Moderator: Dan Stanton, Co-founder and Editor, BioProcess Insider.
Featuring: Brian Finrow, Co-founder & CEO, Lumen Biosciences.
Although Chinese hamster ovary (CHO) cells remain the biopharmaceutical industry’s preferred expression system for antibody production, companies such as Lumen Biosciences are seeking out alternative hosts. Finrow cautioned that CHO cells sometimes complicate efforts to develop scalable and cost-effective manufacturing processes. For gastrointestinal (GI) indications such as Clostridium difficile infection and Crohn’s disease, spirulina, a biomass composed of cyanobacteria and their cellular by-products, could provide economical and highly scalable antibody production.
Spirulina is widely available as a food product, and its safety record is well established. Lumen seeks to produce therapeutic proteins using genetically modified cyanobacteria, then formulate the resulting spirulina into an oral presentation for topical application to GI mucosae. Alternatively, spirulina-based biologics could be formulated for intranasal, pulmonary, and even transdermal delivery.
Lumen’s approach holds several advantages over CHO-based applications, Finrow explained. CHO-sourced drug substances must undergo extensive purification and filtration in sterile operations to ensure that the resulting products are safe for parenteral administration. Mammalian cells also are susceptible to exhaustion in culture.
On the other hand, cyanobacteria proliferate easily in hydroponic tanks using only light, water, and nutrients. Because spirulina is safe for consumption, biologics that are derived from it and delivered orally require no chromatographic purification. Such factors, Finrow said, reduce up- and downstream costs significantly.
Finrow reported that his company’s facility, a retrofitted historic building in Seattle, WA, will be fully online in the summer of 2022. Therein, Lumen can perform sterile fermentation under good manufacturing practice (GMP) conditions. Currently, the company can produce 3 kg/week of GMP-grade drug substance, with capacity planned to produce
Finrow added that Lumen continues to seek out collaborators. The company already is working with Keon Pharmaceuticals and NovaNordisk. Because of those partnerships, Lumen’s pipeline and manufacturing process have matured significantly. Now, the company wishes to gain experience with those and new partners clinical trials, regulatory filings, and commercialization.
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