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

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ICH Harmonized Tripartite Guideline “Q5E” – [ICH working group, Nov. 2004]“Comparability of Biotechnological / Biological Products Subject to Changes in theirManufacturing Process”Excerpts:1. Physicochemical Properties [ICH Q6B][molecular homo/heterogeneity, higher order structural analysis –secondary, tertiary,quaternary structures]2. Biological Activity3. Immunochemical Properties4. Purity, Impurities and Contaminants[isoforms, degradation products]Analytical TechnologyPost translational modificationsStructural differencesIsomerizationO-glycan characterizationHigher order structuresMonomeric and dimeric forms
Nature Reviews Drug Discovery, 2012, 11, 527-540
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: Biologics Price Competition and Inn
Page 41 and 42: FDA desire for specific innovations
Page 43 and 44: Differences in Sites of Fucosylatio
Page 45 and 46: ETD to analyze formation of isoAsp
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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