Samsung Biologics is building a fifth plant for novel treatment types, including cell and gene therapy and mRNA and DNA vaccines. The Korean CDMO recently won FDA clearance to help make GlaxoSmithKline and Vir Biotechnology's COVID-19 antibody drug amid a rise in demand. Fujifilm is buying a new cell therapy plant for $100 million. And more.
1. Samsung Biologics outlines mRNA ambitions as 'Super Plant' speeds toward completion
Just as Samsung Biologics is accelerating building its Plant 4, also known as “Super Plant,” the Korean CDMO has outlined ambitions for Plant 5. The new facility will focus on cell and gene therapies plus next-generation vaccines using mRNA, DNA and viral vectors. Separately, an mRNA vaccine drug substance manufacturing suite is expected to come online at an existing facility soon.
2. GlaxoSmithKline rushes to accelerate COVID-19 antibody output amid omicron-driven demand
Samsung Biologics is also helping GlaxoSmithKline and partner Vir Biotechnology ramp up supply of their COVID-19 antibody, Xevudy, just as rival drugs by Eli Lilly and Regeneron are losing their U.S. authorizations against the dominant omicron variant. The FDA on Dec. 30 cleared a Samsung site as a second manufacturing facility to make Xevudy.
3. Fujifilm’s cell therapy ambitions grow with $100M Atara plant buy
Fujifilm is buying a cell therapy plant from Atara Biotherapeutics for $100 million. The 90,000-square-foot facility in Thousand Oaks, California, is “readily expandable,” according to the company, and has the flexibility to produce clinical and commercial T-cell immunotherapies. Fujifilm already has a cell therapy production site in Texas and another under construction in Massachusetts.
4. FDA slaps Aurobindo with warning letter on API testing failures, repeated violations
Aurobindo Pharma has received another FDA warning letter. This time, the agency took issue with the Indian pharma’s Telangana, Hyderabad, facility for failing to adequately investigate batch failure of active pharmaceutical ingredients and not evaluating their effects on drug substances.
Nippon Shinyaku paid $30 million upfront for commercial rights to Capricor Therapeutics’ investigational Duchenne muscular dystrophy cell therapy, dubbed CAP-1002. The drug’s now heading into a phase 3 in about 70 patients, with enrollment to start “as soon as we can,” Capricor's CEO said.
6. MD Anderson inks deal to put Chinese cancer drugs through trials, starting with a PI3K inhibitor
Shanghai’s Yingli Pharma tapped MD Anderson Cancer Center to help run clinical trials for the biotech's oncology candidates in the U.S. Its lead candidate, PI3K inhibitor linperlisib, is in phase 3 in follicular lymphoma. MD Anderson will first help run a phase 2 trial of the drug in peripheral T-cell lymphoma.
7. China's mRNA COVID shot, by Walvax and Abogen, posts modest early showing (Bloomberg)
China’s Abogen Biosciences and Walvax Biotechnology reported some early data from an mRNA COVID-19 vaccine candidate. The shot, at an intermediate dose, doubled the level of neutralizing antibodies than those seen in people who had recovered from an infection, according to phase 1 results published in The Lancet Microbe. A large efficacy trial is close to reaching its enrollment target of 28,000 participants, a company official said, as cited by Reuters.
8. WuXi STA opens new sterile manufacturing line at Wuxi City site
WuXi STA rolled out a fully automatic sterile manufacturing line for parenteral formulation at its facility in the Chinese city of Wuxi. The line can produce 2 million units a year. A second sterile filling line is expected at the site in the third quarter.