The specialist CMO started validation work on a new 1,000L HyClone bioreactor at its biopharmaceutical manufacturing facility in Södertälje, Sweden last week with the aim of completing the process by March next year. BioPharma-Reporter.com visited the facility on last Wednesday where site manager Ulrike Ljungkvist said the desire to shorten production lead times drove the decision to choose the Thermo Fisher system.
“The lead times are a huge challenge in this kind of [biopharmaceutical] production” according to Ljungkvist, who contrasted them with her background in small molecule drug production at Cobra’s neighbour and former owner of the Södertälje facility, AstraZeneca.
“In small scale API production you can perform one chemical step in a day and run a whole campaign in a week. Here [at the biomanufacturing site] from thawing the cells, it takes ten weeks to produce a single batch of API.”
Efforts to reduce these timelines were an important part of Cobra’s choice of commercial-scale bioreactor Ljungkvist continued.
She explained that a desire to apply development-stage data during scale up was “the main reason we chose the HyClone Sub for 1,000L is because that is what we have for 250L development and 250 GMP.”
Another of Cobra’s strategies is to work with technology suppliers to guide the development of improved production systems.
“We do have very close interaction with our suppliers and the purchase of materials is done by the teams that use them” Ljungkvist said, citing downstream filters, culture bags and connectors as areas of close collaboration.
This was echoed by CEO Peter Coleman who told us Cobra – which uses a the Ambr mini bioreactor by Tap Biosystems for mammalian cell based development- is testing a similar technology for microbial protein production in collaboration with a second supplier.
“We will be the test pilot for the system…we get to familiarise ourselves with the equipment and the supplier gets some good feedback from the scientists who know what they are doing with that equipment.”
As a side note - both Coleman and Ljungkvist said that they do expect Tap Biosystems’ acquisition by Sartorius Stedium to impact the contract manufacturing organisation’s (CMOs) close collaboration with the suppler.