May 14, 2021

The Manufacturing Agility Challenge in Biopharma: Expert Panel Q&A

By Cytiva

The extremely rapid development and production of vaccines and therapeutics to address the Covid-19 pandemic are an undoubted achievement of the biopharma industry.

Industry insiders, however, are all too aware of challenges this effort revealed, especially for turning innovation into the necessary volume of products. According to data gathered for the Global Biopharma Resilience Index – which was published by Cytiva in partnership with the Financial Times – just 27% of pharma and biopharma executives say that their manufacturing processes provide their organization a competitive advantage. Furthermore, across the five areas of focus in the index, manufacturing scores are the second lowest overall (see chart below).

Global Biopharma Resilience Index

In a series of in-depth interviews and expert discussions, we gathered a panel of sector leaders to look more deeply into the nature of this challenge and ways to overcome it.

How has the experience of responding to the pandemic reshaped what manufacturing agility looks like in biopharma?

Piers Ingram (CEO and co-founder, Hummingbird Bioscience): For one, new types of networks and collaborations that are completely unprecedented have developed. We could not have delivered on our program [an antibody treatment] without the participation of several large pharma companies lending us capacity for bio manufacturing. Our role was early development and then transferring that into one of the major pharma companies to do the large-scale GMP manufacturing. It is pretty unheard of to have the drug substance manufacturing done at one company and the drug product manufacturing at another. But what’s really exciting is that we’ve built networks and relationships between people in different organizations that can show when there is an opportunity to do things better.

Stanley Erck (President and CEO, Novavax): Currently, speed is everything. Every day counts and that requires collaboration. Novavax started with zero manufacturing sites in January of last year. Now we have eight in seven different countries and we use product like we never would have, as well as supplies of raw materials that we never would have forecast a year ago. To be honest, it is a stretch. We’ve all been surprised by the demands on supply chains and balancing those. For example, the industry didn’t anticipate the need for bags that you use to make manufacturing process filters. They’re in short supply. So, you have to make sure through these collaborations that there aren’t people who have a year’s worth of inventory and somebody who has zero. That collaboration is really crucial to flexibility.

Such extensive cooperation is likely to require advance data gathering and sharing. This leads to another challenge identified by our research: only about 20% of the executives to whom we spoke said that the adoption of digital and emerging technologies such as AI is already common within the industry in their countries. How will getting better use of data change manufacturing agility?

Michelle Xia (President and CEO, Akesobio): Manufacturing agility and flexibility are very important for an R&D company like ours. We have quite a few products in the development stage, but we cannot a build a factory for just one compound. So, manufacturing flexibility is very important for us. The manufacturing reality right now for us is that we need to pursue very high-level digital applications to achieve that flexibility with partners. If you don't have a very good digital control system – things like GMP compliance and data tracking – then manufacturing becomes very costly.

Kiran Mazumdar-Shaw (Chairperson and managing director, Biocon Limited): It’s absolutely crucial for manufacturing to be both agile and flexible. Using data and analytics, we need to revisit a lot of our manufacturing processes and really focus on how quickly we can pivot from one product to another. Regulatory simplification in a big way is also going to be extremely important going forward. With all the digital technologies and sensors that we have now available to us to show compatibility, I’m sure we can simplify regulations and make manufacturing far more efficient.

Speaking of regulation, where do the current debates over vaccine export restrictions leave the industry’s ability to respond with agility?

Stanley Erck: Governments are afraid of not having product for their citizens and there’s a tendency to close borders on a variety of things, including raw materials. We have to make sure that doesn’t happen. The industry needs everything to flow freely. As I said, we’re manufacturing product in seven different countries right now. We need complete flexibility to be able to pull materials and people back and forth. We should all work to help convince the various governments involved that you’ve got to keep borders open.

Are there other areas where the industry should be looking to enhance manufacturing agility?

Martin Meeson (CEO, Fujifilm Diosynth Biotechnologies): One single thing that will also increase resilience is having simpler and more standardized processes as we go forward. We have created many, many different ways to do very similar things within this industry. We have to bring a huge increase in the level of standardization. It’s much easier for a supplier to keep in stock three things that I’m ordering rather than 20 to 30. More generally, we need to make sure that every time we do something, we’re maximizing the output from the resources that we’re using and looking at new ways of making things as well – like continuous manufacture, where there’s a significantly increased output for reduced usage of resources.

Dr Chris Chen, (CEO, WuXi Biologics): Picking up on continuous manufacturing, our industry should be looking at transforming the entire manufacturing process. If you look at the chemicals and petroleum industry, all manufacturing is continuous, but pharma is [still] batch processed. If the petroleum industry went to batch processing, they would go bankrupt because they have to rely on very high efficiency. The next stage for pharma is to go from batch to continuous.

Kiran Mazumdar-Shaw: When you look at resilience in these kinds of times, it’s really about how fast you can pivot, how fast you can address the scale-ups and surges that you have in capacity planning. That’s where you have got to make sure that your cost efficiency is absolutely optimal, despite the of pivots and changes you have to adapt to. You have got to make sure that your production capacities are being managed in a way that does not lower that cost efficiency. India’s vaccine companies thrive because of economies of scale and because of the variety of vaccines they produce. They’re able to quickly switch and pivot their lines from one vaccine to another very rapidly because they are optimized in this way.