Wednesday, March 23, 2022 Daily Archives

Rolontis review: Spectrum confident manufacturing deficiencies resolved

Spectrum Pharmaceuticals has resubmitted the BLA for eflapegrastim following the remediation of manufacturing deficiencies at a drug substance facility in Korea. In August 2021, Spectrum received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its long-acting granulocyte-colony stimulating factor (G-CSF) agent Rolontis (eflapegrastim). The letter, which put a hold on Spectrum’s Biologics License Application (BLA) for eflapegrastim, identified manufacturing challenges. But during his firm’s fourth quarter 2021 financial call last week, CEO Tom Riga…

Californian CDMO triples iPS capacity with $10m investment

I Peace has invested over $10 million to expand its Palo Alto, California plant, tripling capacity to manufacture iPS and iPSC-derived differentiated cells. I Peace, a contract development manufacturing organization (CDMO) start-up, has tripled its capacity to produce induced pluripotent stem (iPS) cells and induced pluripotent stem cells (iPSC) by expanding its facility. The firm claims that the plant expansion will meet the demand for iPS cells from pharmaceutical companies and cell therapy manufacturers, as well as providing individuals with…