The Biopharmaceutical Development Program (BDP) develops, manufactures, and provides novel biological agents for early-phase clinical trials when industry is not prepared to develop them.
The program provides leading-edge development and analytical technologies for antibodies, recombinant proteins, peptide and DNA vaccines, virus vaccines and oncolytic viruses, gene therapy products, and other biological and immunomodulating agents.
BDP focuses on products that are in early development and employs a milestone-based approach, beginning with the demonstration of product feasibility in silico and in vitro, followed by process development and biomolecular characterization, culminating in production of Phase I/II clinical supplies.
The program has expertise in production and purification development for manufacturing (preclinical and CGMP), process analytics/quality control, quality assurance oversight/regulatory affairs, and technology transfer.
Among its many successful projects, the BDP developed and produced ch14.18 monoclonal antibody to support clinical trials in pediatric neuroblastoma, a rare type of childhood cancer that presents poor prognoisis for more than half of the children who are affected. Ch14.18 was shown to improve survivability by approximately 50 percent and is now the standard-of-care for pediatric neuroblastoma. The BDP was instrumental in the successful technology transfer of ch14.18 to the commerical licensee.
- Purification of inclusion bodies using PEG precipitation under denaturing conditions to produce recombinant therapeutic proteins from Escherichia coli
- Mammalian cell transient expression, non-affinity purification, and characterization of human recombinant IGFBP7, an IGF-1 targeting therapeutic protein
- Dynamics differentiate between active and inactive inteins
- Enhanced transient recombinant protein production in CHO cells through the co-transfection of the product gene with Bcl-xl