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

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Role of appropriate due diligence studies in validated methods developmentEprex- pure red cell aplasia: analytical standards for analysis of leachates [HSA substitutepolysorbate 80]-Retacrit and Silapo: O-glycan chains and variant of sialic acid detected - different [canine]immunogenicity profiles- Abseamed, Binocrit and Epoetin alfa Hexal: IAC shows different glycosylation patterns viz.higher levels of high-mannose-type structuresKey: EPO is not a single active ingredient – is a heterogenous mix of up to 14 differentisoforms! Isoelectric Focusing analysis of two isoforms shows similar patterns and sialicacid content but very different biological activity e.g in vivo activity of 226,000 U/mg versus400,000 U/mgBurg et al 1998 PCT/EP/98/07876
Underscoring the need for appropriate, harmonized analytics..cation exchange chromatography reveals additional information
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: Role of appropriate due diligence s
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 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 85 and 86:
Learning from History: Making Biosi
Page 87 and 88:
Page 89:
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