Synthetic biology, or synbio, is based on the idea that living cells can be engineered in a certain way — and it has potential applications in a vast number of areas, including health, packaging, and food.
Chantelle Kiernan, a senior scientific advisor for innovation at IDA Ireland, the country’s development agency, says that synbio has a number of different use cases. “In its purest form, what everyone’s aspiring to is to be able to take that [genetic] code that’s available, but in nature, and pick and play from it and develop an entirely new code that gives us something completely new and entirely different,” she adds.
In medicine, creating new drugs or “rewiring” cells to address diseases is still a long way off, but it’s a growing topic of interest within Ireland. “What we are seeing, and especially in the last year, is steps towards that, especially around ATMPs and cell and gene therapies,” Kiernan says.
ATMPs, or advanced therapy medicinal products, are groundbreaking drugs in three main categories: gene therapy, where a lab-created stretch of DNA is injected into a patient; somatic-cell therapy medicines, which include using cells or tissues that have had their biological makeup changed; and tissue-engineered medicines, where cells are modified so they can replace human tissue.
One recent breakthrough is the gene therapy treatment of a hemophilia patient at St James’ Hospital in Dublin. Another is a Biogen-sponsored clinical trial for motor neuron disease that included its first Irish patient in September, using a novel gene therapy, at the same hospital.
Synbio advances in Ireland
Ireland has not only a strong history of manufacturing in areas such as pharmaceuticals and biotechnology, but it also has a robust and growing research base. The €57 million National Institute for Bioprocessing Research and Training (NIBRT) opened in Dublin more than a decade ago and has since created training partnerships in China, the US, and with Japanese pharma company Takeda.
NIBRT is set to help position Ireland at the forefront of cell and gene therapy development and will expand into newly constructed facilities in 2022, increasing its capacity for courses and research.
Almost all of the world’s top pharmaceutical companies have operations in Ireland, and between 2009 and 2020 the country won more than €10 billion in foreign direct investment in the biopharma area — and now has more than 25 manufacturing sites.
The cell and gene therapies sector is expecting a global “manufacturing crunch” around 2024, according to Kiernan. “The FDA expects 10 to 20 ATMPs to be approved each year,” she says. “It’s a very specialist skill set … and if all that comes to fruition it’s likely there will be a manufacturing crunch in terms of capacity requirements.”
This is an opportunity for Ireland, which has a coordinated approach to delivering additional capacity, Kiernan adds. In February, Takeda announced a €36 million extension of its Grange Castle plant in Dublin, including the expansion of its cell therapy production line, the first such facility in Ireland. Meanwhile, MeiraGTx, a NASDAQ-listed early-stage gene therapy developer, announced in August that it would expand its facilities in Shannon, with its plant expected to be operational by the end of 2021.
Other use cases for synbio
Synbio is being applied in other areas, too. Kevin O’Connor, a professor at University College Dublin’s school of biomolecular and biomedical science, is the founder of Bioplastech, a company that develops biodegradable plastic using microorganisms – or bacteria. O’Connor and his team work with natural microorganisms in the environment and look at the optimal conditions for them, such as in the process of fermentation. A synthetic biology process can be applied when the bacteria reach their limit, he says. “Then we say, OK, let’s start to maybe knock out some genes, maybe put in some genes to make them fitter,” he adds.
O’Connor is also a director of BiOrbic, Ireland’s national bioeconomy Science foundation-funded research center. BiOrbic is part of a team using synbio techniques to “make the bugs even better,” at breaking down plastic and making new products. It is also in a partnership called Mix-Up, a collaboration of European and Chinese organizations aiming to find new ways to break down plastic and upcycle it into a biodegradable form.
“We’re looking at waste plastic and saying OK, how do we synthetically [enable] these microorganisms to … not only produce but be able to degrade waste plastics and mixtures of waste as well?” O’Connor says.
In addition to the plastics project, O’Connor’s team has worked on creating an organism via synbio that makes hydroxytyrosol — a key active ingredient in olives — through fermentation. Hydroxytyrosol is known to reduce cholesterol and prevent fats building up in the arteries and O’Connor’s product has been approved by the FDA, and patented in Europe and the US. For him, synbio can be used to better society.
“Like the biodegradable plastics, I want to produce things that are really going to benefit society,” he says. “I really love science, I like synthetic biology and I think if we can use bugs for our benefit, then that’s what we should be doing,” he says.