More than ever before, this past year has underscored the need for rapid, scalable, and cost-effect vaccine, diagnostic, and therapeutic development. It also showed the importance of flexibility and the need for the industry to adapt to changing market demands. We expect these factors will continue to shape biopharmaceutical manufacturing in this coming year. Below are our top five industry trends to watch.
mRNA Platform Popularity
Around the world, everyday life in 2020 seemed to hinge on the development of rapid, scalable vaccines. Some manufacturing platforms make this easier than others. For example, mRNA-based vaccines are faster to develop, more flexible, and easier to manufacture. These advantages have proven incredibly valuable in the race to develop a vaccine against SARS-CoV-2.
mRNA vaccine platforms can be easily adapted for different indications. This allows the facility to switch to current needs, instead of taking the time to fit an entirely new facility. These vaccines also are somehow easier to manufacture than many of the alternatives because they rely on enzymatic synthesis rather than cell culture.
mRNA vaccines can be developed at an unprecedented speed, much faster than traditional vaccines because they are relying on a platform process, rather than having a process tailored to the disease. This proved important during COVID-19, and we know it will be important for any other future pandemic situations.
While we hadn’t previously seen an mRNA-based vaccine approved in the U.S. before 2020, we can expect this platform to become increasingly popular given its recent success.
Increased Biosimilar Demand In Emerging Markets
Emerging markets are increasingly looking for more cost-effective therapeutics. As more biological drug patents expire, biopharma companies are able to compete with biosimilars. And there is broad demand for cheaper alternatives. By 2025, McKinsey & Company predicts that the emerging nation biosimilar market will be nearly half of the total market, at around $5 to 8 billion.
However, there are some challenges that will need to be addressed to meet this demand. First, biopharma companies are all attempting to develop biosimilars for the same 10 to 15 biologics, creating a lot of competition with each other. The speed at which they reach the market will be important because developers with the first biosimilar alternative to the biologic will have a larger market share while they wait for other players to follow. They are also attempting to improve their biomanufacturing processes so speed can be achieved in the most cost-effective way.
New technologies and tactics are needed to make real progress with both speed and cost. For example, flexible facilities that are able to produce more than one biosimilar molecule will allow manufacturers to pivot quickly based on the market needs. We predict there will be an increased focus on streamlining protocols in order to meet the increased demand we are seeing for biosimilars.
Growing Interest In Cell And Gene Therapies
It is clear that cell and gene therapy is a growing therapeutic area. While there are only 10 total cell and gene therapies approved for use in the United States right now, the FDA anticipates that by just 2025 there will be 10 to 20 new cell and gene therapies approved each year.
But to achieve this level of growth, manufacturers will need to tackle a few challenges. Recently, regulatory agencies have established approval pathways and published new guidance that gives developers clearer insight into the agency’s expectations. We should see this help streamline the process as more biopharma companies apply for approvals. In addition, because this area is still not yet mature, production capacity is limited. We predict that in 2021, we will see even more CDMOs emerge that specialize in viral vectors to help tackle this challenge.
More and more aspects of our daily lives are becoming automated and the biopharmaceutical industry is no exception. The industry has been moving toward Bioprocessing 4.0 – the concept of connecting all tools in a bioprocessing workflow digitally – for years. Given the continued need to produce therapeutics faster and for a lower cost, we will see this trend continue.
There are two big areas where Bioprocessing 4.0 can help. First, the creation of a more automated process with similar automation platforms where different equipment of various unit operations can talk to each other. Second, data validation with in-line sensors and multivariable analysis using advanced software tools. To make this possible, manufacturers can implement upstream single-use bioreactors. And when these bioreactors have in-line sensors, manufacturers can access data in real-time, which allows them to adjust protocols as soon as something is off. Further, the team can recreate the workflow digitally to run simulations or determine how to improve process controls. This ability means the team can cut out the need for offline data testing. Ultimately, these changes can cut down timelines significantly.
Sustainability Through Single-Use Products
Many manufacturers are leveraging single-use technologies. While these can streamline protocols and improve flexibility, they also can help improve sustainability. Single-use products allow the manufacturer to avoid strenuous cleaning protocols usually required with stainless steel products. In turn, there is no need for harsh chemicals that are bad for the environment. For companies, this approach saves the facility time and resources typically spent on cleaning. In addition, it prevents energy and water waste. Further, single-use products allow the facility to change between modalities easier without worrying about cross-contamination or requiring a second set of equipment, which in turn can reduce their physical and carbon footprint.
However, it may seem counterintuitive that something disposable would actually be more sustainable. Studies have shown that plastic waste from the biotech industry is actually extremely low at just 0.01 percent. This is because the industry is so regulated and well-controlled. Actually, in a comparison of 18 different environmental categories, single-use was optimal compared to traditional facilities across the board.
When implemented well, single-use products can improve a manufacturer’s sustainability — in addition to a whole host of other benefits.
The Year Ahead
The COVID-19 pandemic helped show the bioprocessing industry the areas we need to focus on to become more flexible and efficient. Today, we are working on implementing all of these lessons learned, knowing the extent of what we can achieve.
About the Authors
Head of Market Entry Strategy, Protein-Based Therapeutics, Sartorius
Priyanka Gupta has been working with Sartorius since 2007, where today, she is the Head of Market Entry Strategy for Protein-Based Therapeutics. She holds a Master’s in Chemical Engineering from Florida State University in Tallahassee, FL. Most recently, she developed process models to understand the economic impact of implementing Process Intensification for various modalities and scales. Prior to that, she was a downstream application scientist. Before joining Sartorius, Priyanka was a Process Development Scientist, Downstream at Amgen for more than four years.
Head of Market Entry Strategy, Viral-Based Therapeutics, Sartorius
Amélie Boulais has been working with Sartorius since 2008, where today she is the Head of Market Entry Strategy, Virus-Based Therapeutics at Sartorius. Amélie earned her Master’s Degree in Biotechnology Engineering from the Biotechnology Engineering Institute ENSTBB of Bordeaux, France (ENSTBB). In her current role, Amelie determines the go-to-market strategy for the Viral-based Therapeutics segment, covering both vaccine and gene therapies. Her previous roles at Sartorius include Manager Vaccine Applications, Process Development Consultant, and Application Specialist for the Purification Technologies division.