Bioprocessing Must Evolve to Meet Global Demands for Speed, Affordability, and Access

The recent award of a development grant by CEPI marks an important milestone for Alveo and opens a deeper conversation about how bioprocessing must evolve to meet global demands for speed, affordability, and access.

Alveo Advisor Kat Kozyrytska sat down with us to share her perspective on the evolving landscape of bioprocessing technologies. The discussion explores how new approaches to quality control, workforce training, and digital workflows can enable more resilient and scalable bioprocessing models across vaccines and bioprocessing more broadly.

Where do current in-process and QC testing workflows create bottlenecks for bioprocessing teams?

The challenges are threefold:

• Many testing technologies are complex. These tests offer analytical depth that is extremely helpful in R&D and early process development, but as the process matures, the questions the tests are tasked with answering can be simplified from quantitative to binary readouts. In-depth analytical technologies can still be deployed to investigate events. But when routine first-line monitoring remains complex, decision speed slows, and costs rise.
• Complex testing often requires advanced operator training, which includes sample handling, instrument operation, analysis, interpretation, and documentation. All of this makes manufacturing facilities harder to staff and increases costs.
• With advancements in digitization and AI in manufacturing, manufacturing data, including testing readouts, needs to be captured and integrated in real time into the broader cross-lab, cross-site manufacturing execution and quality management systems to enable remote monitoring and decision-making. The more paper-based, local, or slow the data, the harder – and more expensive – for the facility to reach its full operational potential.

What do you believe differentiates Alveo’s platform in addressing these challenges?

Alveo’s platform is actually a constellation of technologies, all of which align with where the market and the technology are headed. The test itself leverages advanced assay chemistry, which makes it possible to put the assay in a handheld device. This form factor, in turn, makes the test easy to use and reduces analytical complexity. Together, these two technologies can help reduce costs and equip less specialized operators to run the test. The third layer is digital connectivity and analytics. Alveo combines geotagging and timestamping with centralized data analysis, which can support the cross-site visibility that the field is moving toward.

In addition, Alveo is a 13485 ISO certified device manufacturer with other tests already on the market. This means the manufacturing of the test itself adheres to stringent regulatory standards, with already proven reliability and scalability. This combination can offer bioprocessing teams both innovative tests and consistent quality supply, which is very important when deploying new technology.

How does CEPI’s support help accelerate vaccine manufacturing?

The award of the CEPI grant is significant because it aligns Alveo’s platform capabilities with bioprocessing QC needs for faster, more cost-effective, and more deployable testing. This grant accelerates Alveo’s development of vaccine testing technology to bring cost-effective in-process and QC testing to vaccine developers.

In terms of digitization, although we may think of cross-site visibility as a capability for state-of-the-art manufacturing facilities, this capability can be really helpful in LMICs for quality monitoring, cross-site standardization, and collaborative cross-site learning to accelerate process development and improve manufacturing efficiency.

Where do you see rapid, digitally connected testing having the greatest impact in manufacturing and QC environments?

If there is contamination, you’d rather know right away. When test results take a long time to arrive, the decision about what should happen to the run/batch is also delayed, impacting release schedule, capacity, and planning. A rapid point-of-use test built to be operator-friendly can help enable faster – as well as more frequent – testing during the process.

More broadly, digitization and AI are making cross-site monitoring and analysis increasingly important. Large pharma is moving toward visibility across sites, assets, and quality events. In this setting, a test that instantly uploads data for centralized analysis can improve traceability, auditability, and pattern detection across manufacturing processes and sites.

How do you see this type of technology extending into broader QC use cases across industries?

Alveo’s platform is broadly applicable, and the company already has a presence in animal health testing and bioprocessing. The unique value is in the combination of elegant assay chemistry, a simple handheld format and workflow, and digital connectivity. This positions Alveo to offer a connected testing system that can support detection, traceability, and investigation of contamination and impurities.

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Kat is a strategy and commercialization leader focused on translating market shifts into business action for health and life science technologies and AI-enabled platforms. Her work sits at the intersection of portfolio and market strategy, with a focus on turning scientific capabilities into products, applications, and partnerships. She helps companies identify opportunities, prioritize use cases, and build scalable commercial growth.

Kat brings experience across complex workflows in biologics, vaccines, cell and gene therapy, bioprocessing, analytical technologies, and digital platforms. She focuses on how AI is changing the technology landscape, capability ownership, and market adoption of innovation. Earlier in her career, she held growth, strategy, and portfolio leadership roles at Sartorius and Thermo Fisher Scientific. She trained in science at MIT and Stanford.

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