Monday, July 6, 2020 Daily Archives

The evolving demands of the temperature-controlled supply chain for cell and gene therapy

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As drugs have become more complex, so too has the supply chain, which must innovate to accommodate the necessary, specialized conditions for the storage and transportation of these drugs, even under extenuating circumstances. As the pharmaceutical industry shifts its attention to biologics and cell and gene therapies, the need for more advanced storage solutions has heightened considerably. In January 2019, former commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb, M.D. issued a statement regarding the impending cell…

July 6, 2020

Sarepta: ‘We have a voracious appetite for gene therapy manufacturing capacity’

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Inhouse capabilities coupled with capacity at CDMOs including Thermo Fisher and Catalent have allowed Sarepta Therapeutics to rapidly advance its gene therapy pipeline, says management. Sarepta Therapeutics has 43 programs in its pipeline, the majority of which are gene therapies and gene editing-based products. Leading gene therapy candidates include SRP-9001 Micro-dystrophin for Duchenne muscular dystrophy [DMD] and SRP-9003 for limb-girdle muscular dystrophy (LGMD). To support these developmental programs, the firm adopted two years ago what it calls “a hybrid manufacturing…

July 6, 2020

US FDA says platforms can speed COVID-19 jab development

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COVID-19 focused drug and vaccine firms need to keep a close eye on the US FDA according to lawyers who predict manufacturing and trial rules will continue to change. The US Food and Drug Administration (FDA) issued its latest guidance for firms developing vaccines against SARS-CoV-2 – the virus that causes COVID-19 – last week. The document sets out what trial data vaccine firms will need to supply. It also makes clear developers will have to seek approval the traditional…

July 6, 2020

Advanced therapy news: RoslinCT, Marker, Freeline to establish facilities

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As the surge in cell and gene therapies entering and progressing through the clinic continues, we highlight manufacturing plans from Marker Therapeutics, Freeline, and CDMO RoslinCT. First up in this cGMP manufacturing investment roundup is clinical-stage immuno-oncology company Marker Therapeutics, which has announced plans to lease a facility in Houston, Texas The 48,500 square-foot plant, expected to be operational in 2021, will support the firm’s T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. “We are…

July 6, 2020

Instant caRNA? Tesla touts RNA bioreactor it is developing with Curevac

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Curevac and car maker Tesla claim their development RNA production tech is less labour intensive and more deployable than alternatives. The technology – described as a Bioreactor for RNA in vitro Transcription – allows the DNA templates from which the RNA is produced to be used multiple times. It is also automated, which Curevac and Tesla say will minimize handling steps and make manufacturing processes more robust. The firms contrast their technology with current systems, which involve “many separate manufacturing…

July 6, 2020