal antibodies, recombinant proteins, therapeutic peptides and DNA vaccines, oligonucleotides, virus therapeutics and vaccines, gene therapy products, and much more.

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Contact the BDP

Most requests can be directed to:

George Mitra, Ph.D.
Program & Technical Director
Phone: (301) 846-5999
Fax: (301) 846-6203

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