After hearing the news of Cytiva and Syvento Bitotech's new facility, European Pharmaceutical Manufacturer followed up with Ludovic Brellier, president of Hardware Solutions at Cytiva, for more information.
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How does partnering with Cytiva ensure a reliable and efficient supply chain for critical components and consumables?
At Cytiva, we have an in-region for-region manufacturing footprint paired with a regional distribution network to drive fulfilment responsiveness and security of supply.
How will the FlexFactory contribute to accelerating the development and commercialisation of new mRNA therapies?
Cytiva solutions provide biomanufacturers, such as SyVento, with the ability to develop and manufacture a therapy in one single location in pre-determined and fixed timelines, effectively eliminating the need for time-consuming transfers between vendors. Our suite of automation and digital tools, including the Historian automation system, is specifically designed to accelerate your operations. With these digital tools you can optimise bioprocessing workflows, minimise risk, and reduce both costs and time from your operations.
What impact will the increased manufacturing capacity have on patient access to innovative mRNA treatments?
The industry is merely scratching the surface of mRNA's vast potential. Harnessing mRNA technology allows for the potential creation of an array of new drugs designed to tackle a wide variety of diseases. Equipped with an mRNA FlexFactory manufacturing platform in your facility, you're empowered to rapidly and efficiently produce diverse drug types and distribute them to the patients who need them the most.
How will the FlexFactory contribute to the growth of the Polish pharmaceutical industry and foster innovation?
The FlexFactory enables an “in-region, for-region” manufacturing strategy. Its flexibility makes it easily adaptable to a range of therapeutics from personalised medicines to large batch manufacturing. As the needs of SyVento’s customers change, they will be able to respond quickly using the FlexFactory platform.
How does the FlexFactory's modular design enable it to adapt to future changes in demand or technological advancements?
In biomanufacturing, navigating risks and adapting to change are part of the journey. Expanding capacity to embrace new products or meet a sudden increase in demand brings its own challenges. With the FlexFactory platform’s modular design and a highly trained team at the ready, biomanufacturers can scale up and out swiftly enabling a rapid response when needed.
How does the Historian automation system address data security and privacy concerns, especially when handling sensitive patient data?
In a nutshell, we don't collect any patient data. Our focus is entirely on process data, which is separate from patient data. Even when tied to a batch, the only connection is an anonymised batch ID. Examples of process data include parameters like pH, temperature, and oxygen levels from each batch or lot. For monoclonal antibodies (mABs), there's absolutely no patient data involved. In the case of CAR-T therapies, while it’s a 'batch of one', the batch ID remains anonymised, and the data generated is strictly in-process data from procedures like expansion and transfection.