چکیده (انگلیسی):

Bacille Calmette–Guerin, BCG, is a live attenuated bovine tubercle bacillus used for the treatment of non-muscle
invasive bladder cancer. In this study, an Electrical Sensing Zone (ESZ) method was developed to measure the
particle count and the size of BCG immunotherapeutic (BCG IT), or ImmuCyst® product using a Coulter Counter
Multisizer 4® instrument. The focus of this study was to establish a baseline for reconstituted lyophilized BCG IT
product using visible and sub-visible particle concentration and size distribution as reportable values. ESZ method
was used to assess manufacturing process consistency using 20 production scale lots of BCG IT product. The
results demonstrated that ESZ can be used to accumulate product and process knowledge of BCG IT.
© 2016 Kirkitadze et al.. Published by Elsevier B.V. on behalf of the Research Network of Computational and
Structural Biotechnology. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/).