Targeted development of biosimilar pharmaceutical products

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Bioassays addressing multiple MoAs CDC complement dependent cytotoxicity C1 Membrane attack complex Target cell FcγRIIIa Blocking/ Inhibiting RB Dimerization / Shedding / Internalization PCD Effector cell (NK cells) ADCC 24 | Thomas Stangler | EAPB SIG Regulatory Aspects for Bio<strong>pharmaceutical</strong>s | October 4th, 2010 | Business use only Antibody dependent cellular cytotoxicity Programmed cell death (apoptosis )
Factors Impacting Quality: Curse or Opportunity? � Host cell line & clone � Growth medium composition � Culture conditions (pH, T, aeration...) � USP type and regime (fed batch, perfusion...) �� Culture history (genetic stability, process stability...) � Individual DSP steps � Hold times & storage (formulation, container, conditions...) Cell line & process knowledge allows to • use diversity and variability to our advantage • design the desired quality into the product • “to ensure the desired quality, taking into account safety and efficacy” 25 | Thomas Stangler | EAPB SIG Regulatory Aspects for Bio<strong>pharmaceutical</strong>s | October 4th, 2010 | Business use only
Page 1 and 2: Targeted development of biosimilar
Page 3 and 4: Sandoz and Novartis have cutting ed
Page 5 and 6: …and are produced from geneticall
Page 7 and 8: Biosimilars development is a hybrid
Page 9 and 10: Biosimilars: The Regulatory Landsca
Page 11 and 12: Quality: A full quality dossier sup
Page 13 and 14: Biosimilars are recognized around t
Page 15 and 16: Target-directed product development
Page 17 and 18: Starting a biosimilar development p
Page 19 and 20: ICH Q8, Q9 and Q10 19 | Thomas Stan
Page 21 and 22: Elements of QbD Pharmaceutical Deve
Page 23: Typical product quality attributes
Page 27 and 28: Targeted cell line development: Dri
Page 29 and 30: Charge variant (%) 80 60 40 20 0 Ta
Page 31 and 32: QbD for Biosimilars and novel Bioph
Page 33 and 34: Final remarks! � Biosimilars are

Targeted development of biosimilar pharmaceutical products

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