Modular Automated Technology Allows Multiple Bioreactor Sterile Sampling

Capugel, a Lonza company, received the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing for its Modular Automated Sampling Technology (MAST) platform. The technology allows for the collection of up to 10 sterile sample sources and can distribute those samples to multiple analytical devices for automated analysis. The modular nature of the MAST platform means that the technology can be customized to individual customer needs and bioprocesses. Pharmaceutical Technology spoke with David Lyon, senior advisor to the MAST program, Lonza Pharma & Biotech (LPB), on how this technology is changing the biomanufacturing landscape.

PharmaTech: How does MAST technology ensure sterility during the transfer of samples from the bioreactor to multiple analytical devices?

Lyon (LPB): MAST-Modular Automated Sampling Technology-was developed with partner companies like Pfizer, Lilly, and a number of other biopharma companies in response to the problem statements of automatically sampling bioreactors at all scales (demonstrated from 1 L to 2000 L) and configurations (stainless-steel, glass, and single-use reactors) while: 1) maintaining sterility; 2) reliably delivering the sample to a wide range of analytical devices; and 3) reliably operating with minimal operator assistance-clogging of sampling lines when working with high cell density cultures was a particular problem that needed to be addressed when the technology was being developed. Sterility of the bioreactor is assured by the use of interlocks in our sample pilot valves (SP-100 for steam-in-place bioreactors and the smaller SP-200 for cell culture applications). The use of an interlock means that the valve cannot be simultaneously open to both the bioreactor and the external environment. Furthermore, MAST uses a sanitant flush between sampling protocols, ensuring that the valve is sterile prior to taking the next sample-again, preventing exposure of the bioreactor to the external environment.

PharmaTech: What is the significance of eliminating operator involvement?

Lyon (LPB): Although manual sampling of bioreactors is common at many bioprocessing facilities, the key risks that come into play in a manual sampling strategy are that the reactor’s sterility may become compromised and that the frequency of sampling can be insufficient. MAST allows sterile sampling-tens of thousands of samples have been taken without contamination, compared to typical contamination rates of 2%–3%-and samples can be taken 24-hours a day, 7-days a week without having to bring operators into work over weekends or at night. By adding a Gilson liquid handler to the MAST system, samples can be taken as frequently as desired and retains maintained in 2–8 ^oC storage until a scientist or operator is available to transfer the samples to a more permanent storage arrangement.  Additionally, MAST can be made GMP-compliant, which means that data traceability and integrity can be improved over a manual system.

PharmaTech: Can you give an example of how this technology can be custom tailored; is there a case study you can reference?

Lyon (LPB): MAST was developed to be a modular system. This allows custom installations that range from ‘1x1 system’-that allows sampling from a single source with delivery to a single analytical destination-to a level of sophistication that allows us to sample from up to 10 sources and deliver those samples to four independent analytical devices. With the inclusion of a Gilson autosampler, we can also enable sample post-processing (for example, Protein A purification), sample-retain storage and sample delivery to virtually a limitless number of analytical devices. The sample sources-glass, stainless steel, and single-use equipment-have been sampled, and the analytical destination can be customer-defined. We have connected to more than six different analytical devices and are in the process of connecting to new destinations every month.

PharmaTech: How widespread is the adoption of this new MAST technology at present, or is it still in the early stages of deployment to the industry?

Lyon (LPB): MAST was launched commercially in October 2016. While we are still in the product-launch phase, we have successfully installed 12 MAST systems in 10 different companies. The industry response to MAST has been very positive as demonstrated by the number of early adopters and the receipt of the recent CPhI Innovation Award for Excellence in Pharma: Bioprocessing, which we accepted in Frankfurt in October 2017.