Apr 09, 2021
| 3 min

Five Key Biomanufacturing Challenges Process Intensification Solves

To unlock the massive potential of biologic therapies, we need to eliminate manufacturing bottlenecks. Biologics manufacturing challenges can crop up in multiple areas, but leading biomanufacturers have found ways to circumvent and overcome these difficulties through process intensification (PI).

This article is posted on our Sartorius Blog. 
 


Process intensification refers to a wide range of initiatives that can maximize the efficiency of a bioprocess and make a biologic product more successful – and therefore more impactful for patients. Biomanufacturers can apply approaches to upgrade individual aspects of their processes or pursue holistic improvement across their enterprise.  

While intensification can remedy many specific bioprocessing problems, this blog highlights the five most important and overarching challenges process intensification solves. Read on for insights and commentary from leading biomanufacturers.


1. The Perennial Problem of Productivity

For many biopharma companies, the scientific concepts that power their innovative therapeutics have the potential to improve patient care while generating millions – or even billions – in annual sales. However, this all hinges on production keeping up with demand as markets shift and new opportunities arise. Increasing productivity means you will never need to leave potential revenue on the table or relinquish market share to future competition.

PI is one of the best ways for biomanufacturers to make more total product in the same amount of time. There are many technologies and approaches that can help achieve this goal. With greater production capacity, biopharma organizations can scale their processes to meet demand.

Mandar Dixit, Principal Process Expert at Sartorius, has worked with many manufacturers that were able to improve their productivity between three- and ten-fold through process intensification.

“Imagine you can get almost ten times more mass in the same batch,” he said. In a scenario where you previously needed to run a process ten times to meet market demand, “you can just do one or two runs, and you're done...That's where the power of productivity comes into play.” 



2. No Time to Waste

When you’re in the business of making life-altering therapeutics, production speed is always a focal point. The sooner process runs and regulatory approvals are completed for products like COVID-19 vaccines, the sooner those essential products become available for patients around the world.

However, many biologics’ complexities and long production cycles create impossibly tight timelines for biopharma companies. With so little margin for error, any small accident or production failure can create devastating ripple effects. Meeting key regulatory deadlines and getting to market ahead of the competition is crucial for ultimate success. This is particularly true for highly competitive spaces, like the biosimilar market, according to Kurt Brorson, Ph.D., VP, Technical at Parexel.  

“Often, if you're the first biosimilar on the market, you have a market advantage over the other ones,” Brorson said. To perform biosimilarity analyses against the reference drug, manufacturers need to be able to produce several successive batches in a compressed timeframe, not just the three batches associated with traditional process validation. Sometimes regulatory agencies even ask for additional batches to ensure a statistical assessment biosimilarity, if they have any doubts. Shortening timelines with process intensification lets manufacturers meet these additional regulatory requests without sinking their time to market.

For these and other reasons, biopharma groups often apply process intensification strategies aimed specifically at cutting production timelines. By making the same amount of product in less time, manufacturers increase their ability to meet their goals, get a product to market, and remain competitive.


3. More With Less: Using Facility Space Well

When it comes to manufacturing, every biopharma and contract manufacturing organization has finite resources. Arguably the most stringent limitations surround the manufacturing site itself: Building, fitting, and certifying a new site requires a huge investment of resources and time. Many companies don’t have the luxury of building or purchasing a brand-new site to expand their portfolio, change their processes, or make more of their existing products. This can limit an organization’s ability to provide more therapies to more patients, especially because they need to demonstrate manufacturing capacity in order to secure FDA approval.

In light of these challenges, many biomanufacturers use process intensification to downsize their process footprint to free up space and maximize their existing facilities. Reducing footprint circumvents site limitations and lets them open up new production lines, make more independent products simultaneously, and/or cut energy costs by shrinking GMP cleanroom spaces.   

With an intensified process that occupies a smaller footprint, biomanufacturers can meet demand and grow their operations without more massive capital investment. For those with new drugs awaiting approval, this allows biomanufacturers to demonstrate sufficient capacity to regulatory bodies and delay greater expansion investment until there are more positive indications for drug approval. 


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4. Constant Pressure to Bring Costs Down 

No business is immune to cost pressures, including the biologics and biopharma industries. Given the raw materials, equipment, infrastructure, and expert labor that goes into making and purifying a biologic product, it’s not surprising that many groups approach process intensification as a way to be more cost-efficient. This is particularly important because it can ultimately have an impact on therapeutic costs and accessibility along with the organization’s profitability.  

“We have to be mindful of the cost of goods when producing drugs,” said Kenneth Kang, Ph.D., VP of Manufacturing at Innovent Biologics. “We must take every opportunity to intensify our process in order to provide affordable, high-quality drugs to our patients.”  

Process intensification can help manufacturers bring down their cost of goods through improved process efficiency without sacrificing productivity.  Implementing process intensification can reduce up-front capital investment, maximize facility output, streamline labor expenses, and save overhead costs such as for water, energy, waste disposal, cleanroom maintenance, and beyond. 


5. Going with the Flow: Staying Flexible to Respond to Change  

The world of biologics moves fast; individual product needs and demand can change quickly and without much warning. Every day brings research breakthroughs, novel diseases, and new molecule discoveries that can shift the industry landscape. Biomanufacturers need to stay agile so they can react to these sudden changes. While a bioprocess may be well suited to produce a specific biologic over and over again, traditional processes and stainless-steel site infrastructure can be difficult to adapt to different product types or other necessary changes. As a result, those manufacturers might not be able to pivot fast enough to meet new needs or take advantage of new opportunities. Process intensification can help biomanufacturing efforts become more responsive as technologies, markets, and drug pipelines evolve rapidly.

In particular, the growth of commercial development and manufacturing organizations (CDMOs) in the past two decades has made increasing flexibility even more of a key motivation for process intensification. Since these organizations need to make a variety of biologics and potentially different modalities, process flexibility is essential to their business success. 


Looking to Solve Your Own Bioprocessing Challenges Through Process Intensification?

While these overarching biologics manufacturing challenges help provide a taste of the benefits possible through process intensification, the goal is really about solving challenges unique to each specific operation, including your own. There is no one-size-fits-all approach to process intensification, so it’s important to understand and consider all of the pros, cons, and available approaches before deciding which benefits you plan to prioritize and what specific changes will help you accomplish those goals.

To further your understanding and planning around bioprocess intensification, Sartorius has assembled a robust resource with essential considerations and expert insights from 20 biopharma and biomanufacturing industry leaders. To learn more about the world of process intensification and to guide your own bioprocessing decision-making process, download the report now!