Biotechnology and Biomanufacturing in the U.S.
Last September, President Biden announced an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. Biotechnology refers to technology that uses principles derived from biological systems, such as genetic engineering, while biomanufacturing involves using a biological system as a manufacturing host, for example, using microorganisms like yeast to produce various molecules in the food and pharmaceutical industry.
In recent years, there have been significant advances in fundamental biology research and bioengineering feats. For instance, advances in sequencing technology have enabled large-scale data gathering experiments to be routinely done, and the human genome can now be sequenced in under a day and for less than $1,000, compared to the $3 billion and 10 years it took to complete the Human Genome Project in the 1990s. Additionally, the discovery of CRISPR has opened the doors for quick and accurate genome engineering. These discoveries and advances in biology have set the stage for a biorevolution. Before the Executive Order, the biorevolution was already starting. According to a report by McKinsey, the biotech sector saw substantial growth in venture-capital funding, deals, and IPOs between 2019 and 2020 alone. However, there is still much more room for growth in the biotech and biomanufacturing space. There are key sectors outside of the health sciences that can interface with biomanufacturing in which biotech is still only a small player, such as climate. Additionally, many products can be produced using bio-based methods, including materials. Engineering biology also offers the ability to create robust supply chains and increase the resilience of our food and agriculture pipelines.
The Executive Order
The Executive Order broadly stated the purpose of the order, parties that would be involved, and high-level goals and topics that would be addressed through the Executive Order. Importantly, it outlined different government agencies that would be tasked with writing up key goals and milestones to achieve the lofty goals outlined in the executive order. Some of the key takeaways from the executive order focused on research & development capacity and policy surrounding regulation of these technologies.
For research and development, the order was focused on human health, energy, food and agriculture, and supply chains. Understandably, the scope of each of these categories was not fully fleshed out. Unfortunately, the language was uninspiring - perhaps a biproduct of the nature of the writing piece. I really hope that future reports by respective government agencies highlight the scope to which biomanufacturing can be used in each of these categories. For example, the food and agriculture category was primarily focused on protection of food sources and food quality. While they did acknowledge cultivating alternative food sources - the overall summary lacked excitement surrounding the sheer amount of innovations that can fall into this category alone. Despite the vagueness, the order acknowledged that in order to advance biotechnology and biomanufacturing there would need to be clear research priorities and an understanding of existing research and development landscapes.
For regulation and policies surrounding biotechnology, the order acknowledged the complexity of biotech regulation and the potential for complex and undefined regulation to be a bottle-neck in advancements. As part of this order, identifying areas of improvement within the regulatory landscape will be a priority.
Other focuses of the order included data sharing, biosafety, measuring the bioeconomy, threat assessment, workforce, and biobased product procurement.
Bold Goals for U.S. Biotechnology and Biomanufacturing
Following the Executive Order, the White House released a document titled Bold Goals for U.S. Biotechnology and Biomanufacturing in March 2023. Through the next several blog posts I will be taking a deep dive into the bold goals and themes outlined by the White House. The list of themes and goals are below:
1. Carbon-neutral transportation and stationary fuels - expanding renewable feedstock availability
- Expand feedstock availability
- Produce sustainable aviation fuels
- Develop other strategic fuels
2. Production of chemicals and materials from renewable biomass and intermediate feedstocks, also focus on circular economy
- Develop low-carbon-intensity chemicals and materials
- Spur a circular economy for materials
3. Development of climate-focused agriculture systems and plants - restorative and resilient, includes engineering plants
- Develop measurement tools for robust feedstock production systems
- Engineer better feedstock plants
- Engineer circular food protein production systems
4. CO2 removal
- Develop landscape-scale biotech solutions
- Enable biomass with carbon removal and storage
I am really excited to dive into each of these and outline companies already working in each of the spaces, existing regulatory policies (and hurdles), and what the future of these sectors look like!
References:
https://www.weforum.org/agenda/2021/12/how-to-fuel-the-biomanufacturing-revolution/
https://www.genome.gov/about-genomics/educational-resources/fact-sheets/human-genome-project
https://frontlinegenomics.com/a-history-of-sequencing
This essay was copy edited by ChatGPT
