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

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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.

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