Piles of print and plenteous discussions have been dedicated to the virtual audit for CDMOs since the onset of the coronavirus pandemic.
I contributed to the cornucopia around Thanksgiving last year, with an editorial in Life Science Leader magazine, which I now recognize as a preemption of sorts to a recent article published here in Outsourced Pharma, titled: “CDMO Selection: Can We Eliminate The On-Site Audit?”
Here’s a slightly edited version of that earlier treatment of the value proposition of our continuing virtual state of outsourcing affairs.
Greg Birrer is Quality Head at Elusys Therapeutics, a private company focused on antibody therapeutics for infectious disease, with a BARDA (Biomedical Advanced Research and Development Authority)-sponsored commercial drug for anthrax (ANTHIM; obiltoxaximab)
His thoughts on a virtual state of outsourcing originates from surveying his decades of working with external partners.
“I was at Roche when it acquired Syntex, a biotech with some really good products,” he recalls.
“At the time [late 1990s], Roche in Nutley, NJ, made all of its products internally. We had no capacity to deal with Syntex’s products being manufactured around the country. It was still early for outsourcing at big organizations, but we quickly realized what was most important: doing our best to vet and then communicate effectively with all the CDMOs.
“Of course we performed qualification audits. Those are always tough to accomplish.”
Tough because, says Birrer, even when on site, CDMOs are always going to find a way to show you their best side.
Effective audits have now become even trickier. For quality professionals like Birrer, the coronavirus cramped a certain way of life that included personal-touch relationships to keep projects humming at external partners.
A few months into the outbreak in 2020, Elusys conducted “a bit of a low complexity and low criticality audit,” to test the technology waters, via a virtual walk-through of a CDMO facility.
“And it’s just not the same,” Birrer says despondently. “I like to go to the facility and see the people.
Then with a wry laugh: “Are they walking around with their heads hanging down? Are they moping? Why isn’t anybody laughing in the lunchroom?”
“I’m in quality, sure, but you can tell a lot about a company by how its employees are behaving. What’s the morale level? You can’t get that from a virtual tour.”
“More fundamentally, I can’t suddenly decide to pull a chemical off a lab shelf and read the expiration date. During on-site audits I’ll often go off my agenda if I see things to look into. That’s when you learn a lot. So, I think it’s suboptimal at best having to do virtual audits right now. What are you getting out of them, really?”
Perhaps this needed to be clearly enunciated.
From where I sit as chief editor, I’ve seen the brave faces and heard the reassuring voices throughout last year.
“We’re holding up very well during this pandemic,” outsourcers of all stripes say.
But I also detect a circumstantial fear playing in the background:
How long can we keep this up? Can we make the right decisions in selecting and managing our CDMOs with such limited physical interaction?
“So you do the best you can. In our case, we fill our drug product on the West Coast [Elusys is located in New Jersey], and usually send a person to the plant. But we didn’t go when they made the last batches. We watched remotely. There’s only so much you can get; the camera can be grainy, it doesn’t cover the room…”
The take-home message to our readers heading into a second year of engaging in outsourcing during this pandemic: You are not alone in your “it is what it is” attitude, and at the same time, those continuing concerns you harbor.
The main advice from Birrer?
“Keep the attention level on your projects as high as possible throughout 2021.”
Do I Have Your Attention?
Today’s external labs and plants are filling up with highly potent, high-value, small-volume products, precision and narrow-market medicines, cell-and-gene therapies, and other new areas in our industry.
Both drug sponsors and CDMOs are thus faced with “sporadic campaigns” — relatively small amounts of drug product manufactured once and not again until after long gaps when more material is needed.
This can result in a “Groundhog Day scenario,” says Birrer, “where CDMO manufacturing teams are constantly relearning how to manufacture your product. It can lead to higher deviation levels.”
One (perhaps surprising) remedial activity is introducing “an iteration of batch-record tweaks, mostly adding detail,” Birrer says.
“Revising the batch record ahead of a new campaign – so people at the CDMO are familiarizing themselves – is helpful. The point is you want to gain renewed attention to your product.
“In the past, you could go to the CDMO, and in our case, treat the sterile operators to a lunch. I can talk to them about critical steps in the process, the need for rapid in-process sample processing, and about how important our anthrax product really is: ‘If there were an anthrax attack, our government will use this to help protect our citizens.’
“That narrative cements in the minds of external partners. You’re talking about the product as friends. I want them to value our company, in the sense that if challenges occur, it isn’t ‘Oh, well … ,’ it’s more like ‘Wow, we let Greg down, let’s get this righted.’”
Yes, video audits and conferencing, as limiting as we’ve described above, does allow for this type of attention-grabbing “narrative building.”
If sponsors work at it.
A virtual medium can help keep relationships fresh. And that, perhaps as much as anything else, is the continuing challenge of 2021.
Outsourcing still runs on relationships. Like Birrer, put your best foot forward, but always recall what was most important pre-pandemic to guide your progress.