Printer version - CRED Introduction to Biotech and Biopharmaceutical Products

15/11/2016

Introduction to Biotech Products Manufacturing

Stephen Fitzpatrick PhD, Snr. Dir. Regulatory CMC, Biologics, Sanofi Genzyme

ENABLING AND PROMOTING EXCELLENCE INTHEHEALTHCARE REGULATORY PROFESSION

Learning Objectives

 What makes biotech different from a CMC perspective

 Biotech Manufacturing ● Upstream Processes ● Downstream Processes

 Process control and why is it important

 Process-related impurities and contaminants and product related impurities including degradation products

 Process development, improvements and validation

 Critical Steps, QbD, PAT

 Comparability

Please note: The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Sanofi.

History of Biotechnology Products

Regulatory management of biotech products vs small molecules/biologicals differ in many aspects; e.g. history, technology, and product characteristics.

•Completely defined chemicalstructure •Homogeneous

Small Molecules

Since ~1850

•Minimallydefined chemicalstructure • (Very) heterogeneous

Biologicals

Since ~1850

(vaccines & natural, e.g. blood, proteins)

•Partially defined chemicalstructure •Heterogeneous

Biotech Products

Since ~1975

( recombinant DNA products, e.g. mAbs )

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