Manufacturing proteins to support turning cells into any organ of the human body may seem like a movie scene, but BioLamina, a flourishing Swedish company makes it seem more real. Dedication, knowledge and the right environment are the necessary tools to achieve the goal of scaling up and growth. With that in mind, the team from BioLamina entered Testa Center.
The team from BioLamina came out acquiring a new educational level in bioprocessing, do-it-yourself and hands-on experience and increased overall value. One thing they haven’t anticipated is that they will even figure out how to design their own laboratory. They packed their equipment ready to leave, very happy with the outcome of their work at Testa.
“We came to Testa center with a 10 Liters scale process already developed to manufacture our product MX/CTG Laminin 521. We aimed to scale up the process to 40 L. Now we have designed a process that allows us to produce and process 40 Liters of harvest multiple times in a month, if necessary”, explains Parinith Sudhakar, an upstream scientist from BioLamina, who spent several months testing and scaling up at the facility.
Testa has passed the test
The future is bright for BioLamina and the next steps for the team is to validate the developed process in house at their own facility, to prepare them for commercial productions.
“The results that we have gotten from Testa make way to consider scaling the process even further for e.g. to 200 L scale. Besides, we have many more isoforms of Laminins that are in the pipeline; the experience and results add to our strengths to execute our future projects. I don’t exclude the possibility to come back to Testa Center in the future” adds Parinith.
Increasing sales and customer demand had put Biolamina in a situation where production processes needed up-scaling in a quite short time frame. therefore, it has been of paramount importance to be fast and efficient, and Testa has passed the test. Essential, according to BioLamina was the competence of the Testa team. Availability of competence was a key success factor in order to keep the tight timelines. Also, acquainting new skills and getting familiar with new equipment fast, was crucial to them.
“Cytiva is one of the best in bio processing business. Learning from here are great. There were many materials and consumables that we didn’t have knowledge of and the staff at Testa helped us in choosing and ordering the right materials that go into our application beforehand. This saved us a lot of time and we could focus more on the process”.Parinith Sudhakar, Upstream Specialist at BioLamina
Upstream and downstream
Testa Center: Can you describe the upstream process at Testa Center?
Parinith Sudhakar: In upstream, for one of the unit operations in our scale-up design, we used Ready to Process Wave 25, that we got from Testa center. It was an excellent choice since we could run many small-scale studies to determine optimal operating settings before doing an actual scale-up. This unit operation simplified our scale-up process.
TC: Was the team from Testa Center helpful?
PS: Even before I did these small-scale studies, I had taken up a few technical discussions with the upstream specialist at Testa center and a Cytiva sales member to evaluate the feasibility of the idea. Also, some suggestions from their experience made us rule out certain types of materials/options which could contribute to poor process design. The discussions were very useful to go ahead with more confidence. This wouldn’t have been possible if we were to make these decisions by ourselves.
TC: Did you get help for the downstream process?
PS: The same thing applies to the downstream process. The downstream specialist at Testa had arranged a meeting between us and other experts from the Cytiva campus. This was even before we started to execute our plan. Hearing comments on our ideas from many experts reaffirmed our confidence.
Testa has provided the essential instrument and consumables:
- XDM-50 and -100 mixer for loading preparation
- 3D bags
- ÄKTA pilot 600
- BPG100/500 column