A modular and multi ‐functional purification strategy that enables a common framework for manufacturing scale integrated and continuous biomanufacturing
This study utilized an Apollo™ X CHO-DG44 mAb-expressing cell line in a steady-state perfusion bioreactor, harvesting product continuously with a cell retention device and connected SymphonX™ purification skids. The dow nstream process used the same chemistry (resins, buffer composition, membrane composition) as our historical batch processing platform, with SymphonX™ in-line conditioning and buffer concentrates. We used surge vessels between unit operations, single-column chromatography (protein A, cation and an ion exchange) and two-tank batch virus inactivation. After the first polishing step (cation exchange), we continuously pooled product for 6 days. These 6 day pools were processed in batch-mode from anion exchange to bulk drug substance. This manufacturing scale proof-of-concept ICB produced 0.54 kg/day of drug substance with consistent product quality attributes and demonstrated successful bioburden control for unit-operations undergoing continuous operation.
Source: Biotechnology Progress - Category: Biotechnology Authors: Leon P. Pybus,
Charles Heise,
Tibor Nagy,
Carmen Heeran,
Terri Dover,
John Raven,
Junichi Kori,
Graeme Burton,
Hiroshi Sakuyama,
Benjamin Hastings,
Michelle Lyons,
Shinichi Nakai,
Jonathan Haigh Tags: RESEARCH ARTICLE Source Type: research