“We had to scale up the scaling process itself”: An interview with BioNTech’s Dr Oliver Hennig
How do you develop, test and produce a vaccine within an extremely short space of time to combat a disease that little is known about? BioNTech knows the answer. Dr Oliver Hennig, Senior Vice President Operations, is a part of this success story. At HTGF’s High-Tech Partnering Conference (HTPC) on 12 April 2022, he’ll be talking about his experiences during the past months. In this interview, Dr Hennig explains how he and his team went about planning and implementing the production and distribution of Covid vaccines – and shares some of the most important lessons he learned.
Dr Hennig, have you had chance to pause for a moment and reflect on the past months?
I haven’t really, no, but events like the upcoming High-Tech Partnering Conference offer a good opportunity to do so. Time has flown by since March 2020. A lot has happened: setting up new processes and scaling up production, including searching for partners, are just two of the many tasks we’ve been working on tirelessly over the past two years. At the same time, we’re already in position to launch and expand production of other product candidates. We have lots of product candidates in the pipeline – some of our oncology candidates are already in late-stage clinical trials. So, in a nutshell: A lot has happened, but there’s more to come.
Dr Oliver Hennig, Senior Vice President Operations at BioNTech
What were the first steps your operational unit took after the outbreak of the pandemic?
Right at the start, I personally didn’t really hear a lot about the development of the Covid vaccine. My team and I were busy working on other things: We had to ensure that production of our oncology product candidates was able to continue during a global pandemic, as patients taking part in the clinical trials still needed to be provided with the medication. And here we faced the same challenges as other firms.
And when did your company start producing the vaccine?
It began when we wanted to produce the initial material for the clinical studies. But we were working to an incredibly tight deadline: Within two days we had defined and adopted reorganisational measures to ensure we were production-ready. We approached all tasks with a great deal of pragmatism and a results-oriented focus to ensure we didn’t lose any time. At one stage we had to move quite a large robot that couldn’t fit through the aisles or doors, so we cut open the building façade and hauled it out with a crane. And then just a week later we began the mRNA production qualification process for a clinical trial.
What changes did the development of the Covid vaccine bring to your unit?
The underlying processes and also the scaling up element were something we were already familiar with thanks to our work on the production of mRNA-based oncology product candidates. However, the volumes involved with the Covid vaccine took on a whole new dimension, just like that. With individualised cancer therapy, we produced much lower volumes of mRNA. So just a few grams, or even quantities measured in the milligrams. That’s because we produced vaccines tailored to individual patients, with one batch for one patient. All of sudden we needed 1,000 times that amount – literally kilos of mRNA. We needed to scale up the scaling process itself.
Can you tell us three key lessons that you learned during this phase?
Even though the initial studies on the vaccine’s effectiveness gave us a great deal of confidence, all decisions in this phase require a lot of courage – that’s the first important aspect. There comes a point when you just need to make a decision even though it’s still unclear how things will pan out. We had to make hundreds of these decisions to make the vaccine a reality, and we did so by consistently looking at the data and considering various scenarios. We always say that we’re not averse to taking risks, but are aware of the risks we take. The second point is: Good partners are vital. Experience in certain areas, such as internationalisation and the production of large unit volumes, is something that we simply didn’t have. Having the right partners, and then getting them on-board and excited about what you’re planning to do – that’s really key. And thirdly, we’ve learned that you can achieve a great deal within a very short space of time when you engage in a completely transparent, open and honest dialogue with the authorities – especially when both sides anticipate the potential questions and challenges that the other side may have.
What preparations did you take in order to produce large volumes?
Even before we received the data from the all-important third trial, we notified our partners and manufacturing network that we planned to ramp up production. We put in a lot of work ahead of time here, with our Marburg site coming on board, for instance, and also the purchase of raw materials. And in parallel to this, we began simulating various scenarios for vaccine distribution and storage. And the question we asked each time was: Can vaccine production be ensured despite various developments or obstacles that might possibly arise; have we covered all possible scenarios? You can never be certain, but we wanted to reduce the risks as much as possible – after all, our focus is here on protecting people.
And then that all-important data arrived and you were able to distribute the vaccine.
Exactly. And then the scenarios became real. We had to load up the trucks. I can remember it quite vividly: We delivered the first doses in German and Europe over the Christmas holidays. I knew where one of the first deliveries in Germany was destined for, and I insisted on driving there myself. It was at this point in time, December 2020, that things really started to get going. During that period, it felt like the team were working nine days a week to ensure the first batches of our vaccine arrived safely at the distribution centres and then ultimately reached the public.
What was it like working in your team at that time?
Working at BioNTech is a little bit like working in a family company. The team is at the heart of our work. We had a lot of experienced staff, but also a lot of new colleagues. And they needed to be brought together. For me, it was therefore important to have complete trust in the team. Equally, I also needed to be present myself and earn their trust. Empathy and team spirit are important. There were times when we were at breaking point. You need to know when to take a break, and to allow your mind and body to take a breather. It’s also important to have a healthy error culture. When people don’t want to admit to making a mistake, nobody can learn from it. And it also prevents people from working together to come up with swift solutions. Let’s not forget that mistakes also have the potential to uncover potential flaws in a process and give rise to new solutions – real innovation is only possible when you’re able to openly deal with setbacks.
How has BioNTech’s work changed?
Securing approval for the first mRNA-based Covid vaccine was a huge leap for us as a research-based biotech company, as well as for science and medicine. It was a proof of concept that mRNA technology is effective and offers a good tolerability profile. The founders of our company, Ugur Sahin and Özlem Türeci, invested over 20 years of basic research into this new class of active ingredients. Without their work, we would not have been able to successfully develop and deliver this product. We are continuing to focus on oncology, but we also aim to make advances in the field of infectious diseases and are looking to develop vaccines against malaria and TB, for example. We’ve not reached the finish line yet – we’re still very much at the start.
We’re looking forward to hearing the insights you’ll be sharing at this year’s HTPC. What can the audience expect?
I’d like to talk about my experiences over the past few years. When I joined BioNTech, we were already a fantastic research-based biotech company with outstanding scientists. But we didn’t even have our own website. Fast forward seven years, and we’ve now delivered over three billion vaccine doses in over 170 countries and regions around the globe together our partner, Pfizer. We’ve grown in all areas and have created a platform that we’ll leverage to continue developing medical innovations and making medicine accessible to all. This is the story I’d like to share.