As a part of the expansion, the contract development and manufacturing organization (CDMO) has optimized the site's Quality Control (QC) and analytical laboratory layouts and technologies and added five Waters Arc Premier LC Systems and two Acquity Premier Chromatography Systems.
“The investment in analytical capabilities at our Bristol site enhances our existing capabilities to characterize processes as they are being developed and manufactured,” Louise Duffy, chief technical officer (CTO) for Abzena, told BioProcess Insider.
“As bioconjugation methodologies have expanded and become much more site-specific, it is crucial to have the widest range of analytical technologies to be able support these processes. We understand how the antibody drug conjugate (ADC) market is developing and we are making investments in Bristol to stay at the forefront of the industry.”
Duffy said, in developing integrated bioconjugation and ADC programs, it is important to be able monitor the molecule and process attributes at every step of the way. “The input materials for any conjugation need to be fully characterized, so it is well understood how the conjugation process will perform to ensure the right outcomes for safety, efficacy, and purity.”
“With the evolution and expansion of bioconjugation technologies in the last few years the ability to monitor processes at every step of the way is paramount and has necessitated the introduction of new analytical methodologies. This will serve our customers by providing robust development programs that meet regulatory expectations,” said Duffy.
The CDMO has also added Sartorius’ Hipersep equipment. The process purification equipment is designed for the large-scale high-pressure purification of complex organic molecules, such as linker-payloads. It will provide increased capacity for developing and manufacturing linker payloads for ADCs.
In 2018, Abzena named Sartorius as its preferred bioprocessing vendor within its US operations, following which the CDMO added two 500 L bioreactors and one 2,000 L bioreactor supplied by Sartorius at its San Diego facility in November 2018.
The firm confirmed it had additional plans for investments at its Bristol site that will be completed over the course of 2024.
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