To keep up with the world’s growing demand for inexpensive and effective life-saving medications, biopharmaceutical companies need to equip themselves with tools, strategies and skillsets that allow them to optimise their manufacturing workflows.
Here, we discuss the five top trends that we predict will most strongly influence the industry’s search for a streamlined bioprocessing workflow in 2021.
Demand for biosimilars in emerging markets
Biosimilars are an attractive option for emerging nations because they’re cheaper than the corresponding innovator drugs. In fact, McKinsey expects global biosimilar sales to more than double to $15 billion by 2025 … and it predicts that about $5–8 billion of these sales will come from emerging markets.1
As more patents expire, biopharmaceutical companies are racing to capture their share of this growing market by develop cheaper alternatives. However, there are a number of hurdles to overcome along the way.
First, the field is competing to produce biosimilars for the same 10–15 biologic drugs. At the same time, the companies behind the innovator drugs are streamlining their own manufacturing processes, lowering drug costs and putting even more pressure on biosimilar developers to create new efficiencies while maintaining accuracy.
Manufacturers cannot receive approval for their biosimilars until they prove that these molecules are equivalent to the innovator molecules. Consequently, manufacturers spend a lot of time and money proving the biosimilarity of their molecules with the innovators.
But as they race to be first, keeping costs low becomes a huge bottleneck. Furthermore, it is crucial that these companies achieve approval not just in emerging markets, but also in the EU and US, where regulations are much stricter and require greater diligence.
To be efficient in manufacturing, it is essential that manufacturers build facilities that can produce more than one biosimilar molecule. With the ongoing pandemic, it is even more imperative that biosimilar manufacturers plan redundancies that will enable them to adapt to the needs of the market.
Process intensification
Demand for faster production and cheaper drugs can be met with one approach: process intensification. Intensifying a bioprocess means increasing productivity with less: less time, less input material, fewer steps, a shortened timeline and a smaller facility.
Process intensification is not a new concept; but, in 2021, we expect biopharmaceutical manufacturers to embrace the benefits that process intensification provides in response to increased demand. Streamlining a bioprocess allows manufacturers to produce more product and cut costs.
These savings can then be reinvested in the development of new modalities. Because of how efficient a process can become, a manufacturer can invest in a smaller facility, reducing both their capital investment and their carbon footprint.
One way to simplify process intensification is to utilise single-use products. Instead of having to clean large stainless-steel bioreactors with harsh chemicals, manufacturers can rely on single-use bioreactors that don’t require cleaning.
With advances in rocking motion and stirred tank bioreactors, one has a choice of flexible upstream single-use seed train options that lead to further flexibility and a lower cost of goods.
Overall, this reduces energy use as well as the probability of cross-contamination during changeover to a new modality.
Flexibility within manufacturing platforms
In addition to unprecedented demand for speed and efficiency, manufacturers are also being tasked with producing a wider diversity of pharmaceutical products today than ever before.
Scientists are reaching beyond traditional molecules to develop novel modalities, including viral vectors, nucleic acids, fusion proteins and complex drug conjugates, just to name a few.
These novel modalities require the development of new manufacturing platforms, which means that to keep up, biopharmaceutical manufacturers need to be flexible and able to transition from indication to indication to meet the needs of the latest health threat.
The COVID-19 pandemic, for example, has put pressure on biopharmaceutical manufacturers to remain nimble as researcher develop novel vaccines and treatments for it.
The world will see the world’s first ever mRNA-based vaccines come out during this pandemic, for example, demonstrating the value of more flexible biologic manufacturing platforms.
mRNA is a platform that will demonstrate its value beyond COVID-19: the same process can be used to produce vaccines against different indications, allowing vaccine manufacturers to easily switch from one vaccine to the other in the same facility.
This enhanced flexibility means that biopharmaceutical companies can develop vaccines much faster in response to outbreaks or pandemics. With a simple production process, it might also facilitate local production, which would ultimately result in better access to vaccination.
In 2021, biopharmaceutical companies would be smart to invest in platform workflows because they will lead to more efficiency, greater flexibility and more impactful pharmaceuticals.
Cellular and genetic approaches
Some of the most common bioprocessing workflows today involve advanced therapies, which are based on genes, tissues or cells. Although only ten cell and gene therapies have been approved by the US FDA, there are more than 1000 different therapies in the pipeline … and that pipeline is growing fast.
The FDA predicts that it will approve 10–20 cell and gene therapy products by 2025.2 Furthermore, the gene therapy market is expected to grow at a 30% compound annual growth rate between 2020 and 2030.3
Some approved therapies are showing success, such as Zolgensma from Novartis/Avexis to treat spinal muscular atrophy. And the future is looking bright as biopharmaceutical companies expand beyond rare disease to oncology and other chronic conditions.
Bioprocessing 4.0
One of the major goals of biopharmaceutical companies is to automate their bioprocesses to reduce inefficiencies caused by human error. The favoured approach is Bioprocessing 4.0, a concept in which all tools are connected digitally, thereby connecting the entire workflow from end-to-end.
This approach allows manufacturers to automate the production of biopharmaceuticals and even improve their processes with sophisticated feedback loops and the use of machine learning. In all, Bioprocessing 4.0 can change the way biopharmaceutical manufacturers make drugs.4
The prevailing challenge in the industry is the need for produce therapeutics rapidly and Bioprocessing 4.0 is the most impactful approach to streamlining a bioprocess to date.
Two areas that must be streamlined are equipment cleaning and data validation. A manufacturer might solve this by introducing fully automated, upstream single-use bioreactors to their facility.
These bioreactors would use a high cell density fed-batch culture or perfusion culture to enable rapid, flexible production.
They would have single-use inline sensors that would provide scientists with information in real-time, helping to determine critical quality attributes (CQAs) and adjust the process while it is running.
These facilities would also replicate their bioprocesses digitally to help scientists improve their process controls or to run simulations when needed. This type of set-up would cut manufacturing times by weeks, as it would reduce the need for offline data testing and for equipment cleaning.
Putting it all together
Even before the COVID-19 pandemic, biopharma manufacturers were engaged in a competitive race to streamline vaccine and biopharmaceutical development.
Increasing productivity by intensifying bioprocesses and adopting Bioprocessing 4.0, a biopharmaceutical company can scale-up the amount of product they produce with fewer resources.
This yields shorter manufacturing timelines and increased flexibility. When a manufacturer can synthesise products more quickly, they have the resources to adopt more modalities, such as cell and gene therapies, into the same facility.
Because of the shifts we’ve seen in manufacturing practices during the past few years, we believe 2021 will serve as inflection point in how bioprocesses are designed so that the industry will be better prepared to handle biopharmaceutical production in the future.
References
- www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/whats-next-for-biosimilars-in-emerging-markets#.
- www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics.
- www.globenewswire.com/news-release/2020/08/04/2072578/0/en/The-global-cell-and-gene-therapy-market-by-revenue-is-expected-to-grow-at-a-CAGR-of-over-30-90-during-the-period-2019-2025.html.
- www.wsj.com/articles/moderna-and-pfizer-are-reinventing-vaccines-starting-with-covid-11605638892.