Ology Bioservices is a full-service Contract Development Manufacturing Organization (CDMO) serving both government and commercial clients, specializing in biologic drug substance manufacturing from early-stage through commercial product. The company is continuously evaluating new technologies to be on the cutting edge of the newest offerings for their customers. In this aim, Ology Bioservices has acquired our scale-X™ fixed-bed bioreactor and Dalton Berrie, Process Engineer, has conducted the technology evaluation tests.
Welcome Dalton! Explain to us your responsibilities within Ology Bioservices? On what occasion were you brought to use Univercells Technologies’ scale-X fixed-bed bioreactor?
I am a Process Engineer specialized in Upstream Process Development of live virus vaccines, bacterial production of recombinant proteins, and gene therapy vectors. I lead teams of scientists and engineers to produce robust scalable processes with a focus on product yield and safety.
Lastly, I serve as a bridge between PD, Tech Transfer, as well as Engineering Services. This includes the evaluation of cutting-edge technologies in order to improve cycle timing and processes to decrease the cost of goods and increase yields. In this objective, I was brought to make several bioprocessing runs with the scale-X carbo bioreactor to demonstrate equivalent or higher yield to other traditional systems.
What challenges are you experiencing in vaccines manufacturing?
One of the biggest challenges in vaccine manufacturing is scalability. When using flat-stock or cell factories, the main experienced challenge is the ecological footprint. Once we evolve towards suspension systems, such as large stirred tank reactors and adherent cell cultures, we do experience issues with scalability. The question we were trying to answer is can we have a smaller ecological footprint in order to be more environmentally friendly, decrease manpower and COGs while maintaining or increasing our product yield?
The Ology Veroplex® platform performed very well with the scale-X carbo system. Its flexibility enables to leverage our acquired experience with the Veroplex platform and use additional cell types to generate new products.Dalton Berrie, Process Engineer – Ology Bioservices
How did the scale-X bioreactor range answer to your needs and what features did you particularly like about this technology?
The scale-X fixed-bed bioreactor checked all the boxes to tackle the challenges experienced above. The flexibility of the technology and its small footprint is particularly useful for fast and easy deployment of pop-up labs for a rapid response situation. The system is very user-friendly, and the user interface is straightforward and can be understood by any person and clearly display any problem. The system has demonstrated reliability throughout runs.
Overall robustness is for us a very important feature. Indeed, we are searching for technologies that can be used for manufacturing material that will be used into people. In these cases, process controls and understanding critical attributes are essential. In the process development setting that we are, we feel confident in the ability to transfer the scale-X technology to manufacturing with a process that has controls in place.
What is your experience with Univercells Technologies customer relationship?
Our relationship with Univercells Technologies is fantastic with continuous communication. Whenever we have a run going on or production campaign, I feel supported and I’m not worried about any lack of performance.
What outputs and new perspectives did the collaboration with Univercells Technologies brought to your company?
The Ology Veroplex® platform performed very well with the scale-X carbo system and we can project to expand our viral vaccines and vectors production. Thanks to the flexibility of the scale-X carbo system we can leverage our acquired experience with the Veroplex platform and use additional cell types to generate new products.
The collaboration with Univercells Technologies has open the door to produce large batches of material with reduced costs and low-footprint. It leads us towards continuous process improvement and gives us the opportunity to become leaner as an organization. We could rapidly respond to the needs of the community, to warfighters, and evolve towards global response, such as for COVID-19.