Luina Bio is a Brisbane-headquartered biopharmaceutical contract manufacturing group (CMO) that develops, implements and scales up manufacturing to ship biologic medicines for sufferers in partnership with pharmaceutical and biotechnology firms. By way of its 20 years’ expertise, Luina Bio has offered growth and manufacturing providers to purchasers primarily based in America, Asia, Europe and Australia. Its purchasers embody biopharmaceutical growth firms, analysis institutes, veterinary drug firms and universities.
Luina Bio provides a full-service vary of producing options for organic medication and vaccines: GMP cell banking, a number of fermentation and downstream purification applied sciences each in growth and GMP. It positions itself in a distinct segment space of biopharmaceutical manufacturing with its core capabilities in manufacturing recombinant proteins, dwell biotherapeutics, nucleic acids and vaccines by microbial fermentation.
“The final 12 months have seen Luina Bio enhance gross sales by 50% 12 months on 12 months, personnel numbers elevated by almost 40% and we’ve introduced in 24 hour/5-day operations to higher accommodate our clients,” says Les Tillack, CEO of Luina Bio. “We’ve got additionally began numerous new tasks with new clients and have an attention-grabbing pipeline of extraordinarily revolutionary tasks.”
In line with Tillack, the biopharmaceutical growth and manufacturing market is increasing for the time being. He says there are a number of elements contributing to this growth, together with the expansion in giant molecule primarily based organic medication; the approaching of age of cell and gene therapies; the microbiome revolution which, though nonetheless in its infancy, has the potential of making a market no less than as necessary as that for big molecules; and the sudden curiosity in vaccines as a result of COVID -19 pandemic. Probably the most vital issue, Tillack says, is the rise of artificial biology which doubtlessly will overshadow all the different elements.
“The potential of artificial biology is the key issue that may drive the outsourced manufacturing market to a brand new degree. The usage of microbes to supply all form of services and products—from water purification to textiles to pharmaceutical molecules—is just now being absolutely understood and its provide facet financial implications usually are not totally grasped but,” Tillack explains.
Artificial biology, or ‘synbio,’ is a quickly rising interdisciplinary science which seeks to use engineering rules to biology. The intention is to develop DNA-encoded organic elements which can be modular, behave reproducibly, and might be reliably assembled to construct complicated organic units and even complete organisms.
“Synbio is a convergence of biotechnology, genetic engineering, info expertise, and manufacturing,” says Tillack. “It additionally attracts from all kinds of different disciplines, resembling techniques biology, chemistry, pc engineering, evolutionary biology, physics, synthetic intelligence and machine studying.”
Synbio processes embody design and building of bodily componentry, in vitro and in vivo meeting of elements to make genetic circuitry and organic units, testing of these units; and finally growth of superior engineered organisms.
Tillack says, “Synbio is basically utilized in that the intention is to realize a helpful consequence that solves an issue. Inside the previous 20 years, the artificial biology method has produced a number of notable successes, particularly in microbial techniques. These embody, for instance, the design of a minimal bacterial genome (Hutchison et al., 2016) and a extremely modified yeast genome (Richardson et al., 2017), in addition to the metabolic engineering of yeast for the biosynthesis of the antimalarial drug precursor artemisinic acid (Ro et al., 2006).”
Artificial Biology’s advantages are spectacular, however the method does include some challenges. Specifically, Tillack says implementing artificial biology requires expanded capabilities and talent growth. “Capability for this work is already being put in place, however the availability of expert personnel is restricted and might want to develop sensibly within the close to to medium time period to fulfill a projected development in demand.”
To deal with these obstacles, Luina Bio has plans for a number of expansions to satisfy the rising demand within the microbiome and recombinant biopharma markets. The primary stage of the growth will see Luina open further small scale (30L) GMP manufacturing suite in late 2020, broadening the corporate’s service providing for brand new scientific tasks that want small scale GMP services. That is related to each customized medication and artificial biology tasks. Tillack says this facility has already generated curiosity from Luina Bio purchasers.
This can be adopted by the opening of 4 further growth laboratories in late 2020,
permitting Luina to take buyer tasks from the earliest growth stage to a quantity of
“This facility will permit us to speed up growth for our clients, thereby sensibly reducing their time to market,” Tillack remarks.
At present in planning, the following stage will see Luina develop a ten,000 sq. meter late section scientific and industrial manufacturing facility for commissioning in late 2021. The brand new facility can have as much as 5 manufacturing traces in parallel, guaranteeing that multiple-strain dwell biotherapeutics tasks have compressed manufacturing instances. Luina’s largest reactors (2,000L) will permit it to ship dwell biotherapeutics volumes appropriate with the industrial wants of these firms which have single-strain tasks. The ability will even boast new applied sciences to lower the downstream processing time of dwell biotherapeutics and bacterial recombinant biotherapy tasks dramatically.
Tillack predicts the artificial biology market will cut up into no less than two elements. “On one facet we can have low quantity, very excessive worth manufacturing for the pharmaceutical trade with microbes engineered to supply medication or prodrugs in an exquisitely particular vogue. It will permit precision medication to develop in unbelievable new methods,” he says. “The opposite facet would be the microbial manufacturing of every kind of on a regular basis items from silk to microbes for digesting polluting plastics that can be produced in very excessive volumes at doubtlessly low costs. equivalence would be the marketplace for industrial enzymes and medical proteins which have related traits.”
No matter could unfold within the artificial biology area because it develops, Luina Bio is ready.
“Luina Bio has over 20 years’ expertise in growing and manufacturing biologics in an unlimited array of micro organism and yeast,” Tillack concludes. “We’re due to this fact in a position to perceive what is required in turning an instructional or very experimental course of into a strong, productive and dependable industrial manufacturing course of.”