Kevin Kayser, head of R&D at SAFC, told BioPharma-Reporter.com the viral safety of raw materials is “an area that’s really hot right now.”
He said the company is working to prevent the propagation of viruses that can affect mammalian cell lines as well as human pathogens, as opposed to the issue of viral clearance, which tackles the viruses later in the manufacturing process which can affect humans.
Kayser told this publication the company had attained proof-of-principle on virus-resistant lines, but still had validation work to complete.
“We don’t know what the end product looks like yet but we’ve certain manipulations within the cell that provide viral resistance. We’ve created some targets. The trick will ultimately be [showing] that you can confer in the CHO [Chinese hamster ovary] cell lines, but you can’t change anything else [such as] sugars.”
‘Two-pronged’ attack
Commonly, viruses can enter cell culture raw materials from mice droppings in warehouses. One particle that becomes incorporated can be reproduced as cell lines grow until they prove damaging or fatal for the cells.
Prevention should be a “two-pronged process,” Kayser said, both screening raw materials to prevent contamination, and as a second line of defence, creating cell lines that will not propagate a virus if it reaches the bioreactor; “it’s a fairly rare event, but it’s an insurance policy.”
Alison Armstrong, a senior director within Development Services at BioReliance told an SAFC symposium on biopharmaceutical supply chain vulnerability last week that viral risk “causes an enormous amount of impact to industry.”
Cell loss due to pathogens can slow manufacturing and impact the availability of medicines to patients, she said, “especially with life threatening diseases – this can have a direct effect on materials or products, which are [sometimes] produced by sole source providers.”
Armstrong also pointed out that, aside from cell death, the stress of infections can affect the quality of cells and “have a direct impact on post-translation modification.”
She added that viral contamination brings additional risks to other products in the same facility, a situation BioReliance has been “directly impacted by.”