Spring Intro 2023

06/03/2023

Manufacturing and Quality

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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A typical biotechnology manufacturing process includes multiple stages 1-2

Transfection of DNA into cell

A Living Process

Injection into Patient

Cell Line Selection and Development

Refrigerated Storage and Transport

Establishing a Master Cell Bank

Formulation Fill and Finish

Isolation and purification

Characterisation and Stability

Cell Culture and Expansion

[ 1 Kresse GB, et al. Eur J Pharm Biopharm 2009;72:479-86; 2 Sharma BG. EJHP Practice 2007;13:54-6]

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