Top insights include process intensification, rapid decision making, impurity analysis, and metabolite monitoring
Biotech Week Boston 2021, which includes BioProcess International and TIDES Oligonucleotide & Peptide Therapeutics, was a jam-packed hybrid event. We were thrilled to attend and learn how new ideas, science, and technology are accelerating the biotechnology business.
At the top of everyone’s thoughts? The ongoing pandemic and the continued debate about mRNA vaccines. Dr. Katalin Karikó, Sr. VP of RNA Protein Replacement Therapy at BioNTech, shared the fascinating story of the long road she traveled to make mRNA vaccines possible during her keynote presentation. While public perception is that mRNA vaccines have only been in the works the past year, leading to some vaccine hesitancy, the underlying science and technology have actually been in the works since the 1970s. So the general public may not be aware of how much we already knew about mRNA as a therapeutic molecule and ways to avoid an inflammatory response and methods to deliver these safely into cells..
So, what else was covered?
Takeaway No. 1: Increasing efficiency using process intensification
Everyone is trying to get the next life-saving therapeutic out as quickly as possible at a lower cost. One approach is by improving manufacturing productivity through process intensification. This can either be an intensification of one step in the manufacturing process or it can be more complex to encompass multiple steps. Andrew Falconbridge from Alvotech described how they were able to increase titer by moving from a batch process to a hybrid continuous perfusion process – for more than a 3x increase in product production plus a reduction in time and cost.
Regardless of the approach to process intensification, more data is the key to success. Whether that is with multivariate data analysis or frequent, at-line cell culture media analysis with the REBEL, more data allows for better process understanding and scalability.
Takeaway No. 2: The importance of online analytics and rapid decision making
There is also a push to evaluate bioreactor cells online to facilitate rapid decision-making capabilities. As described by Katrina Janiszewski at Takeda, offline sample testing approaches have long data turn-around times, are expensive, and require intensive resources. Nobody has time for that! Takeda successfully developed an on-line bench-scale bioreactor with online purification and product quality testing system to monitor titer, aggregation, charge variants, and post-translational modifications. When compared to traditional methods, the on-line system resulted in a >65% reduction in FTE resources and a 10x reduction in turnaround time. And they’re not the only ones! According to Kyle McHugh, Bristol-Myers Squibb has also set up an online method. Only this one is a FACs-based method that monitors cell viability and utilizes machine learning models to identify living, apoptotic, and dying cells in the bioreactor.
Takeaway No. 3: Impurity analysis is critical
There is a comprehensive need for impurity analysis at all stages of bioprocessing, not just when evaluating the final API. Vanessa Momaney at Avecia talked about the importance of controlling the purity and impurity profiles of nucleoside phosphoramidites (NPAs) that set sugar structure and nucleobase identity in therapeutic oligonucleotides and the steps taken to protect the NPAs during LC/MS analysis. Additionally, Meredith Packer at Moderna warned about the importance of monitoring lipid-driven impurities since they can lead to LNP-RNA adducts that negatively impact efficacy. And that’s just the beginning! There were several other discussions involving the need to analyze length impurities, earlier eluter impurities, modification impurities, and process impurities just to name a few!
Takeaway No. 4: No meeting is complete without some discussion about cell therapies
CAR-T therapies are gaining more and more traction as they continue to demonstrate great efficacy at treating late-stage cancers. Ho-Tak Lau from Bristol-Myers Squib discussed how the cell therapy field is leveraging mass spectrometry-based protein analysis tools to monitor upstream, downstream, and final product attributes. Several case studies were shared, including one for metabolomics. The REBEL cell culture analyzer was the platform of choice for targeted amino acid and metabolite monitoring because of the very short time required to run the assay and analyze the data, small sample volume needed, and the large number of attributes that could be monitored per assay.
Those are just some of our takeaways from Boston Biotech Week. Did you attend as well? What were your takeaways? Let us know at firstname.lastname@example.org.
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 devices that can help.