GreenLight Biosciences celebrates manufacturing milestone for Covid-19 booster candidate – Endpoints News
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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.
The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.
Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.
The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.
Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.
Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.
Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.
The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.
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Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.
Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.
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Want a prescription drug with that soda? While not directly possible, ads for pharma brands now running on beverage and snack cooler screens at pharmacy retailers may at least inspire customers to think about it.
OptimizeRx is hooking up with Cooler Screens media company to bring prescription drug advertising to refrigerator front doors at pharmacies including Walgreens, CVS and Kroger.
The “point of dispense” ads show a full-door image on the cooler doors when a shopper is 12 feet away, but shrinks down to a smaller banner-sized ad so that the refrigerator contents can be seen when a person gets closer. The doors — which have to be specially installed by Cooler Screens — can detect when a person is nearby, how long a person “dwells” in front of the ad and if they do or don’t open the door.
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Senate Democrats may have all the votes they need to pass major drug pricing reform, after Sen. Kyrsten Sinema (D-AZ) reportedly pledged her support on Thursday — but will they fit it in before recess?
Sinema said she has agreed to “move forward” with the reconciliation bill with some stipulations, including the removal of a carried tax provision, according to recent reports. The bill is still expected to reduce the deficit by $300 billion, and Sen. Chuck Schumer (D-NY) said that he now anticipates “support from the entire Senate Democratic conference,” the Washington Post reported.
Add seniors’ advocate AARP to the list of groups pushing hard for proposed drug pricing legislation. The group’s most recent targeted TV ad campaign ends on Friday after airing on Washington, DC-area screens to push congressional representatives to act.
Its specific focus? “Put money back in the pockets of seniors” through the part of the bill that would allow Medicare to negotiate drug prices.
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A federal appeals court on Tuesday denied prosecutors’ attempt to lengthen the sentences of two former GSK scientists who pleaded guilty to stealing trade secrets.
Yu Xue and Tao Li pleaded guilty back in 2018 to conspiracy to steal trade secrets, after they, along with others, formed a pharmaceutical company in China called Renopharma using hundreds of stolen documents from GSK, according to court documents. Xue, a former top chemist at GSK’s Upper Merion, PA, facility, was accused of stealing more than 200 documents, some of which contained trade secrets about pharmaceutical products under development, research data, and development and manufacturing processes.
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August 5, 2022 at 11:36AM