Large Molecule

Benchmarking BioPharma’s Amazing Ascent

With study 12 in the works, BioPlan Associates’ keen analyses continue to reveal critical technology trends in the biopharmaceutical manufacturing space

By Steven E. Kuehn, Editor in Chief

Eric Langer and BioPlan Associates have been evaluating the biopharma and life sciences industry for nearly 25 years. This scrutiny became more formalized on the launch some 12 years ago of BioPlan’s familiar and perennial Annual Biopharmaceutical Manufacturing Report and Survey, its annual study chronicling technological trends and other forces shaping the biopharmaceutical manufacturing industry. As of this writing, Langer and his team are working to meet its response goals, and armed with that data, publish the findings in the 12th Annual Biopharmaceutical Manufacturing Report and Survey. Recently, Pharmaceutical Manufacturing Magazine had a chance to do its own survey (so to speak) and talk to Langer about his important work and what it’s been telling us about the ascent of this amazing segment of the industry.

PhM: Since you launched the Annual Biopharmaceutical Manufacturing Report and Survey, the industry has been afforded access to a very clear mirror reflecting important trends in biopharmaceutical manufacturing. What were the motivating factors behind starting the study and what was the industry like some 12-odd years ago?

Langer: Back 12 years ago, a major capacity crunch was being cited as affecting biomanufacturers’ ability to commercialize drugs. Suppliers and companies were raising serious concerns in the press and in private. But we were just not seeing quantitative evidence of the crunch. So, just as other industries measure capacity utilization, including the U.S. Federal Reserve System, we felt it important to quantify the severity of the capacity utilization problem in bioprocessing. Thus, our study began addressing strategic manufacturing issues, and has adjusted over time as these critical issues have shifted.

PhM: I’m sure there have been tremendous shifts perhaps you could compare and contrast (perhaps) early trends identified in the first four years of the study and the last four?

Langer: Looking back, the industry will likely remember worries about things like ‘burn rate’ for investors’ capital and concerns about survival. Companies were focused mostly on getting products commercialized quickly, and at any cost. Today, we’ve seen the industry mature dramatically, and rapidly. Now most in the industry would cringe at how ‘wild west’ manufacturing had been done back then! Today manufacturers are demanding their suppliers provide solutions that improve production efficiency, lower costs, and increase quality – all the while increasing the analytical technologies and measurability of their performance. So what we’ve witnessed in a short time is a maturation of a highly technical, highly regulated industry. I suspect in the near fututure we’ll be seeing case studies written on the effects that strategic manufacturing and planning had on the industry over the past 10 years.

PhM: With your long view, perhaps there was a manufacturing trend that appeared strong initially but then the industry pivoted, pursuing some other emerging technology?

Langer: The pendulum has swung many times and will continue to swing I have no doubt. Ten years ago, we could see the data focused on how to improve upstream titer, when that was resolved, it shifted the problem to bottlenecks in downstream purification. Now we’re back to working out more cost-effective, continuous processing technologies, both up and downstream, and how to produce more consistently (e.g., using single-use products, in multi-facility strategies, at increasingly smaller scales).

PhM: In your estimation, what would you say are the three, four or five top technological developments now serving BioPharma and likely to yield good things for the industry in the next 12 years?

Langer: It isn’t so much the individual technical developments that are as important as the way novel technologies are integrated into better, more streamlined, repeatable processes. Without better integration of each individual component the whole system will be hindered by its least effective part. Without probes and sensors, the automation systems can’t operate; a fully single-use facility can’t exist until all unit operations can be done as cost-effective disposables; improved manufacturing in either stainless steel or plastic may be less important than how well those components are integrated into a cost-effective system. At present, 100s of suppliers are investing $100s of millions into improving their technologies, and creating novel approaches – each is painfully aware of how challenging and slow it is to get something new evaluated by this industry. So even if a supplier has the world’s best technical improvements, if they come without a good, effective implementation strategy in this regulated environment, or if they can’t be integrated with other suppliers’ equipment, they just won’t be adopted.

PhM: Clearly understanding equipment strategies and other technical trends serves both buyers and sellers of biopharmaceutical manufacturing technologies. Who buys the study? Who do you think should buy the study?

Langer: Buyers of the study include both the biopharma drug innovators who want to benchmark their current manufacturing situation against 100s of their peers around the world, and suppliers to this industry who want to understand where biopharma budgets are being increased, and where biologics innovators are demanding new and better technologies from their suppliers. In addition, contract manufacturers are covered extensively throughout, comparing their operations to in-house manufacturers. Also, we break out U.S. and EU company responses, and compare them to “Rest of World,” so international trends can be identified, as well.

PhM: After 12 years of studying the landscape and the professionals that populate it, have you learned any essential truths? Perhaps it's as simple as "nobody ever wants to be first" or "necessity continues to be the mother of biopharmaceutical processing technology invention?"

Langer: The thing that continues to surprise me is the consistency in which both biopharma companies and their suppliers and service providers keep their eye on what needs to be done, and how effectively (albeit slowly) solutions arrive in this industry. The (lack of) speed of implementation of new technology means that many new entrants to this market need to realize that it takes a great deal of stamina and resources to shepherd through new and better technologies. Those that will succeed are the ones with the long term vision.

PhM: Was there ever a time when you were interviewing someone, or talking to colleagues and someone told you something that gave you real pause, and completely changed your mind on something?

Langer: Ah-ha moments in this industry are frequent. Very smart people are working hard on innovation that may cure disease, or increase access, and that enthusiasm and drive results in collaborative and creative ideas. These tend to be shared in an effort to further industry progress, rather than retained to maintain patent rights and trade secrets.

PhM: As you encounter the folks across the space who are engineering, buying and specifying the processing technologies, the one’s creating the processing lines, are there any "archetypes" you can identify? Perhaps it's the grumpy skeptic - who even after reams of data and field experience is not convinced that some new method will ever work for them?

Langer: The industry is populated by many unique characters. I find it interesting to hear stories of the ‘old days’ from those who are only now beginning to retire. It’s only now happening that the first pioneers, both drug innovators and suppliers are starting to leave the scene. And with them will go the infectious enthusiasm pioneers have for any new industry. Seriously, with biotech commercializing products only since the 1980s this is truly a young industry. I’ve heard some of the early industry explorers suggesting wistfully that they should write a tell-all book, or a ‘how it was’ history. But I’m not sure it’d make the bestseller list, outside of those members of that early, small community.

There are few sources that are as comprehensive and enlightening, but the study’s quality is predicated on its participants. Although the study period is coming to close, there is still time to participate in the collaboration — the results of which, many should agree, support the operational excellence of the industry and the quality and efficacy of the products they make.