A Case Study to Highlight Capabilities to Quickly Produce Custom Products
The astonishing speed at which the SARS-CoV-2 virus spread across the globe triggered a demand for rapid development of diagnostics for mass population testing. Seeing this need, we at Teknova moved two novel formulations of viral transport medium from development to FDA notification, then to manufacturing at scale within 6 months in 2020—an achievement that is enabling greater access to COVID-19 testing worldwide. In this case study, Scientific Director Bella Neufeld, and Vice President of Engineering Jose Olague, discuss the development journey of Teknova Active Viral Transport Medium (ATM). They explain how its unique formulation addresses the challenges posed by mass testing and explore how they were able to develop and scale up production of this medium so quickly.
Early in the COVID-19 pandemic, production of the standard medium for viral sample collection—known as universal transport medium (UTM)—was disrupted, and the product became unavailable. This problem led the US Centers for Disease Control and Prevention (CDC) to release the formulation and manufacturing instructions for viral transport medium (VTM).
In April 2020, we used our experience as a custom reagent manufacturer to begin production of VTM, under the name Teknova Viral Transport Medium (Figure 1). It soon became clear, however, that there were some challenges with the CDC formulation, as Bella explains: “We got many phone calls and emails asking if the VTM had to be refrigerated. The need for the medium to be stored cold—even before vials have been inoculated—was a requirement that many healthcare providers couldn’t meet, and this affected testing capacity. Our team at Teknova had a crisis meeting, and in July 2020, decided we would develop a new formulation of VTM that could meet the challenges of widespread COVID-19 testing.”
Figure 1. Timeline for Development and Production of Sample Transport Medium.
Optimizing and Making the Medium
The team identified several characteristics of a sample transport medium that would improve the logistics and efficacy of testing during the pandemic. According to Bella: “We knew that the optimized medium had to be room-temperature stable, as this would eliminate the need for cold storage and transport. We also realized that there were issues with the use of fetal bovine serum (FBS)—a reagent with variable components that could include RNases, which have the potential to degrade the viral SARS-CoV-2 RNA before tests are run. This is why we chose bovine serum albumin (BSA) in place of FBS for ATM, as BSA is more chemically defined and eliminates the risk of sample degradation.”
After determining additional features for the formulation, the team started development of ATM, guided by their experience with custom reagent manufacturing. On this stage, Jose said: “One of the reasons we were able to develop this product so quickly was because we built a dedicated ATM clean room from scratch. Building to a design that was specific to ATM enabled us to streamline product development and ensured that minimal process changes were needed further down the line.”
Making ATM also required us to install new equipment and use entirely new analysis techniques—but using processes with which we had extensive experience. According to Bella: “We regularly implement new testing methods when manufacturing custom products, which definitely gave us a head start with the ATM. Our extensive QC measures are applied throughout the manufacturing process and knowing how to adapt these to new products helped us speed up development of ATM significantly.”
Rapid Scale Up of ATM to Meet Viral Testing Needs
To scale up production of ATM, we expanded our manufacturing capacity. New equipment , including automated lines for liquid handling, bottling, and capping, saved time and massively increased throughput. On this, Jose stated: “The automation has enabled a huge increase in ATM production capacity, from zero to 300,000 tubes per week at the end of 2020, and will reach a capacity of up to 1 million tubes per week by June 2021 with the addition of a new cleanroom. Automation also allows us to better control contamination risks, giving users added confidence in the sterility of the product.”
Having a robust supply chain is also critical to ensuring successful product development, especially during the COVID-19 pandemic. As Bella explains: “Because Teknova has been doing in-coming QC on raw materials for so many years, we have a wealth of data that enables us to rapidly switch vendors and purchase different materials that we know have the same level of quality. This makes us more flexible and enables us to manufacture consistently high-quality products without interruption.”
While cleanrooms, equipment, and QC have all played a role in the journey of ATM development and manufacturing at Teknova, Bella also attributes Teknova’s agile response, in large part, to the company ethos: “There is extremely strong communication between departments at every level, resulting in potential issues being dealt with very quickly. Our emphasis on GMP manufacturing and ISO 13485 processes promotes a company mindset that allows us to adapt to manufacturing different products with confidence and gives us the conviction that we can achieve anything.”
Looking to the Future
Teknova’s CEO, Stephen Gunstream, has big plans to expand production capacity, a vision shared by Jose: “We are really moving the company forward, introducing new technologies that not only enable us to make better products, but products that are also sensitive to contamination or changes in environment. The ability to quickly change our fill-finish manufacturing capabilities is really one of Teknova’s key strengths.”
On the direction of the company, Bella commented: “While we are sure to expand further, Stephen also understands the benefit of being a medium-sized company, and the edge that this can give in terms of flexibility—whether that be rapidly changing filling volumes and containers from milliliter to microliter level or adapting existing products to changing customer needs.”
While scale up of ATM is ongoing, the product now has FDA notification, and we are also filing a 510(k), which will extend availability of the medium beyond the COVID-19 pandemic. Products such as ATM highlight our ability to handle rapid product development and scale up for customers, bringing high-quality media and reagents to market when they are needed the most.
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