Martin Olbrich, Principal Scientist, Process Research at Roche stated that the biopharma industry must adopt a more sustainable approach to manufacturing and delivering medicines whilst increasing productivity. He suggested that Roche’s digital transformation journey has boosted productivity.
Olbrich identified oligonucleotide chemistry as a good place to implement digital tools. The majority of scientific researchers manufacture oligonucleotides using the following steps: synthesis, purification, desalting, and isolation. These automated processes are amenable to digital integration. Olbrich explained that arguably 95% of compounds in the clinic are manufactured in the same way but depending on the specific molecule and its specific characteristics one may have additional unit operations like a conjugation or second purification.
The instruments and equipment used in oligonucleotide chemistry are prone to digital transformation. Olbrich discussed in detail the manufacturing instruments that could be adapted to enable digital transformation. Firstly, the standard steel synthesisers developed by Cytiva called the OP100 and OP150 have two pumps that deliver reagents to columns. The instruments are equipped with several probes such as UV, pressure, and conductivity to monitor synthesis. This generates high volumes of data to analyse post-synthesis. Olbrich noted that even with expert knowledge, there may be some subtleties in the data that humans cannot comprehend. Particularly in the purification step, the volume of data generated is challenging.
Olbrich explained how the data was stored: “So we have we get the data for all our runs. We want to have it somewhere where we can use it. So, we started to hook up all of our systems to what we call the data lake.” The data lake is a general interface that various systems are connected to enabling comprehensive data storage and comparison across sites. Seeq is a visualisation software that offers live data visualisation, and scientists can remotely interact with the system. Olbrich added: “You can customise your readouts like you could also do with Unicorn. But then you have also the possibility to adjust whatever formula you want.”
For online monitoring, the team can trigger alarms and control the system remotely which has saved thousands of dollars by preventing synthesis failures. Furthermore, Olbrich added that by tracking changes across the synthesis scientists can identify deviations and impurities across development. In summary, Olbrich highlighted the ways in which digital tools offer significant time savings and resource efficiency.