Biopharmaceutical Development Consulting
BDC is an independent consulting firm located in the San Francisco Bay Area. We have over 25 years of research and pharmaceutical development experience working in virtual and start-up biotechs and large pharma. We offer biopharmaceutical development expertise to step in and direct your CMC programs from inception or at any phase in the development cycle in a virtual or established corporate environment. We are GMP trained and familiar with the hurdles of moving various peptide, protein and antibody compounds through pre-clinical development and manufacturing to deliver your drug product to the clinic. Basically, whatever it takes to move your biologic research program into the clinic and through the proof of concept stage and on to advanced clinical trials.
BDC has significant experience identifying and managing outsourced contract manufacturing and research organizations (CMO, CRO) for the following development support services:
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Synthetic Peptide API
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Protein API
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Analytical Methods Development
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Product Characterization
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Pre-Formulation
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Clinical Formulation
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Clinical Assay Development
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Fill/Finish/Labeling
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Microbiology and Sterility
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Release Testing
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Stability Studies
We offer independent strategic review of current program data and can recommend a path forward. We can also help identify a suitable candidate molecule among many to move into drug development.
