Magazine Article | October 2, 2014

What Industry Trends In Biotherapeutic Manufacturing Tell Us About The Next 10 Years

Source: Life Science Leader
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By Trisha Gladd, Editor, Life Science Connect

When considering the topic he would present at the 11th Annual BioProcess International Conference & Exhibition, Ralph Lambalot, VP of biologics development at AbbVie, thought this year’s event would be a good milestone to look back at how far the industry has come in the past 10 years and what we can infer from the decade’s trends about where innovation will go in the next 10 years.

In his presentation, titled Delivering Innovation in Biotherapeutic Manufacturing: From Continuous Improvement to Disruptive Innovation, What Can Current Industry Trends Tell Us About the Next 10 Years?, Lambalot references a quote by science-fiction writer William Gibson, “The future is already here — it’s just not very evenly distributed.” In pharma, Lambalot believes there are pockets of innovation that exist today that can provide insight into what the future may hold for the bioprocess professional.

There’s been a lot of great work done with different industries for innovation models, and there are many concepts people are familiar with, like ‘continuous improvement’ and such being a source of incremental innovation. There’s also the concept of ‘breakthrough technologies,’ which can lead to some discontinuity in the marketplace,” says Lambalot. “Those sorts of innovations are hard to pick out in advance, but if the future is here right now, where are we seeing those pockets of innovation that may be pointing to what we, as bioprocess professionals, really want to keep an eye on? Then we can look at how it’s going to affect how we do our work.”

According to the book, Diffusion of Innovation, by Dr. Everett Rogers, adoption of an innovation follows an S-curve when plotted over time. Innovators are the first adopters, followed by early adopters, early majority, late majority, and then laggards, who are the last to adopt, usually because they have the most aversion to change. It is when the laggards begin to adopt that the innovation has typically hit its plateau. However, Lambalot says this isn’t always the case in pharma. While an innovation may have hit its plateau for adoption, companies should explore opportunities to drive that curve further and create more value for their product, their company, and the industry. He references monoclonal antibodies as an example.

Monoclonal antibodies (mAbs) have been in development since the late ‘80s. Once they were in clinical development, a lot of companies began pursuing monoclonal antibodies as a mode of therapy, and over the past 10+ years, there has been a growing number of mAbs out on the market. If mAbs are following the S-curve, then this may indicate the platform is maturing and running toward the end of its plateau for innovation. Lambalot argues the opposite. “The monoclonal antibody field is still very ripe for innovation. As biologists and clinicians, we are just now beginning to understand the mechanistic properties of our molecules. As process engineers, we are just now beginning to learn different ways of controlling the productivity of our cell lines as well as the actual molecular attributes of the antibodies as they are expressed,” he explains. “I think we are beginning to see an inflection in our ability to control those attributes, and even more importantly, we want to have an understanding of their relevance. Does it give us a superior efficacy profile, or does it give us a superior profile for formulation in stability?” It is these types of innovation that go beyond the typical, continuous improvement programs that focus on speed, cost, and quality. While those areas are important, Lambalot says it is likely other areas, like multispecific IgGs (immunoglobulin G) and antibody drug conjugates (ADCs), that will provide the most opportunity for true innovation.

The pharmaceutical industry is under constant pressure to come up with new, life-saving medications. However, these breakthroughs in science often take time and money, and with the pressure to produce something quickly using the most cost-effective processes, scientists and engineers are often restricted in their ability to innovate. To keep up with the industry Joneses, companies can sometimes be hesitant to focus on an area that may not appear to have an immediate payoff but could potentially lead to success down the road. Lambalot says innovators need to be given the opportunity to push the limits of their field in order to come up with the next big thing.

“Truly disruptive innovation happens when there is an outlier,” explains Lambalot, who references a concept written in Malcolm Gladwell’s Outliers: The Story of Success. He continues, “Somebody has taken a completely different tack on things, and those of us who may be aligned with the current model may look at that other technology as a real high-flier. Well, that high-flier could actually be the inception of a new platform that in, who knows, five or 10 years, the rest of us may be adopting. Then the next thing we know, we’re all conforming to that new technology.” Lambalot adds that while the high level of conformity driven by regulatory authorities also impacts innovation, organizations like the FDA are typically supportive of innovation as long as a company has a robust data package to support it.

Lambalot adds that the types of innovators a company employs are also vital to the fostering of innovation, as explained in the article “The Three Critical Innovation Roles,” written by Henry Doss on According to Doss, there is the broker, the role model, and the risk-taker. The broker is the one breaking down silos and sharing information across functions, in order to make connections between the people with the ideas. Then there’s the role model who understands the importance of risk-taking and nurtures an environment that supports risk-taking. Finally, you have the actual risk-taker — the person who is willing to go out and take a chance, even if it means failing. “You want that whole mix, because if you had the risk-taker alone, they may be pushing against bureaucracy or resistance, so you need the risktaker with the role model providing the support,” explains Lambalot. “The broker is sort of a catalyst. If they can make connections between like-minded risk-takers, they can really make something happen.”

So what do the next 10 years look like for biotherapeutic manufacturing? According to Lambalot, they look highly flexible — as in flexible factories. In his opinion, the age of the large-volume, single- product manufacturing facility has passed. “I’ve visited many facilities that were built by design for single products but have already been retooled for multiproduct manufacturing,” he says. “I think we’ve evolved our capacity thinking more from a tailor-made design to flexibility. Disposables are certainly helping with our ability to be flexible on the manufacturing floor.”

Disposables are also an area where he believes industry will need to work together to advance innovation. “We’re all jumping in line and adopting disposables, but I think as with anything in our industry, we are expecting our vendors to keep a keen focus on their assurance of supply and their ability to deliver on the quality and integrity of their products,” explains Lambalot. “The challenges for vendors of disposable products are going to be pretty high, and I think we, as an industry, really need to work together there.”

"The challenges for vendors of disposable products are going to be pretty high, and I think we, as an industry, really need to work together there."

VP of Biologics Development at AbbVie


While some groups argue for harmonization of this technology, there are others who argue that it’s important to be differentiated in order to have some competitive advantage. In the case of disposables, Lambalot argues that harmonization, commoditization, and redundancy of supply is what will drive competitiveness. “Biologics manufacturers need interchangeability of different disposable products to assure their own supply chains. I believe the vendors who achieve this will have a competitive edge in the marketplace.” In addition, he believes one of the biggest areas of innovation for single-use is the ability to drive continuous processing. “We see a lot of batch processing of monoclonals, and it’s certainly served us well over the years,” notes Lambalot. “But we might be at an inflection where engineers can look at the process economics of a disposable manufacturing line and really drive the productivity of those lines to levels that we haven’t been able to achieve with fixed stainless. I’m not sure we’ve necessarily seen that yet.”

Innovation drives the future of any industry, and pharma has some of the world’s most brilliant minds at the wheel. Collaboration and communication will be key in determining where we go from here. Most importantly though, success won’t come from pushing the mind to its limits; it will come from pushing it beyond.