The Director of BARDA, the US Biomedical Advanced Research and Development Authority, told the annual meeting of the American Association of Pharmaceutical Scientists this week that despite GSK plans to massively escalate production of its cAd3 EBOV vaccine candidate to millions of doses by next year, the company will not turn to a CMO.
Scale-up to commercial capacity is a daunting task for all companies producing Ebola vaccine candidates, as they try to truncate a process that normally takes two years to a projected nine to twelve months.
Added to the usual efficacy and safety hurdles, drugmakers must also deal with the simple problem of how to free up desperately-needed manufacturing capacity to reach production quotas.
For its primate studies, GSK worked with the research centre at its daughter company Okairos to produce its Ebola vaccine candidate in runs of tens of thousands of doses.
But now the company is thinking in terms of millions.
“GSK made a decision to move their resources and people to take it in-house,” said BARDA’s Director Robin Robinson, whose organisation is working closely with the company.
“They reassigned their very best vaccine people – from upstream processing, downstream processing, formulation, lyophilisation, and clinical, to focus on this problem.”
The company decided to move its large-scale Ebola vaccine production to its Rixensart facility, vaccine base in Belgium. The decision obviated the need to waste resources performing tech transfer to an outsourcing partner, said Robinson.
But not all vaccine makers have GSK’s capabilities – Newlink Genetics has turned to a German CMO to scale up its rVSVΔG EBOV candidate, and is “also looking at an American manufacturer,” according to Robinson.
So the resources needed to make millions of doses are being brought to bear already but it’s not an overnight process.
BARDA is funding process scale-up for the four most advanced Ebola vaccine makers – GSK, Newlink, J&J, and Profectus.
In documents leaked two weeks ago, GSK expressed concern about the “critical issue” of fill capacity and suggested regulators allow it to make cAd3 EBOV under Biosafety Level 1, instead of more stringent Level 2 conditions.