Increasing Bioprocess Speed: Shortening Timelines With Process Intensification
Biopharmaceutical organizations are always up against time pressures, and their biomanufacturing is often a major limiting factor. Learn why many opt for process intensification to shorten bioprocess timelines.
This article is posted on our Science Snippets Blog.
No matter the size of your organization, time is an irreplaceable resource. In the complex world of biomanufacturing, it never feels like you have any time to spare.
Just think…how familiar is the feeling, “if only this step took less time.”
Biomanufacturing speed is always a paramount consideration, so long as it doesn’t come at the expense of quality. Biomanufacturers must meet key milestones on time to keep their product and business afloat. But the many constraints associated with bioprocesses can make it difficult to meaningfully shorten timelines.
Before discussing strategies, it’s helpful to step back and consider common time limitations and crunches to help justify why you might want to shorten timelines using process intensification.
Why Shorten Timelines?
Time pressures are present across the industry and meeting them can mean the difference between commercial success and failure for biologic organizations. You need to have a bioprocess and manufacturing site that can fit the timeline required for success. No matter how incredible your biologic may be, it won’t take off if the operation can’t move fast enough.
The inherent complexity of bioprocesses also means that time considerations extend beyond the process itself into the entire operation. For example, the industry standard for biomanufacturing plant utilization—or the time a site is actively making product— is usually about 80 percent.
Going further, some of the pressing deadlines that can motivate biomanufacturers to shorten their timelines include:
- Regulatory deadlines – Before, during, and after clinical trials, your team needs to answer to regulatory agencies. Your ability to follow through on these deadlines with expediency will likely improve your chances of success. For biosimilar companies, regulatory agencies often require the production of multiple batches to prove consistency and comparability. Thus, the faster a process cycle runs, the quicker you can complete these batches, and the sooner your product gets to market.
- Product delivery dates – Once your product is on the market, patients will rely on it. Therefore, the product needs to be delivered on planned cadences to keep the drug supply running smoothly. If hiccups cause lost batches or other delays, biomanufacturers still need to find ways to deliver their drug or else risk impacting patient lives.
- Public health crises – An epidemic, pandemic, or other massive public health crisis can create situations where specific biologics are needed on accelerated timescales. The demand and manufacturing efforts surrounding the SARS-CoV-2 vaccines provide a clear example of this scenario.
- Meeting investor milestones & fundraising – Organizations are always accountable to their investors, especially smaller companies and start-ups. Investors expect your team to follow through on promises made and internal deadlines set. Failing to do so for any reason can handicap your fundraising efforts.
Featured Report: Process Intensification: Key Considerations and Expert Insights
Download this report to discover the top five areas in which process intensification strategies can help biologics manufacturers achieve their organizational goals. Get data-driven insights from industry leaders and experts, from pharma to CDMOs.
Finding More Time with Process Intensification
Once you’ve realized that shortening your bioprocess timeline is essential, you must determine your approach.
Historically, manufacturers have turned to hiring more employees, enlisting the help of a contract organization, and building out parallel production lines to provide precious time. However, these strategies can be inefficient, and the total investment may outweigh the timeline improvements they offer. In the end, these tactics, though valid, can end up being short-sighted and ineffective in promoting your sustained success. More labor doesn’t always relate to more success.
Fortunately for the biologics industry, process intensification offers another way. Rather than trying to speed your bioprocesses up with additional hands and resources, process intensification can help you find efficiencies, increase site utilization, and reduce bottlenecks that shorten timelines.
With bioprocess intensification, biomanufacturers build efficiencies into their bioprocess that cut down the time it takes to produce a batch and ready the equipment for the next run. Among many strategies, process intensification can help you reduce the duration of your seed train, optimize cellular production and growth rate, cut N-stage bioreactor time, and streamline regulatory steps. In doing so, you can find methods and equipment that allow you to improve your bioprocess timeline rather than work around it. While these approaches can require some upfront resources, the returns are often greater and sustained since your team will be working “smarter,” not harder.
Key Considerations for Intensifying Process Timeline
While Process intensification is often the best way for you to shorten timelines, you’ll still need to determine which intensification approaches will work best for your organization. Some initial questions to ask yourself include:
- Is there a target batch production speed that you would like or need to achieve? First, you’ll need to carefully evaluate the length of your “runway” and determine a complete process timeline that helps you readily succeed, given maximum time available to you.
- How can you balance shortening batch production with managing risk and complexity to streamline regulatory approval? Individuals considering bioprocess intensification are not all in the same stage of development. Generally speaking, it's advantageous to have your strategies locked in early in drug development and clinical research (Phase 1 and earlier) to avoid regulatory hurdles associated with process changes. However, process intensification can still be highly effective later on in clinical research, provided the benefits outweigh the regulatory legwork associated with changing processes at later stages.
- Do you have the resources (time, labor, and capital) to make the upfront investment in intensified process development and reap the rewards later? For some process intensification strategies, you’ll need to invest some time, labor, and capital in process development to shorten timelines down the road. In short, you’ll need to factor this upfront investment into your calculations to ensure that the process intensification strategies you select can indeed help your business thrive.
We cover detailed discussions on each of these considerations and more in our comprehensive process intensification report, which also includes real-world scenarios and insights from bioprocess experts across the industry.
For example, you’ll learn about the pros and cons of using perfusion bioreactors to shorten timelines. Additionally, you’ll learn about intensification strategies with lower barriers to entry that can shorten timelines without much additional expense or regulatory burden. We also discuss the latest advancements in high cell density banking, single-use technology, and more that can help you move as fast as possible. To expedite your process development and biomanufacturing, download the report today!