The 13th Annual Bioprocessing Summit was a hybrid event this year with some attending in person, others virtually. The 908 Devices team was excited to join in person as it was such a great opportunity to reconnect face-to-face, and shoulder-to-shoulder, with the life sciences community.
But let’s, just for a moment, think about why that in-person opportunity was even possible. As Dr. Sudha Chivukula, Sanofi Pasteur’s head of mRNA technology, so aptly said during her keynote presentation, “It’s thanks to the unbelievable work this community has done on vaccines in the past year which is why some of us could be here in person.”
That leads us to Takeaway No. 1: Real-time process understanding is critical
The sense of joint-community effort, of ‘we’re all in this together’ was downright impressive, especially given where so many of us stood in Aug. 2020. What permeated presentations and conversations this year was the need to embrace faster, more flexible, and more adaptable tools, methods, and processes. When time is of the essence, getting a deeper, real-time process understanding is critical for everything from mAb cultivation to cell and gene therapy (CGT) development.
CGT was a particular point of emphasis among the talks. The ongoing challenge now is to develop CGT faster, bringing costs down to make them more comparable to mAb therapies which currently reach broader populations. That will require the need to leverage more process data towards a deeper understanding of how to model and optimize what happens in a bioreactor and address the regulatory agencies demand for more consistency and standardization.
Takeaway No. 2: Data can’t wait
In her presentation ‘Optimization of Production Bioreactor Feeding Strategy to Mitigate Amino Acid Misincorporation’, Victoria Drake from Alexion Pharmaceuticals Inc, discussed how significant levels of amino acid misincorporation were identified for a mAb produced by CHO cells. Using REBEL’s at-line amino acid analysis to understand when and why this was happening and to circumvent the problem, Drake ran a significant number of amino acid measurements, and benefitted greatly from having the data available within minutes and not days. This allowed her to determine that the amino acid misincorporation levels were correlated with amino acid depletion and unbalanced amino acid ratios. An iterative approach was taken to optimize the production bioreactor feeding strategy to successfully mitigate amino acid misincorporation.
Similarly, our own Graziella Piras, bioprocessing segment director, highlighted the need for greater real-time process understanding at the bioreactor. Adopting new tools like the REBEL analyzer has enabled work at Bristol Myers Squibb to develop better process analytical technologies (PAT) for CAR-T. Other wins from at-line cell culture media analysis included a case study from Clemson University elucidating how cells detoxify from high ammonia environments often encountered in a typical fed-batch bioprocess.
Takeaway No. 3: Leverage all data collected from process to have deeper understanding
From a higher-level perspective, Wolfgang Paul from UCB Pharma shared a keynote titled “Driving Digital Transformation in Cell Culture Process Development,” which emphasized that the industry needs to use data and digital technology to change its business model. He urged attendees to focus more on customer- and outcome-driven results. It is an approach that will require changing traditional ways of working, incorporating new tools in daily work, and making profound changes throughout organizations.
And at the more tactical level, Ruchir Shah from Bristol Myers Squibb shared a talk ‘Automation & Digitalization in High-Throughput Analytics for Bioprocess,’ where he discussed the data management challenge of multiple diverse portfolios of molecules requiring diverse types of assays. To solve the challenge, Shah described a solution that leveraged assay automation, augmented reality data management, and process analytical technology, including data from the REBEL cell culture analyzer. The result was a repeatable method of high-throughput testing offering rapid availability of analytical data for stakeholders.
Takeaway No. 4: New and better analytical methods need to be adopted
The speed at which the industry is making demands of its analytical labs a significant challenge. In his talk ‘High Sensitivity Charge Variant Assessment of Biopharmaceuticals Using ZipChip Microchip Electrophoresis’, Jonathan Bones from the National Institute for Bioprocessing Research & Training (NIBRT) discussed how the need for high-performing analytical solutions encompassing liquid phase separations and high-resolution mass spectrometry, accompanied with supporting bioinformatics has never been higher.
For instance, CE-MS offers a method to characterize charge variants for monoclonal antibodies via native separation that captures selectivity based on differences in surface charge. Due to differential modification of the protein capture the natural dynamic range, this allows for clearer visualization of the different proteomes present. ZipChip ®, coupled to high-resolution Orbitrap mass spectrometer was used as a means for the characterization of charge variants under native conditions. It allowed determination of high numbers of proteoforms, providing deep insight into the distribution of PTMs across these complex molecules. In addition, ZipChip provided impressive separation performance and a huge sensitivity boost using just nanogram quantities of material.
Beyond charge variant analysis, CE-MS with tools like ZipChip have further applications in critical quality attribute analysis, especially as it relates to peptide mapping.
Those are our takeaways, and if you were at the Summit we would love to hear yours as well. Drop us a line at firstname.lastname@example.org.
At 908 Devices, our core focus is to get actionable data in your hands as fast as possible. So while the bioprocessing community continues its ongoing efforts to change the world at warp speed – we’ll be at the ready to assist with technologies that can help.