By Louis Garguilo, Chief Editor, Outsourced Pharma
Joseph Graskemper, ruminating on the “early days” of his still young career – a decade of outsourcing development and manufacturing at organizations such as Alkermes, Biogen, and now Translate Bio, is saying:
“… I had to establish a CDMO vendor network based on the needs of our CMC team. This included a road trip around the U.S., stopping in at as many CDMOs as we could that might be a good fit for us.”
Those were the days, my friends. We thought they’d never end ...
But now, I ask, how would “Joe of 2020” establish that network, and at this point, manage those relationships and projects underway at CDMOs?
“It's tough, right?” he says through a sigh.
“A lot of those CDMO visits, you're not just looking at manufacturing equipment, you're searching for a cultural fit … Can I work with these people? But with that interaction curtailed, some of the decision-making becomes a shot in the dark.”
“So,” Graskemper continues, “you’ve got to meet via video with the CDMO leadership team, as well as those who will work directly on your projects.” This, he says, is a key requirement on the relationship path.
Graskemper also extols the virtues of virtual tours.
And, he was “involved in a process to actually create a virtual PIP [person-in-plant] experience. It turned out to be something that should carry on post-COVID-19.”
And all you need is an iPad, IV stand, and some collaborative ingenuity.
Outsourced Pharma readers may have heard of similar solutions. CDMO personnel roaming their labs and plants taking video via mobile devices, in an effort to bring the insides of their facilities to a drug-owner banished to the outside.
But Graskemper’s creative – and highly cooperative – process between CDMO and biopharma customer is a particularly informative case study.
As readers know, some modalities today have novel processes all but requiring a PIP from the sponsor company to help ensure things go well.
“Or maybe it's simply a crucial element of the timeline,” Graskemper says. “There are factors that dictate you absolutely need to have a person there.”
“We were in that situation when the coronavirus hit. I’m proud to say we put our heads together with our partner to figure out what was possible, what could we create.”
Graskemper started out acknowledging “a general hesitancy around putting cameras or video in manufacturing suites at CDMOs.” But the coronavirus had ushered in a new openness.
In this case, service provider and sponsor mutually agreed the goal was to get personnel from the CDMO to somehow relay to the customer what was transpiring as processes were taking place. They settled on an iPad as a live-shoot vehicle.
“I didn’t know if it was going to work,” admits Graskemper. “And it didn't.”
“It was hard to follow; you actually got motion sickness. You couldn't hear because of the white noise in the manufacturing suite, and couldn't talk with the host. It was a disaster.”
Neither side gave up. After re-huddling, they decided on two key improvements.
Since it was impossible to converse over the general sounds in the plant, they decided to connect via a web-based meeting platform (such as Skype or WebEx).
With that connection, the “V-PIP,” other CDMO personnel in offices, and the biopharma clients from their respective locations, could all message each other in real time as the tour/monitoring was taking place.
“We could at least ask and get an immediate answer to questions that came up, discuss what we were seeing or offer suggestions during the video.”
The second improvement: stabilize the iPad.
“We secured it to an IV stand, and the operator just rolled it around to where he or she was working. This time, it worked better than I would have imagined.”
Fit For Purpose
Like many readers, I’ve been in a variety of manufacturing facilities. I ask Graskemper if you can, for example, actually see an agitator inside larger equipment this way?
“This particular case was for a gene therapy,” he clarifies.
“If you are thinking large-scale small-molecule, and monitoring agitators and charging into vessels, an iPad on an IV stand is going to be difficult. You're better off in that instance with something like the Microsoft HoloLens or a hand-held camera.”
But the iPad-IV works well for modalities where the suites and equipment are smaller, and “at any facilities where space is at a premium, and it's difficult in normal times to insert a PIP into the environment.”
“I believe this V-PIP option for a gene-therapy suite may stick around – and get improved upon by others. When you can’t get close to the operations, this still provides that firsthand view of what's really going on in. It worked for us for a drug substance and drug product manufacturer.”
Did it initially feel like an interactive video game of sorts?
“Yeah,” Graskemper replies. The “avatar” just rolls right up to observe, for example, the drug substance manufacture step of interest and drug-product fill line, and it was quite interactive, communication-wise. And we could direct him as well.”
Graskemper envisions other uses for the V-PIP.
“It’s certainly applicable to monitoring analytical or purification processes,” he adds. “Our scientist could actually see the whole interface of that equipment real time, as if he were doing it himself.”
“And think of the uses for training personnel on both sides of the outsourcing equation.”
Back To Real-World
“This solution was created and implemented because we had a relationship that was one-hundred-percent collaborative the entire way through,” sums up Graskemper. “This was made possible via a strong relationship to begin with.”
Which brings us back to figuring out how to build those relationships in a time of coronavirus limitations.
For better or worse, the answer for that initial searching and learning about CDMOs is to also rely on video/web-based platforms and meetings.
But as per Graskemper’s comments above, ensure senior management participates to the degree necessary – on both sides.
We may end up judging our CDMOs as much on how they handle the virtual relationship as anything else.
And what we’ve established virtually in 2020 may become, so to speak, conversely augmented in the future by those real-life, close encounters of the pre-coronavirus kind.