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Licensed Biological Products with Structural Heterogeneity

Licensed Biological Products with Structural Heterogeneity. Andrew C. Chang, Ph.D. Associate Director for Policy and Regulation Division of Hematology, CBER, FDA BPAC, Gaithersburg, MD November 4, 2005. TOPICS TO BE COVERED. Structural Heterogeneity of Biological Products: Case Studies

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Supplementary Figure 1

Nephrin. Nephrin. Nephrin. Nephrin. Nephrin. Synaptopodin. Synaptopodin. Synaptopodin. Synaptopodin. Synaptopodin. A. Merge. Merge. Merge. Merge. Merge. B. Podocin. Podocin. Podocin. Podocin. Podocin. Day 28. Control. Day 3. Day 15. Day 7. ADRN 11 mg/kg. Cont. Day3.

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Supplementary Figure 1

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SPP1

B. A. Vector. RAR ?2. SPP1 protein. Vector #1. Vector #2. RAR ? #2. RAR ? #1. SPP1. 1.5 kb. - 210 kDa - 135 kDa - 82 kDa - 39 kDa - 32 kDa. SPP1 66 kDa ?. 36B4. 1.3 kb.

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Licensed Biological Products with Structural Heterogeneity

Supplementary Figure 1

Supplementary Figure 1

SPP1