Opportunities in Synthetic Biology

Luina Bio is a Brisbane-headquartered biopharmaceutical contract manufacturing organization (CMO) that develops, implements and scales up production to deliver biologic medicines for patients in partnership with pharmaceutical and biotechnology companies. Through its 20 years’ experience, Luina Bio has provided development and production services to clients based in America, Asia, Europe and Australia. Its clients include biopharmaceutical development companies, research institutes, veterinary drug companies and universities.
 
Luina Bio offers a full-service range of manufacturing solutions for biological drugs and vaccines: GMP cell banking, multiple fermentation and downstream purification technologies both in development and GMP. It positions itself in a niche area of biopharmaceutical manufacturing with its core capabilities in manufacturing recombinant proteins, live biotherapeutics, nucleic acids and vaccines by microbial fermentation.
 
“The last 12 months have seen Luina Bio increase sales by 50% year on year, personnel numbers increased by nearly 40% and we have brought in 24 hour/5-day operations to better accommodate our customers,” says Les Tillack, CEO of Luina Bio. “We have also started a number of new projects with new customers and have an interesting pipeline of extremely innovative projects.”
 
According to Tillack, the biopharmaceutical development and manufacturing market is expanding at the moment. He says there are several factors contributing to this expansion, including the growth in large molecule based biological drugs; the coming of age of cell and gene therapies; the microbiome revolution which, although still in its infancy, has the potential of creating a market at least as important as that for large molecules; and the sudden interest in vaccines due to the COVID -19 pandemic. The most significant factor, Tillack says, is the rise of synthetic biology which potentially will overshadow all of the other factors.
 
“The potential of synthetic biology is the major factor that can drive the outsourced manufacturing market to a new level. The use of microbes to produce all kind of products and services—from water purification to textiles to pharmaceutical molecules—is only now being fully understood and its supply side economic implications are not entirely grasped yet,” Tillack explains.

What is Synthetic Biology?

Synthetic biology, or ‘synbio,’ is a rapidly emerging interdisciplinary science which seeks to apply engineering principles to biology. The aim is to develop DNA-encoded biological parts that are modular, behave reproducibly, and can be reliably assembled to build complex biological devices and even whole organisms.
 
“Synbio is a convergence of biotechnology, genetic engineering, information technology, and manufacturing,” says Tillack. “It also draws from a wide variety of other disciplines, such as systems biology, chemistry, computer engineering, evolutionary biology, physics, artificial intelligence and machine learning.”
 
Synbio processes include design and construction of physical componentry, in vitro and in vivo assembly of components to make genetic circuitry and biological devices, testing of those devices; and ultimately development of advanced engineered organisms.
 
Tillack says, “Synbio is fundamentally applied in that the aim is to achieve a useful outcome that solves a problem. Within the past two decades, the synthetic biology approach has produced several notable successes, especially in microbial systems. These include, for example, the design of a minimal bacterial genome (Hutchison et al., 2016) and a highly modified yeast genome (Richardson et al., 2017), as well as the metabolic engineering of yeast for the biosynthesis of the antimalarial drug precursor artemisinic acid (Ro et al., 2006).”

Addressing Obstacles

Synthetic Biology’s benefits are impressive, but the approach does come with some challenges. Namely, Tillack says implementing synthetic biology requires expanded capabilities and skill development. “Capacity for this work is already being put in place, but the availability of skilled personnel is limited and will need to grow sensibly in the near to medium term to satisfy a projected growth in demand.”
 
To address these obstacles, Luina Bio has plans for several expansions to meet the increasing demand in the microbiome and recombinant biopharma markets. The first stage of the expansion will see Luina open additional small scale (30L) GMP manufacturing suite in late 2020, broadening the company’s service offering for new clinical projects that need small scale GMP facilities. This is relevant to both personalized medicine and synthetic biology projects.  Tillack says this facility has already generated interest from Luina Bio clients.
 
This will be followed by the opening of four additional development laboratories in late 2020,
allowing Luina to take customer projects from the earliest development stage to a volume of
500L.
 
“This facility will allow us to accelerate development for our customers, thereby sensibly cutting their time to market,” Tillack remarks.

New Large-scale GMP Facility

Currently in planning, the next stage will see Luina develop a 10,000 square meter late phase clinical and commercial production facility for commissioning in late 2021. The new facility will have up to five production lines in parallel, ensuring that multiple-strain live biotherapeutics projects have compressed production times. Luina’s largest reactors (2,000L) will allow it to deliver live biotherapeutics volumes compatible with the commercial needs of those companies that have single-strain projects. The facility will also boast new technologies to decrease the downstream processing time of live biotherapeutics and bacterial recombinant biotherapy projects dramatically.

Looking Forward

Tillack predicts the synthetic biology market will split into at least two parts. “On one side we will have low volume, very high value production for the pharmaceutical industry with microbes engineered to produce drugs or prodrugs in an exquisitely specific fashion. This will allow precision medicine to develop in unbelievable new ways,” he says. “The other side will be the microbial production of all kinds of everyday goods from silk to microbes for digesting polluting plastics that will be produced in very high volumes at potentially low prices. A good equivalence will be the market for industrial enzymes and medical proteins which have similar characteristics.”
 
Whatever may unfold in the synthetic biology space as it develops, Luina Bio is prepared.
 
“Luina Bio has over 20 years’ experience in developing and manufacturing biologics in a vast array of bacteria and yeast,” Tillack concludes. “We are therefore able to understand what is needed in turning an academic or very experimental process into a robust, productive and reliable industrial production process.”

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