Sartorius Innovation Forum 2026

Answered by Franziska Jenner
The Ambr-integrated capacitance probe applies single-frequency measurement to monitor viable cell volume. We have not tried multi-frequency scanning in Ambr bioreactors yet but are evaluating this in larger scale.

Answered by Barry Heavey
Often I observe the KPIs are not defined very well in biopharma industry. I regularly see companies using simple KPIs like “right first time” in areas such as handover of a process from PD to commercial. Minimizing risk (regulatory and quality) always wins out over setting specific and aggressive operation targets for operational excellence. If PPQs are successful then they have achieved RFT, but they may have handed over a process with low titre, suboptimal process capability and the receiving site has many deviations and investigations to deal with in future and long cycle times. This was sometimes accepted because new product launches were not very frequent and a lot changes in the technology of manufacturing in between. So clients focus on reducing risk and not being on the critical path for launch, rather than setting aggressive targets and monitoring lots of KPIs for the next process. They then accept that they will have to invest in developing a 2nd generation process and in this case they will start to focus more on broader KPIs and aggressive targets. But this has to change as the “pace is accelerating” – more new drugs and biobetters coming so ideally clients develop processes that are “Great first time” not just “right first time” and “greatness” is clearly defined with operational excellence KPIs. Then these clients will be able to spend less time investing in 2nd,3rd and 4th generation processes

Answered by Barry Heavey
This is happening all the time in other industries. Think about the automotive industry and the French company Valeo – they develop and contract manufacture complex electronic componentry for car manufacturers (e.g. sensors). They also have to be involved with their clients in the design of exciting new cars, so they know what components will be needed. Highly IP sensitive work. Companies like Valeo manage their R&D work on their most important products in product lifecycle management (PLM) systems. Their clients do the same with their pipeline products (CAD files, specs and tolerances, bill of materials, assembly strategy). The two companies need to provide each other with limited, cloud based access to their PLM systems to ensure they are aligned in every way through the lifecycle from product ideation to prototyping to mass production. But they need to firewall so that Valeo don’t have their IP leaked to other vendors that the client works with and the client doesn’t have their designs leaked to the other clients Valeo work with.
I am not a cybersecurity expert but I take this as an inspiration that this is possible. I am sure it is not perfect, there have probably been “leaks” of data and IP in the automotive industry with this IT architecture. But there are always leaks, even without IT system integration. The pharma industry is just more slow moving and conservative than the automotive industry

Answered by Barry Heavey
I am a big fan of the concept of the “molecule steward” who is responsible for all aspects of the lifecycle of a molecule process optimization – DS, DP and analytical methods. They report on molecule KPIs and targets to senior management and work with all the multidisciplinary team who have contributed, are contributing or could contribute to performance (PD, Reg, MS&T, Ops, eng, QA, QC, supply chain, commercial).
If the molecule steward see a big problem or big opportunity to improve a process (we could intensify upstream, adopt continuous downstream and improve our release assats), they should be able to get the buy-in and resources from senior management to pull together and oversee the multidisciplinary team to make those improvements. They can provide regular updates to senior management to ensure the multidisciplinary team stays focused. But if another molecule steward makes a stronger case for their molecule, then the multidisciplinary resources might be pulled away towards that molecule.

Answered by Adrien Lugari
Cell therapy manufacturers require GMP-grade media with strong regulatory documentation, including CoAs and traceability. Serum-free, Xeno-free and Animal component-free media are highly preferred as they improve safety and consistency. Suppliers must also demonstrate the ability to scale globally with secure supply chains, redundant manufacturing capacity, and dual-sourcing strategies to minimize production risk with low lot-to-lot variations. As regulations around cell therapy is constantly evolving and may vary per country, recurring review of regulatory requirements is advised.