The COVID-19 pandemic has caused unprecedented disruption in most industries, with pharmaceutical development and production high on the list. With people around the globe dependent on the availability of life-saving therapies, drug discovery and production can hardly afford the interruptions.
Industry leaders increasingly are turning to advanced technology to avoid, or at least shorten, interruption caused by the virus. Outsourcing-Pharma (OSP) recently spoke to two executives from technology providers--David Sprinzen (DS), Vantiq’s director of marketing, and Bryan Debois, director of industrial AI with RoviSys--about the challenges created by COVID-19, and how technology may provide ways to clear such obstacles.
OSP: Could you please provide a ‘nutshell’ version of some of the most glaring issues with biologic and pharmaceutical manufacturing, pre-COVID-19?
DS: Prior to COVID-19, there were already three glaring issues facing biologic and pharma manufacturers. First, by the very nature of their work, manufacturing workers are at a high-risk of infection – particularly from an illness brought inside and spread among folks working in closer quarters. Such infections can spread quickly before anyone even knows it.
Second, because of existing labor shortages across all manufacturing sectors, pharma manufacturers tended to run on reduced crews. They need to get more done with less – so downtime, whether it’s via some sort of mechanical issue or a group of sick workers, can be far more disruptive that in a typical manufacturing facility.
Now with COVID-19, those reduced crews have become skeleton crews as some workers are contracting the disease, or simply not comfortable coming into work.
Third, because of the regulatory and validation requirements, pharma manufacturers are less able to move quickly and adapt to a change in situational awareness, whether that’s the need to fix a piece of equipment or to respond to some kind of human threat.
All three of these issues point to the need for real-time awareness, which can be provided via technology.
OSP: Could you please share any of these challenges that COVID-19 shined a spotlight on?
BD: All three of the issues above were exacerbated by COVID. First, manufacturers don’t simply need to protect their workers (and thus their operations) from the typical worker safety concerns, or a standard illness anymore; they have a pandemic on their hands, and they need to make sure folks can work safely.
Further, many pharma manufacturers have been forced, for social distancing reasons, to make their skeleton crews even smaller. At the very least, most have kept non-laboratory and plant-floor worker at home – such as folks in the office and maintenance crews.
The distance, while a necessity, has slowed the production process. You can’t simply walk into an operations manager’s office and ask for more resources, or spin over to the maintenance crew and ask them to fix a faulty piece of equipment.
Finally, with fewer office workers in-house, situational awareness becomes even more difficult to monitor. After all, if you’re focusing diligently on delicate work like biologic manufacturing, you can’t really keep an eye out for a situational change – or even whether or not you are carefully socially distancing in the lab.
And now, your office-based colleagues aren’t on-site to help you keep an eye on things like that.
OSP: What previously undetected (or maybe ‘under-recognized’) issues did the pandemic stir up?
BD: Another is maintenance teams. We've seen a huge uptick in customers asking us about what they can do about remote maintenance teams. There's been, over the past 5-7 years, kind of a brain drain on maintenance teams as older and more experienced maintenance resources have started to retire.
Customers tell me where they once had maintenance teams that had 15- to 20-years’ experience on average, now their most experienced person has about five years. So they already were feeling that pressure. And now you've got a maintenance team that's remote because of the virus.
A third is that many pharma manufacturers are still using paper batch records that follow the pharmaceutical batch through “travelers” – a fancy word for a plastic folder. This system is still used because paper is an unchangeable source of the truth, which is required for validation.
However, those paper travelers can get lost or destroyed, and a batch without a traveler cannot be sold. Currently, a review of the paper records requires someone to physically be present at the facility.
Ideally, one could build an alert using Vantiq that notifies a reviewer that a completed batch record is ready to be reviewed digitally. In a post-COVID world, anything that can be done to reduce unnecessary physical contact is worthwhile.
OSP: What are some of the ways in which industry professionals have tried to cope with these challenges? Which have been effective, if any, and which have fallen short? What technologies, both existing and newly emerging, have come to the rescue?
BD: Pharma in particular just can’t stop manufacturing. People need life-saving and life-sustaining medications, even during a pandemic. Smart technology can be effective in keeping them in business and keeping employees safe.
Vantiq, for instance, calls its newest solution a ‘back-to-work accelerator.’ Using its software development platform, customers can connect a variety of technologies in an IOT network – thermal imaging cameras, for instance, which ‘look’ at employees as they enter a facility and literally take their body temperature; we can then flag those with temperatures for further evaluation – in real-time, not after the worker has been in the lab for 30 minutes interacting with co-workers.
That’s where some organizations are failing – their data alerts are not real-time. With VANTIQ, security personnel can be alerted of issues in the moment.
The Back to Work Accelerator also has the ability to track movement of employees through a facility, so you know who an infected employee may have had contact with. We're hearing from customers that this is their number one concern – the safety of their employees and containment of infection. Remote maintenance is another benefit.
Vantiq has the ability to help automate maintenance, to get things fixed before they break. The system can trigger e-mails and create work orders automatically.
OSP: Can you think of any lessons that life-sciences professionals have learned in the months since the pandemic hit?
BD: If our customers are learning anything from this pandemic, it's that the manufacturers that respond quickly, that can be agile, they are going to be the ones that can weather these types of storms. They are the ones who are adapting quickly to a new normal. and that won’t end after COVID.
Adopting integrated, real-time technology that allows them to act on data as it comes in will be a key differentiator. Those are the manufacturers who have a long-term vision for what COVID means.
We’re not talking about ripping and replacing whole systems. We’re talking about being able to cross-pollinate and orchestrate the communication and the oversight and the coordination of all a manufacturer’s current systems in a better, smarter and faster way.