In the pharmaceutical business, as with any other business, you can’t market what you haven’t brought to market. It’s no secret that few (if any) other industries face the scientific, economic, and regulatory hurdles in bringing products to the people as this one does.
The hurdles are there for good reason, of course. The U.S. Food and Drug Administration (FDA) and their international peers protect us all from ineffective, substandard, and even dangerous compounds, whether produced willfully by shady actors or by accident by those of high repute.
There are no shortcuts in drug development, and nor should there be. But a new breed of software solution, known as “digital thread” solutions, can shrink what has been a stubbornly wide pane of the premarket window from many months to a few weeks. For the most part, digital thread solutions are focusing on a long-neglected aspect of the drug-development lifecycle—the technology-transfer phase. However, these solutions are also proving highly effective in capturing product and process knowledge as production expands and evolves, thereby improving production efficiency and throughput, bolstering clinical trials, and smoothing the transitions to and from contract manufacturers.
Moving from Lab to Pilot Production More Efficiently
Digital thread solutions take the baton during the scale-up phase when drug candidates graduate from the lab to the pilot plant. This phase has historically wandered about a desert between the verdant drug-development and process-manufacturing software markets. Filling that gap involves a comprehensive tracking of the countless iterations and permutations involved in scaling up products from milliliters to liters to hundreds of liters and more—that is, to the critical mass at which a pharma or biotech company can take their results to the FDA and, with approval, to market.
While the products themselves are the main focus in this business, digital thread solutions’ greatest strengths lie their ability to provide unprecedented insight into the countless decisions and adjustments involved in developing the fine-tuned processes required to bring modern therapies from lab to pilot production and beyond.
Digital thread solutions supplant the point-solution systems as well as the all-too-familiar spreadsheets, presentations, and various other documents that manufacturing science and technology (MSAT) professionals including process engineers, chemists, logistics experts, and others involved in scale-up have used since the transition from pen and paper. While tech transfer has been digitized for some time now, it’s been far from cohesive. Digital thread solutions collect all relevant information in one place so that the knowledge created is immediately, consistently, and thoroughly documented—and globally accessible. Put another way, these solutions systematize the process of moving from the lab through scale-up and into commercial operations.
That not only speeds the tech-transfer process internally, but also makes things easier for regulators. Let’s say your engineers figure out a way to boost yield per liter by a factor of five through a series of changes—maybe a tweak to reagents plus a pH adjustment and a slight slowdown of an impeller. The explanations surrounding those adjustments historically might have resided on multiple documents written by a variety of specialists and then stored in different places.
Digital thread solutions provide immediate insight into the entire scale-up process, from conceptual justifications to experimental results. Rather than separately emailing a chemist in Belgium and a process engineer in Pennsylvania for PowerPoint slides and spreadsheets they created at different times and places, that information can now be available—internally and to gatekeepers standing between you and the marketplace—within a few keystrokes. An additional benefit: Such visibility demonstrates a structured, well-controlled process, instilling deeper confidence in the ultimate product.
Additional Benefits of a Faster Scale-up Process
While moving therapies from lab to market many months faster is attractive enough, the benefits of digital thread solutions for the pharma business don’t stop there. Because scale-up typically runs in parallel with clinical trials, and because these systems provide such deep and immediate insight into scale-up, preliminary results of those trials can inform drug modifications during the ongoing trial. Also, should a certain trial return anomalous data that seem attributable to a particular batch, one can quickly assess root cause and thoroughly account for the ensuing inconsistencies in the trial outcomes.
In addition, digital thread solutions extend into production by encapsulating product and process knowledge gained in scale-up for use down the road. That can make a huge difference when a drug is slated for contract manufacture and, conversely, when a company seeing falling demand for a different product decides to harness that spare capacity by bringing a drug back in-house after years at a contract manufacturer.
Drug development will never be field of immediate gratification. But digital thread solutions can bring surprising improvements to the scale-up process and beyond, shaving months off product-development timelines and getting products into the hands of marketers—and patients—faster.