Biopharmaceuticals and microalgae

At the service of the patient: scientific discoveries to be translated into industrial performance.

Biopharmaceuticals,
on the rise.

Incurable diseases may not be so tomorrow. From cancers to degenerative diseases, from rare diseases to certain chronic syndromes, innovative drugs could radically change the situation.

Biopharmaceuticals are a major opportunity for the pharmaceutical industry. Their active ingredient is made from living organisms. They include vaccines, gene therapies, recombinant proteins, monoclonal antibodies. They are the agents of choice in targeted therapies, especially in oncology, distinguishing themselves from the traditional cytotoxic chemotherapy.

On the current $1 trillion pharmaceutical market, biopharmaceuticals account for about 25%, a fraction that will grow to 50% within a decade. Their annual turnover is estimated at $800 billion by 2030.

Biopharmaceuticals,
unresolved issues.

Biodrugs are mainly produced by transgenic animal cell lines, as well as bacteria and yeasts.

The biopharmaceutical industry is facing new challenges: reducing production costs, accelerating commercialization and manufacture times, and reducing the risks of viral transmission from animal cells to humans.

The industry is also looking for new solutions to make biopharmaceuticals more stable and to develop alternative modes of administration (e.g. oral, avoiding parenteral injection).

To meet these challenges, a few pioneering companies have begun the bioproduction of recombinant proteins in plants.

Plant techniques have the advantage of high biosynthetic capacity, genetic flexibility, absence of human pathogens, all at a low cost.

Plants are easy to grow, produce large amounts of recombinant protein and are edible. Plant‑specific pathogens and viruses do not infect humans.

Nevertheless, the production of biodrugs by transgenic plants (leaves, tubers, seeds, fruits) is commercially limited because of the large land requirements, low surface productivity and expensive infrastructure needs. Indeed, the potential of contaminating the environment is a high risk and production is dependent on light availability.

Known companies in the production of biodrugs from transgenic higher plants are PlantForm, iBio Inc, Mapp Biopharma - LeafBio, Pfizer - Protalix, Ventria Bioscience, Medicago, Eleva Biologics, Kentucky BioProcessing, PhycoBiologics, Synthon, Fraunhofer, Healthgen, Planet Biotechnology, Denka-Icon Genetics (according to www.coherentmarketinsights.com). However, there have been some thundering failures, particularly with tobacco plants, because of the very great challenge of extrapolation to an industrial scale.

Microalgae,
an infinite reservoir of possibilities.

Our strategy centers on eukaryotic microalgae and their competitive advantages to produce ready‑to‑formulate active biodrugs. These tiny, photosynthetic unicellular microorganisms (<10 microns) have a fast growth rate, doubling their mass within hours, far exceeding that of any higher plant. Genetic transformation of their nucleus and chloroplast is accomplished using established methods, in accordance with regulatory guidelines. Intra- and inter‑lots uniformity of the active compound is guaranteed by the cellular homogeneity, as long as the rules of industrial extrapolation are strictly respected.

Growing in sunlight in nature, these chlorophyllic cells can be produced in artificially illuminated photobioreactors; some can also be grown on an organic carbon source in dark fermenters. The compactness of these closed production systems, preventing any risk of contamination and dispersion to the environment, is a decisive advantage over terrestrial plants.

Many microalgae are consumed as dietary supplements (Novel Food in Europe, GRAS in the USA). Their original cellular structure makes them suitable as effective vectors for oral, mucosal or topical delivery of biotherapeutic drugs.

Simplifications of the 'upstream' (USP) and 'downstream' (DSP) processes will lead to a significant reduction in production costs, by 1 to 2 orders of magnitude compared to the traditional techniques (animal cells, CHO, HEK, insect cells, ...)

(example of cultivation of microalgae by photosynthesis at the lab scale... that MUST be redesigned for pharmaceutical bioproduction)

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IASO BIOPRODUCTION SAS
Head office: 3 chemin des Balmes, F‑69110 Sainte‑Foy‑les‑Lyon (France)
Establishment (project): SkyeHub Skyepharma, 55 rue du Montmurier, F‑38070 Saint‑Quentin‑Fallavier (suburb of Lyon, France)