Capsugel – now owned by Swiss CDMO Lonza – developed the technology with several biopharma partners, including Pfizer and Eli Lilly, to solve problems surrounding reliable sampling of bioreactors.
Biopharma-Reporter spoke to David Lyon, head of Biotherapeutics for Capsugel, now a Lonza company, on the back of MAST’s win in Frankfurt, Germany last night to find out more:
Biopharma-Reporter (BPR): What biomanufacturing problems does it help solve?
David Lyon (DL): The key problem MAST solves is reliable sampling of bioprocessing reactors. These samples can be delivered to a range of analytical devices measuring titer, metabolites and protein isoforms—all key indicators of product quality. While MAST is fundamentally a sampling system, it enables near real-time sampling and analysis of the bioreactor. This is a critical feature to changing bioprocess development from being recipe driven to being feed-back controlled. Feed-back control of critical-to-quality attributes (CQAs) is an industry-recognized goal and MAST helps enable this solution.
BPR: How did the MAST system come about?
DL: It was developed in response to the problem statements of sampling bioreactors at all scales (demonstrated from 1L to 2000L) and configurations (stainless, glass and single-use reactors) automatically while maintaining sterility, reliably delivering the sample to a wide range of analytical devices; and reliably operating with minimal operator assistance.
BPR: Did you encounter any issues during development?
DL: Clogging of sampling lines when working with high cell density was a particular problem that needed to be addressed when the technology was being developed.
BPR: I believe the tech was originally intended to be deployed in upstream mammalian cell-line manufacturing. How has it since evolved?
DL: It has been subsequently deployed in bacterial processes and downstream applications in mammalian manufacturing.
Interestingly, the original MAST design was aimed at sampling from a single reactor and sending the sample to a single analytical device. As the development program evolved, MAST has become truly modular allowing for the original intent of deploying a “1x1 system” to a level of sophistication that allows us to sample from up to 10 sources and deliver those samples to four independent analytical devices.
BPR: Why was this project developed by Bend Research, predominantly an encapsulating and spray drying company, and how has the acquisitions by Capsugel and then Lonza helped make this system a reality?
While this technology concept was developed as a pre-competitive solution to an industry-wide problem of auto-sampling of bioreactors prior to the acquisition of Bend Research by Capsugel, now a Lonza company, Capsugel continued to incubate the technology through its development and beta-testing phases. Additionally, Capsugel market development assisted in the design and deployment of an independent brand and website.
We launched the commercial version of the sampling technology, the associated software and preventative maintenance programs at Bioprocess International in October 2016. We anticipate widely deploying MAST in Lonza’s internal programs ranging from mammalian manufacturing to cell therapy manufacturing to sterile water sampling for endotoxin testing.
BPR: Who are you targeting specifically with this system?
DL: MAST is targeted at the bioprocessing and fermentation communities as a whole—any clients with automated sampling needs. We have installed MAST systems at 11 companies that range from a simple “1x1” system to multiple “10 x n” systems. Interest in additional installations within existing clients and at new client sites remains strong.
BPR: What sort of response have you had for the system, and how are you looking to go forward with it over the next couple of year?
We have had great enthusiasm within the bioprocessing industry for MAST as we progressed through its development and commercial launch. With the integration of legacy Capsugel/Bend Research into the Lonza network, we are working to integrate MAST into the internal process development manufacturing groups and to collaborate with the Lonza Bioscience Solutions group to continue to offer MAST to the bioprocessing community. We continue to innovate MAST by integrating it with new analytical devices and developing concepts such as low-sample volume and single-use sampling valves.
BPR: David, thank you very much