Mitigating Risk in Scale-Up

A lab-scale process does not always successfully translate to production scale, and this potential failure can be a costly risk in the biopharmaceutical field. To mitigate this risk, an initiative was launched in Sweden in 2018 to provide access to equipment and expertise in bioprocess scale-up—the Testa Center. To find out more about this initiative, Pharmaceutical Technology spoke with the center’s director, Jesper Hedberg.

Accelerating innovation

PharmTech: What is the mission of Testa Center and how was it conceived?

Hedberg (Testa Center): Our vision is that together we accelerate the journey of world changing innovations. We do this by making our production-like facilities available to researchers for verification of innovations and scalability experiments.

Testa Center is a private-public partnership, making the facility available for the life science community at large. The center is a joint effort between the Swedish government and Cytiva, and its main objective is to promote growth of the life science sector and bridge the gap between discovery and industrialization.

Testa Center is owned and operated as a non-profit company by Cytiva in Uppsala, Sweden. Since its inauguration in September 2018, more than 30 projects have been performed by clients in the center.

Services on offer

PharmTech: What services are offered at the Testa Center?

Hedberg (Testa Center): Testa Center is an open access, non-good manufacturing practice (non-GMP) production-like environment/facility and testbed for education, innovation, and proof-of-concept experiments around production of biological products (e.g., monoclonal antibodies, peptides, and proteins as well as cell and gene therapy products).

In the Testa Center, researchers have access to both equipment and expertise to drive their biological production process from lab bench scale to industrial pilot scale. The offering includes access to expertise, labs, and equipment for scaling up. Projects typically come with aims such as showing scalability or manufacturability or generation of larger amounts of material.

For cell culturing, Testa Center offers bioreactors from 1–500 L. For harvest, the center has instrumentation for filtration as well as batch and continuous centrifugation. For protein purification, instrumentation from lab bench scale all the way up to pilot- and full-scale production, including a variety of column sizes, are available. The complete instrumentation list can be downloaded from the website.

PharmTech: Are there any capabilities/services that are not yet available at the Testa Center that may be added in the future?

Hedberg (Testa Center): We have just recently commissioned a BioSafety Lab class 2 in Testa Center available for vaccine and cell therapy applications. Also, we are in the middle of commissioning a larger bioreactor (200 L) for microbial purposes. This new bioreactor will be available for clients in Q2 2021.

In addition, at the end of 2020, we launched an activity in the center inspired from open innovation and hackathon events—the Testa Challenge. This was an effort to make Testa Center capabilities available to a larger extent for technical and digital projects and at the same time test out a new way of verifying innovations in the bioprocessing space.

Reducing risks

PharmTech: How might bio/pharma companies (both those from Sweden and globally) benefit from using the Testa Center?

Hedberg (Testa Center): Taking an innovation from bench scale to industrial scale is accompanied with a lot of risks. In Testa Center, start-ups and research groups have the possibility to reduce technical risks when going up in scale and thereby increasing the chances of surviving the phase when going from a successful proof of concept in lab scale to production.

Also, as projects and companies have access to the expertise inside Testa Center, it is possible to have consultations during the experiment design and execution phases, which allows for quick iterations in experimental design and to adjust and pivot when needed.

Pandemic impact

PharmTech: Has the pandemic created particular challenges or opportunities for the Testa Center?

Hedberg (Testa Center): The pre-pandemic plan was to make 2020 the year of European outreach. This plan did not come to fruition, and the Testa Center had to, during 2020, focus on the Swedish and Nordic regions.

Now, during 2021, we are running a project, ‘Testa Center Outreach’, together with Business Sweden and STUNS to reach out to the wider European market. Naturally, we need to follow the pandemic carefully as running a project in Testa Center very often requires travel. Projects have the possibility to engage local contractors for project execution, and we are actively working to expand this offering.

Additionally, we have had several requests for projects related to the fight against COVID-19. One of these projects has just finalized their execution phase in Testa Center. At this point, we cannot share more info due to confidentiality, but we will shortly share more around these activities in our channels.

Future aim

PharmTech: What is the main vision for the Testa Center in the next 10 years?

Hedberg (Testa Center): The overarching aim is to support the life science space and to enable researchers to take the leap into commercialization. The vision is (as stated above) that in 10 years’ time from now the journey of innovation is accelerated and completely changed. To elaborate a bit further, the new natural will be to build value and competence in organizations in a completely different way.

New drugs and new molecules (sometimes referred to ‘the new Zoo’) are being discovered at an increasingly higher pace and the complexity of molecules and modes of actions are also getting more complex. To answer to these challenges, we need to be better, faster, and more efficient. Biological production is an intricate part of bringing new drugs to patients, and Testa Center is here to support researchers to succeed in their efforts to establish scalable production processes.

About the Author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.