Learning from History: Making Biosimilars a Reality - Genetic ...

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Relative AbundanceLC-MS-NMR and micro-NMR:-analysis of heparin O-glycans1008015.80458.5815.95458.67base peak60402001003.91433.585.64433.5815.05427.5813.60574.0817.02711.5817.38972.4217.77527.0023.85725.2525.01580.1728.04792.8329.43843.588060Hex 5 GlcNac 240micro–NMR has high20sensitivity for LC-isolatedanalytes 06.72972.0810.39972.1713.66972.0816.32972.7517.2918.04972.5821.84972.5024.81972.3327.41972.9230.62972.58Tryptic GlycopeptideStructural Reporter Groups Resolved(RNase B shown)NMR solved the Heparin Crisis 11 Guerrini … Sasisekharan. Nat. Biotech 26(6) 669-675 (2008)
ETD to analyze formation of isoAsp [isomerization of Asp /deamidation of Asn]: amyloid bisoAsp can beimmunogenic0.1Enrichment of isoD by Asp-N digestionbefore digestionafter digestion0.08Maximum, 100% isoDz 10-57/z 100.060.040.02Anal.Chem., 82, 7485 (2010).00% 1.9% 3.7%Spiked isoD percentage
Page 1 and 2: Learning from History: Making Biosi
Page 5 and 6: OverviewWhy biosimilars?QbD and the
Page 7 and 8: © Sandoz 2012By 2016, 7 of the top
Page 9 and 10: Biologics are more complex than sma
Page 11 and 12: Biosimilars must be systematically
Page 13 and 14: QbD biosimilar product specificatio
Page 15 and 16: Fingerprint mAbs/Fusion proteins as
Page 19 and 20: Exaggerated expectations for Biosim
Page 21 and 22: SPR real time binding assay much mo
Page 25 and 26: UK example:Biosimilars expand acces
Page 27 and 28: Analytical Characterization of Biop
Page 29 and 30: Amino acids ->peptides->proteins->P
Page 31 and 32: Tissue PlasminogenActivator [tPA]:
Page 33 and 34: Role of appropriate due diligence s
Page 35 and 36: Underscoring the need for appropria
Page 37 and 38: Biologics Price Competition and Inn
Page 39 and 40: Nature Reviews Drug Discovery, 2012
Page 41 and 42: FDA desire for specific innovations
Page 43: Differences in Sites of Fucosylatio
Page 47 and 48: High order structures ofvery comple
Page 49 and 50: Ability to assign structural change
Page 51 and 52: Nature Reviews Drug Discovery, 2012
Page 53 and 54: size exclusionchromatography (SEC)a
Page 57 and 58: Are the Molecules Similaror are The
Page 59 and 60: Focus of GuidanceQualityScientificS
Page 61 and 62: A Stepwise Approach to Demonstratin
Page 63 and 64: Our Focus: PK & Immunogenicity•Ou
Page 65 and 66: Typical ELISA Method for PK Determi
Page 67 and 68: Best Practice for Side by SideCompa
Page 69 and 70: Progression of Immunogenicity Testi
Page 71 and 72: Antibodies Can Cross React with Mul
Page 73 and 74: Why Conduct an Immunogenicity Asses
Page 75 and 76: Antibody Characterization: Binding
Page 77 and 78: Cell Based Assays:Product Release a
Page 79 and 80: Target Cell and Neutralizing Antibo
Page 81 and 82: Corporate OverviewIllinoisWIL Resea
Page 83 and 84: Thank YouMarie Rock, Ph.D.
Page 89: Learning from History: Making Biosi

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