Pandemic demand drives skills and production gap

Solis BioDyne, a small and privately held company of 53 employees, manufactures PCR/qPCR reagents. These are used to analyze RNA and DNA from any living organism. One of their products — a ribonuclease inhibitor — is extensively used in an RT-qPCR test for COVID-19. Previously, the company manufactured this product at bench scale. However, to rapidly service the demand for COVID-19 tests, they needed to increase their production 50-fold. Fortunately, they had the space to boost their production, thanks to investments by Solis BioDyne in 2019 for facility expansion in Estonia.

Rising to meet the challenge

So, Solis BioDyne had the opportunity to move quickly and easily to avoid production delays. Their highly motivated and committed team took the patented technology, which is stable at room temperature, and quickly scaled-out their bench-scale process to meet demand. First, they tried to replicate their existing process many times.

Solis BioDyne’s production facility follows the quality standards for medical device manufacturing. As such, they had to adapt and try different strategies such as working in shifts, tripling their production team, and adding more people to the team overall. Training was imperative, as employees must follow existing work instruction documents and SOPs to maintain quality standards. Scaling out the existing process initially had several benefits in terms of timing and using existing manufacturing protocols. But it proved to be cumbersome and resource-intensive to achieve the production volume that was needed. The company was adapting quite quickly, but at the end realized that it must scale up instead of out.
Ramping up production was challenging, as the company’s production needs were variable before the pandemic. First and foremost, they had to keep employees safe and healthy in extraordinary times; they also faced two challenges – how to produce this large volume safely, and how to make sure the quality remained very high.

The solution – bridge the gaps

Solis BioDyne needed to rapidly learn how to manufacture at 50 L production scale, to help make their production much more flexible, cost-effective, and efficient. During a five-week stint at Testa Center in Uppsala, Sweden, they used a non-GMP manufacturing lab space to run experiments at scale while accessing a team of experts who helped them optimize their process with hands-on learning – and without compromising on yield and quality standards.

Priit Karjus, CEO of Solis BioDyne, says, “We are working with bacteria that you must feed and optimize, adjusting critical process parameters, instructions, etc. to get the best outcome. You may think when you are tripling or doubling volume to scale up, it should be the same conditions. But it is not. Living cells behave differently in new conditions, so you must adapt the system to get the same or better results.” And this was critical knowledge the team learned.

Angela Vaasa, COO, Solis BioDyne, says, “We were accustomed to managing our own production lines. But in February 2020, this became unrealistic in the face of increased needs due to the pandemic. We already use chromatography systems from Cytiva, so we asked for advice on how to scale up our production, and they recommended Testa Center.” While Angela admits, “The 50 L bioreactor scale seemed scary at first,” support at the Testa Center made this process far less daunting and helped the Solis BioDyne team learn to scale to the needs of their customers.

Priit adds, “Testa Center is kind of a fitting room. You could try on the venue and different equipment to see if it suits you. Such two-way compatibility is needed.” Cytiva and the Swedish government came together to bring Testa Center to life, to support small-scale startups and research groups that, for example, have a skills gap and lack the expertise or resources to scale up or try something different.
As is true for many smaller nations, Estonia’s life sciences industry is growing and focused on recruiting key talent into the region. But this is easier said than done, as many such workers in Estonia are already working with large global pharma companies. This skills gap can slow the progress and commercialization of molecules in development. The consequence of having unskilled workers can also be detrimental to the company’s bottom line and regulatory approval.

Long-term, Estonian companies are aiming to attract this talent to local companies, in a country known for digital innovation, biotechnology, and related expertise, and recognized by the European Space Agency[1]. Until then, institutions like the Testa Center will be pivotal in supporting innovative, emerging companies like the ones in this region — by providing the appropriate talent as well as advanced and routine training programs — so they can execute both process development and manufacturing operations.
As Priit says, “It is important to have cooperation between different countries especially in pandemic situations. We needed really high quality and real expertise in process details, with quality-driven procedures — even during a crisis period — because you must do things the right way. If we are connected, then we all do well.”

About Testa Center

Testa Center offers businesses and academia globally a modern, pilot-scale testbed for projects and education in production of biological products e.g. monoclonal antibodies, peptides, protein, vaccine and viral vectors (non-GMP, up to Biosafety level 2 and 500 L). In the flexible facility, and with support from experienced staff, you can perform a wide variety of projects, including scale-up of parts of a process, or a complete process from frozen cell bank vial to purified protein. Testa Center is a public-private partnership between Cytiva and the Swedish government.

About Solis BioDyne

Solis BioDyne provides and manufactures molecular biology solutions to help scientists in solving their greatest challenges. DNA polymerases, PCR Master Mixes, qPCR Mixes and reverse transcription reagents are highly valued across the globe. Solis BioDyne uses unique genetic modification within all products to make them stable at room temperature for 30 days, to provide more sustainable and cost-effective solutions.

About Cytiva

Cytiva is a global life sciences leader with more than 8,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture, and delivery of transformative medicines to patients.

References
[1]?https://www.workinestonia.com/living-in-estonia/science-technology/. Accessed May 14, 2021.!

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