The Johnson & Johnson unit was perhaps the highest profile firm affected by the quality failures at contract manufacturer Ben Venue Laboratories which culminated in a US Food and Drug Administration (FDA) consent decree and a decision by owners Boehringer Ingelheim to close the Bedford, Ohio site at the end of last year.
Janssen had previously suffered shortages of its ovarian cancer drug Doxil after relying on the CMO as its sole supplier, and therefore took over the site earlier this year for a six month tenure to continue manufacturing under authorisation from the US District Court of Northern Ohio and the FDA.
With the lease will soon run out – and the facility’s future up in the air following Hikma’s exclusive right to buy the Ben Venue assets as part of its acquisition of parent firm Bedford Labs last week – we spoke with Kyran Johnson, General Manager of supply chain in Ireland, to see how Janssen’s outsourcing strategy had moved on.
“There is certainly a perspective that if you go to outsourcing manufacturing, you lose control over it and you’ve got companies that maybe don’t have the same standards as yourself, but I think that’s changing,” he told Outsourcing-Pharma.com.
“I think that J&J more than perhaps any other company realise that we’re responsible for the products and the supply to the market, whether we manufacture ourselves or whether we manufacture through a third party.”
Johnson said that Janssen needs to ensure that the CMOs it works with can demonstrate they have the same capability, technically and in compliance with cGMP, as at its internal sites, adding that the company is looking to ensure it “has a robust process in terms of our external suppliers, and make sure we have the systems in place to assess and support, and make sure they can meet those requirements.”
Though not directly involved with the Ben Venue saga Johnson told us it “has been a real problem and a real issue for the company as to how we can sort that out,” whilst confirming a new supplier is currently coming on line.
In-house Complexity
Whilst J&J’s outsourcing strategy depends on a number of variables and is both product and platform dependent, Johnson said the firm still did a “significant amount of outsourcing of manufacturing of small molecule because the capacity is there.”
However, for biologics and more complex production techniques, Janssen would be more likely to invest in its own capabilities due to the level of technology and experience not being available from third-parties.
“You look at the product you’re going to make, the technology involved, the value of it and then you are assessing if this is a technology we need to build in-house expertise, or is it well-established out there,” he expalined, adding Janssen – like other Big Pharma – is limited by its capital expenditure.
“Are you going to put that into your high value more complex technology pieces, rather than taking something that’s being produced using certain technologies that’s been there for many years? It’s a lot less risk to do that.”
Fellow Big Pharma firm Eli Lilly told this publication recently it was taking greater control of its in-house production as manufacturing becomes more complex.