In the highly regulated environment of Pharmaceutical Technical Operations, there are clearly defined ways of doing things. Processes, timelines and new technologies are paramount. Whether you are operating a filling line or conducting studies or a technology transfer, that’s just the way it is. That is, until it’s no longer good enough.
The pandemic threw many commonly held conceptions on their head. When I was offered the opportunity to lead the technical transfer program for a potential medical solution for COVID-19 patients, I was thrilled. I have to admit to also being a little nervous, especially when it became clear our ambition was to go from zero capacity to doubling the global production capacity for this therapy in less than seven months.
It usually takes 18-21 months from project initiation until delivery of medicine to patients. It was clear this wouldn’t be acceptable given the global urgency of the pandemic.
The world was crying out for medical solutions, and I was kept awake at night thinking about how we would achieve this with a completely new therapy, in a virtual, working-from-home setting. All while making sure this work didn’t impact the ongoing supply of our existing medicines to millions of patients around the world.
This feat would require a network effort never seen before. We would need to re-write and re-think many established processes. To help us achieve this, the global transfer team and I asked key questions:
What are the essential requirements to ramp up manufacturing in this emergency situation?
How can we make decisions faster, and who needs to be at the decision-making table?
How can we align the organization to think and work differently to change established processes and deal with unknown complexities?
How do we bring the entire Pharma Technology network onboard to support our ambition?
How will we best support each other during challenging times to ensure our work remains on track?
What followed were intense times. Established processes instill security and routine. It took bravery to try something new. Cutting away all but the essentials is a lot harder than it sounds, too. It required tough choices and fast decision-making by our senior management.
Ultimately, the hardest part was the mindset shift – thinking outside the box and being unafraid to work differently across functions, geographies and even companies. Yet only by asking the right questions and embracing this new mindset were we able to achieve one jaw-dropping milestone after another.
One such achievement? Completing the drug substance technology transfers required for this potential therapy at our Vacaville, U.S. facility in just 123 days, when this usually takes nine months (for more info
Precise planning of the shipping, quality testing and “live” rapid response coordination between the two sites significantly reduced timelines and streamlined processes. The final stage – packaging the medicine in less than 10 days at our site in Kaiseraugst, Switzerland – required flexibility to overcome non-standard, evolving export requirements. This ensured that more than 30,000 patients could receive this first shipment.
It’s truly remarkable to reflect on these achievements and the people who made them possible. The lesson? By asking the right questions and having the right mindset, our teams can not only improve well-established processes, but make the “impossible” possible.