DISPATCHES FROM CPhI
Cobra Biologics looks to reduce volume waste during fill/finish
On what was described as a “very busy” first full day at this year’s CPhI in Frankfurt, Germany, Dr. Sharon Brownlow, Business Manager at Cobra Biologics spoke to Biopharma-Reporter.com about the company’s development in decreasing the loss of biologics during the fill/finish process.
“We understand the importance of people with biologics having small volume, very potent molecules, and losing any kind of volume of those is critical to them,” she told us. Therefore “we’ve spent a lot of time minimising the hold-up volume and losses in our fill/finish facility.”
According to the company, a ten-fold decrease in product waste has been achieved in the fill process by careful mapping of procedures and implementing changes in the working procedures and the choice of disposable fluid flow paths.
Other contract manufacturing organisations (CMOs) have similar ideas and equipment to Cobra, Brownlow said, but Cobra remains unique as the product contact part of its Matfors, Sweden, fill-finish facility – acquired as part of the takeover of Unitech Pharma Group in 2011 - is fully disposable.
“This means that you can minimise any cleaning validation issues. Because most fill/finish facilities are looking at filling small molecule APIs and not dedicated to biologics, having a fill/finish facility dedicated mainly to biologics means that we can spend a lot of time optimising it for these [products].”
The CMO also has a small scale GMP DNA and microbial production facility in Keele, UK, as well as another facility in Sweden, dedicated to mammalian proteins and monoclonal antibodies manufacture.
Moving to Prefilled
Regarding changes in the industry, “one thing that’s happening more is people are moving to pre-filled syringes,” even for clinical trial material, Brownlow told us, due to prefilled syringes becoming more economical in price.
“We have a fill/finish line that does both vials and prefilled syringes, and the economies of using prefilled syringes is now a very similar price. This makes it very simple for the clinician to administer and takes away a lot of operator error and a lot of risk in the process.”
