Register  /  Login               

cGMP commercial scale oligonucleotide synthesis
From equipment design concept to system qualification

MICHAEL LI1*, BRIAN CRAWFORD1, CARLY HERERRA1, WAYNE DAVIS2*, HAGEN CRAMER2, NATHAN BREMER2
*Corresponding authors
1. Asahi Kasei Bioprocess, 1855, Elmdale Avenue, Glenview, IL 60026, USA
2. Girindus, 8560 Reading Road, Cincinnati, OH 45215, USA

Abstract

A fully automated flow-throughsynthesizer connected to adynamic axial compression (DAC) column reactor wasdesigned to perform commercial scale oligonucleotidesynthesis. Aspects of the system design which support scaleup,tech transfer to/from other sites and alternative equipmentdesigns are reviewed. The systems were extensively testedduring manufacturing and start-up. Both the IQ (InstallationQualification) and the OQ (Operational Qualification) weremodelled on the testing done by the system designer prior todelivery. The PQ (Performance Qualification) of the synthesizerwas done synthesizing a “reference” oligonucleotide at fullproduction scale for the instrument of 120 mmol. The sameoligonucleotide had been previously made at Girindus on adifferent system at a smaller scale so a performancecomparison could be made. Manufacturing science can beused to develop an understanding of a process and identifycritical parameters that may affect a process. The high yield ofthe 13-mer oligonucleotide synthesized by the cGMPcommercial scale synthesizer is an example of a controlledmanufacturing process.


...



About us



tks | publisher, event organiser,
media agency

Viale Brianza, 22
20127 - Milano - Italy

info@teknoscienze.com
Tel. +39 02 26809375