-black.png){kind=logo}
While Chinese hamster ovary (CHO) cells continue to be the favored expression system for antibody synthesis in the biopharmaceutical industry, organizations like Lumen Biosciences are looking for alternate hosts. Finrow issued a warning that efforts to create scalable and economical production processes can occasionally be complicated by CHO cells. Spirulina, a biomass made up of cyanobacteria and their cellular byproducts, could offer affordable and highly scalable antibody production for gastrointestinal (GI) indications such Clostridium difficile infection and Crohn's disease.
As a food product, spirulina is widely accessible, and its safety record is well known. Lumen's goal is to use genetically altered cyanobacteria to manufacture therapeutic proteins, then turn the resulting spirulina into an oral presentation for topically applying to GI mucosae. Alternative delivery methods include intranasal, pulmonary, and even transdermal for biologics based on spirulina.
Finrow said that compared to CHO-based applications, Lumen's approach had a number of benefits. To make sure the final products are safe for parenteral administration, CHO-sourced medicinal compounds must undergo thorough purification and filtration in sterile processes. In culture, mammalian cells can also become worn out.
The only resources needed for cyanobacteria to grow in hydroponic tanks are light, water, and nutrients. Spirulina is a safe food source, therefore oral delivery of biologics obtained from it does not necessitate chromatographic purification. According to Finrow, these elements greatly lower up- and downstream expenses.
We talked to Brian Finrow about more insights on the company’s success and he gave us quite everything we wanted to know. Take a look at the exciting journey of Lumen Bioscience.
Lumen Bioscience
The combination of four therapeutic proteins known as LMN-201 works synergistically to neutralize the virulence-causing toxin of the C. difficile bacterium as well as the bacterium itself in the patient's gastrointestinal tract. LMN-201 is made by Lumen in Seattle under GMP standards, is used orally (as capsules), and is compatible with commonly prescribed antibiotics. As commensal bacteria recolonize the GI tract, LMN-201 is meant to be used concurrently with standard antibiotics for eight weeks afterward to prevent reinfection.
According to Brian Finrow, co-founder and CEO of Lumen Bioscience, "Fast Track Designation highlights the tremendous unmet need for treating and preventing C. difficile infection and the potential for LMN-201 to close this ongoing gap in patient care. Recent improvements in CDI recurrence prevention are encouraging, but they haven't yet had a noticeable effect on the epidemic, largely because of the inconveniences associated with their administration. In order to relieve the suffering of people who are dealing with this potentially fatal illness, we are dedicated to developing our clinical program and getting this cutting-edge medicine to patients as soon as possible.
Q. How does Lumen's plant-based manufacturing work?
Extreme simplicity is what makes our goods so much more quickly scalable and reasonably priced than conventional technology. When a production run begins, the open-topped photobioreactors are filled with city water and a small amount of mineral salts. Photosynthetic cells just require a few things to thrive. High-intensity LED lights are used to illuminate the photobioreactors and supply the energy necessary for cell development. In order to keep pH within operational limits, CO2 is sparged, and air is sparged in order to prevent settling.
It took a lot of work a number of years ago to optimize the design of the bioreactor frame since it was a complicated issue. However, now that we have that optimal design, they are quite straightforward to construct and run, especially given that we use disposable plastic bags to make cleaning easier in between production campaigns.
Notably, sterility is not necessary for safety because spirulina is so resilient and the products are meant for oral ingestion. This aspect alone makes their business significantly less expensive than batch fermentation methods used in the past.
Q. How can the production of biologic drugs be scaled up, accelerated, and made more affordable using genetically modified spirulina?
Traditional injection biologics development, testing, and production are exorbitantly expensive and time-consuming, in part because injecting synthetic proteins into the bloodstream has inherent dangers.
Lumen, on the other hand, purposefully designed the entire product development environment to be straightforward and intrinsically secure. This begins with the fact that spirulina has a history of safety dating back hundreds of years in traditional societies, as well as 50 years in the US. Additionally, because they typically don't enter systemic circulation, mucosally administered biologic medications are fundamentally safer than their injectable equivalents.
This significantly reduces the chance of toxicities or off-target effects. Just contrast the space-age technologies, bunny-suit sterility, and exotic media components employed in the production of conventional CHO antibody medicines with our manufacturing approach (simple salt water in an open photobioreactor).
Q. What are Lumen’s future targets to develop low-cost biologic drugs?
It would be early to share more information at this time (and in some cases, we are restricted by confidentiality agreements), but when you take into account the fact that our platform enables the delivery of arbitrarily large amounts of biologic drug, frequently in cocktail formulation, to topical targets (G.I. mucosa, upper airway mucosa, skin, etc.), it becomes clear that there is a significant unmet medical need that our technology could assist in addressing.
Examples include autoimmune GI tract conditions like Crohn's disease, ulcerative colitis, celiac, etc. Metabolic conditions like diabetes and other imbalances, conditions caused by enzyme deficiencies like hyperketonemia and hepatic encephalopathy, and infectious conditions that spread through the upper respiratory tract like pandemic influenza.
Final Remarks
Lumen Bioscience finds, creates, and produces biologic therapeutic candidates for widespread illnesses, many of which are currently untreated. Through enhanced speed, mass-market size, and tenfold lower costs than current methodologies, the company's innovative medication research and manufacturing platform has the potential to completely change the biologics business. Investigational biologic medications for Covid-19, inflammatory bowel disease, C. difficile infection, norovirus, cardiometabolic disease, and traveler's diarrhea are part of Lumen's clinical pipeline.
