Seattle Children's collaboration to dive into cell therapy manufacturing; After success in court, Teva found guilty in NY
A cell and gene therapy company is extending its collaboration with Seattle Children’s Hospital to establish manufacturing practices for cell therapy, the company announced Tuesday.
BioLife’s new lentiviral vector manufacturing site, dubbed VectorWorks, will be used to find best practices in biopreservation and closed-system manufacturing with the introduction and integration of Sexton’s AF-500. Seattle Children’s, and its subsidiary Seattle Children’s Therapeutics, have used BioLife’s CryoStar for freezing media for several years in clinical applications and trials to improve the post-thaw viability and recovery of cells.
“This expanded collaboration is an exciting step for Seattle Children’s Therapeutics as we work towards developing closed-system processes for cell therapy manufacturing,” said Matt Selley, director of GMP manufacturing for Seattle Children’s. “Lentiviral vector manufacturing is a critical component of the cell production process.”
The collaboration will combine AF-500 with Seattle Children’s manufacturing expertise. AF-500 can fill and seal up to 560 vials in 90 minutes, the company says. The CellSeal Connect, which builds upon the technology used for the original CellSeal cryogenic storage vials, allows for a closed-system retrieval of viral vectors.
After big wins in court, Teva found guilty in NY
Drug manufacturer Teva Pharmaceuticals was found guilty by a New York jury for creating a public nuisance by manufacturing opioid pills that have killed thousands of people across the state, and what the CDC estimates are more than 600,000 people across the country.
The manufacturer released a press release stating that it “strongly disagrees” with the outcome, and is preparing an appeal, as well as pursuing a mistrial.
“In NY, the plaintiffs presented no evidence of medically unnecessary prescriptions, suspicious or diverted orders, no evidence of oversupply by the defendants – or any indication of what volumes were appropriate – and no causal relationship between Teva’s conduct including its marketing and any harm to the public in the state,” the statement said.
In November, Teva was found not guilty in California by Orange County, Los Angeles County, the City of Oakland, and Santa Clara County on grounds that it caused a public nuisance. A superior court judge in California ruled that opioid manufacturers were not responsible for the crisis because of their misleading marketing. The municipalities sought $50 billion in damages from J&J, AbbVie, Endo and Teva.
Meanwhile in Oklahoma, the state’s Supreme Court overturned an early ruling, stating that the public nuisance law in Oklahoma doesn’t extend to manufacturing, marketing and selling prescription opioids.
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