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

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“Acceptable changes in quality attributes ofglycosylated biopharmaceuticals”2,01,61,20,80,40,0Unfucosylated G0[% of glycans]08.2007 12.2008 05.2010 09.2011Expiry Date1401201008060Pre-ShiftADCC Potency[% of reference]Pre-ShiftPost-ShiftPost-Shift08.2007 12.2008 05.2010 09.2011Expiry DateSchiestl, M. et al., NatureBiotechnology 29, 310-312, 2011)• Monitoring batches of anapproved mAb revealed ashift in quality• Shift in glycosylation(structure) pattern resultsin different potency incell-based assays(function)• Indication of a change inthe manufacturingprocess• Sandoz observed suchshifts in several originalproductsDifference to post-change versionsometimes greater than to biosimilar12 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, September 2012
QbD biosimilar product specifications impacted byvariability in originator product• Analytical methods are sensitive to differentiate betweenBatch to batchBatches before and after a change of the manufacturing processBatches from different sites• Analytical methods candetermine whether batchessourced in different countriesare identical or notMicroheterogeneity of protein structure» Purity profiles» Glycan distribution% G2F605040302010Enbrel ® batches - G2F amountsUS LyoUS LiqEU US Lyo LiqEU LyoEU Liq LyoEU LiqEU LiqManufacturingprocess changeSchiestl, M. et al., NatureBiotechnology 29, 310-312, 2011)001.2007 02.2008 03.2009 05.2010 06.2011Expiry dateAll trademarks are the property of their respective owners.13 | Genetic Engineering & Biotechnology News Webinar on Biosimilars, September 2012
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: Biosimilars must be systematically
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 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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