GreenLight Biosciences celebrates manufacturing milestone for Covid-19 booster candidate
It was late last year when the biotech GreenLight Biosciences inked a deal with CDMO giant Samsung Biologics to manufacture its mRNA Covid-19 vaccine. Now, as Samsung pumps more money into its biotech and CDMO operations, the South Korean company has completed the first commercial-scale engineering run for GreenLight’s Covid-19 vaccine booster candidate.
According to Samsung Biologics, GreenLight’s synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA. On the back of this test, GreenLight’s Covid booster is expected to have data later this year, with manufacturing at a commercial scale starting soon after.
In an interview with Endpoints News, GreenLight CEO Andrey Zarur said the company can iterate its mRNA platform to produce hundreds of mRNA species. That’s been beneficial in its original agricultural business and is now being applied to its vaccine candidate. Zarur said the platform allows the company to adjust and update the vaccine instead of sticking with a certain spike protein.
“The beauty of our platform is that once we have that we have ensured that whatever the leading candidate is that we liked at that microscopic scale is fully scalable to produce hundreds of millions of doses very rapidly,” he aid. “So, the value of the manufacturing platform itself gets amplified, if you will, by the fact that we have this upstream discovery engine.”
As for the first engineering run, Zarur said it went exactly as planned, adding that the company now has a high-productivity process that can run at a microgram scale, a gram scale, a 10-gram scale, and now a multi-100-gram scale.
The overall technology transfer and scale-up from the lab to Samsung’s commercial facility were completed in seven months, but according to Zarur, GreenLight’s management team has worked with Samsung for years — and that lasting collaboration was key in getting the process up and running.
“We are in conversations with several other companies in terms of others using our platform to manufacture their product. In terms of our partner for large scale clinical and commercial, right now we’re only talking to Samsung,” he said.
GreenLight also struck up other partnerships to create mRNA vaccines for other diseases. In March, the Serum Institute of India inked a deal with the biotech to jointly design three mRNA products, including a shingles vaccine, for development and eventual manufacturing and commercialization.
While the development of the booster continues, Zarur hopes to have a clinical study done by the end of the year and have data by early next year. Zarur also plans to work with regulatory bodies in Africa to start a clinical study on the continent as vaccination rates remain low.
“We are currently negotiating with a number of regulatory authorities in Africa to initiate those clinical studies in Africa. We have released a GMP batch and so we’re really just going through the details of the protocol,” he said.
As far as the future with Samsung, Zarur said they have discussed using the platform in different capacities, mainly to provide access to others who are designing novel mRNA approaches as well as provide greater scalability.