Getting More Flexible Bioprocessing Through Process Intensification
Given that organizational priorities and needs can change quickly in the biologics industry, biomanufacturing flexibility can be a lifesaver. Find out how process intensification strategies can help you increase flexibility in your bioprocesses without sacrificing output or quality.
This article is posted on our Sartorius Marketing Blog.
Being nimble plays an important role in the business of biologics manufacturing. Given the complexity of bioprocessing and the growing number of biologic drugs, biomanufacturers must frequently adapt to match new demands, respond to market trends, make new products, further develop bioprocesses, and more. As a result, biomanufacturers that are not able to adjust course quickly can struggle to stay relevant in this fast-evolving market. Biologics manufacturing sites that are built to use a limited configuration of bioprocesses and produce only one biologic or modality may end up operating at suboptimal levels.
While process intensification is commonly thought of as a way to increase productivity, shorten timelines, reduce footprint, and lower the cost of goods, it’s also a key tactic for building more flexible bioprocessing operations, it’s also a key tactic for building more flexible bioprocessing operations.
Flexibility is near the top of the list in terms of the value you can get from process intensification. Among other things, it can allow for more investment risks because you can jump from one molecule to another.
We could all stand to be a little more agile, right?
In this blog, you’ll learn more about how bioprocess intensification can increase flexibility at your biomanufacturing site, and how you can use it to tailor your bioprocesses to accommodate dynamic demands.
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Why Intensify to Increase Biologics Manufacturing Flexibility?
The need to adapt to changes in biologics manufacturing stems from the nature of drug development and the biopharmaceutical market. Sources of these changes include:
- Clinical Trial Results — It’s no secret that most drugs that enter phase 1 trials ultimately do not receive regulatory approval. This means organizations need to be able to change out bioprocesses quickly to develop and manufacture other products in their pipeline without significant disruptions.
- Multi-Product Manufacturing — Many sites, particularly those at mid and large biopharmaceutical companies and CMOs/CDMOs, are responsible for making multiple different biologic products or even different modalities. With more biologics to make, there is an increased likelihood that you’ll want to seamlessly switch between them.
- New Indications & Demand Fluctuation — The world of biopharmaceuticals evolves rapidly. This means demand for your biologic can change over time, particularly if your drug is approved for new indications or a new competing drug reaches the market. Furthermore, public health emergencies can drive demand for specific products. In all cases, it pays to be able to easily adjust your biomanufacturing output.
- Necessary Bioprocess Alterations — Sometimes organizations realize that their established bioprocesses are no longer optimal. For example, organizations may need to alter their bioprocesses because of raw material supply chain challenges, changes in cost pressures, environmental impact, and beyond.
With process intensification, you can build flexible bioprocessing sites that can cope with all these sources of change. Think of process intensification as an assembly of steps where you have elements that are common to different processes. You can change elements to continuously fine-tune your process to get what you want at the end.
There are many process intensification approaches available to help you “fine-tune”—you might consider switching to single-use bioreactor systems, revamping your seed train, moving to modular facilities, and more.
Key Considerations for Achieving More Flexible Bioprocessing with Process Intensification
While process intensification is a great way to build more flexible bioprocessing, every organization has a different optimization path. You’ll want to carefully think through the available approaches to find the best fit. To start preparing, consider:
- Where in your process do you experience the greatest difficulty with product changeover? While it may seem obvious, it’s important to know EXACTLY where flexibility is needed most. You’ll want to holistically review your entire process to find those bottlenecks and carefully approximate the benefits of extra flexibility in those areas. When resources are precious, start with low-hanging fruit!
- Are you aiming to produce multiple products or modalities simultaneously within the same facility? Consider current and future needs as well. The extent of process flexibility you need depends on how you use your site. Is your site producing only one product at a time? Multiple products in parallel or sequentially? Are you producing one modality or multiple? The greater the diversity of biologics you intend to make at your site, the more flexibility matters.
- When scaling up to commercial production, will you likely require large stainless-steel equipment – or will it be possible to continue with single-use technologies? Flexible bioprocessing is great, but not if it ends up getting in the way of other organizational needs. Chiefly, consider the scale-up of your product. Some technologies, like single-use bioreactor systems, can’t yet match the scale possible with less-flexible large stainless-steel bioreactors. If you must ultimately work at these scales, you’ll want to strategize early for any eventual scale changes, so you can be prepared to change equipment or add production lines.
We can help you answer these questions in detail with our comprehensive process intensification report. The report includes real-world scenarios and insights from bioprocess experts across the industry who have implemented process intensification strategies in their own facilities to increase flexibility. Among other things, you’ll learn about the advantages of single-use bioreactors, “pod”-style bioprocessing facilities, CMO-specific challenges, the role of N-1 bioreactors, and more. To start working towards more flexible bioprocessing, download the report today!