The Gothenburg based, Swedish biotech company Toleranzia AB entered Testa Center building in Uppsala with packages full of materials and hope. Their entrance represents an important national breakthrough for and an opportunity for Toleranzia to validate the manufacturing process for the drug candidate TOL2 and to provide further industrialization of the company itself.
”I think that there is no other alternative than Testa Center in the Nordics for validation process at this stage of development”.
”I have learned a lot. Every step of the process, setting up the columns at a much larger scale is a whole new method. It’s a really good experience, lots of help and fantastic equipment. The team is very kind, helping us with the technical and practical needs”.
Jan-Olof Andersson, responsible for the protein-chemistry operations at Toleranzia
Testing Scalability
Toleranzia develops bio-pharmaceticals that utilize the immune system’s own intrinsic power to treat orphan autoimmune diseases. These drugs target the cause of the disease to cure or greatly alleviate the disorder, unlike currently available treatments that only reduce the symptoms. The company’s drug candidate, TOL2, is being developed for the autoimmune nerve and muscle disease myasthenia gravis. As a step in the endeavor to bring the drug candidate to clinical trials, Toleranzia decided to test the team and the state-of-the-art equipment at Testa Center. The team of scientists hoped to be able to validate the manufacturing process on a larger industrial scale for TOL2. And the project turned out to be a success!
Testa Center as a bridge
”We have reached our goal to scale up the process for TOL2. We have achieved that at Testa Center”, explains Jan-Olof Andersson, responsible for the protein-chemistry operations, including the development of both lab-scale and large-scale protein production processes for pre-clinical and clinical studies. According to Jan-Olof, the process at Testa Center ran very smoothly and the team was able to scale up the process 40 times. Jan-Olof believes that access to the Testa Center with its unique instrument park was crucial for achieving this goal,” I think that there is no other alternative than Testa Center in the Nordics for validation process at this stage of development”.
Testa Center aims to do exactly that: Bridge the so-called Valley of Death between small scale and GMP ready production. Testa Center provides possibilities to lower the technical risks and can provide support to guide the companies over that bridge.
Teamwork, new skills and time saved!
Although Jan-Olof has extensive experience working within the biotech and pharmaceutical industry, within AstraZeneca, Arexis, and Biovitrum, for example, he states that he has gained new skills and knowledge at Testa Center.
“Yes, I think I have learned a lot. Every step of the process, setting up the columns at a much larger scale is a whole new method. It’s a really good experience, lots of help and fantastic equipment. The team is very kind, helping us with the technical and practical needs”.
As well as the newly acquired knowledge, he emphasizes the importance of time saved: “It would have taken so much time to use our lab in Gothenburg. We have made large savings” he says, before hurrying off to prepare the tools for the next step in the process, analysis of the purified materials.
Collaboration made possible
Toleranzia AB received 400 000 SEK from SWElife earlier this year for the project in Testa Center. “Testa Center has extensive expertise in biological medicine and a state-of-the-art advanced infrastructure for manufacturing on an industrial scale. We are very happy to have been selected to receive financing from SWElife, which is an important recognition of the TOL2 project. Now, in collaboration with Testa Center, we can validate the manufacturing process for TOL2 and produce TOL2 for the important formulation work” said Toleranzia’s CEO Charlotte Fribert in the company’s press release.
