Manufacturing
The company is investing billions of dollars to construct a European biosimilar hub capable of supporting the rapid expansion of its portfolio.
Contract development and manufacturing organizations looking to do business with biopharmas include Lonza, which has more than 30 sites, and Samsung Biologics, which recently announced a planned acquisition of another CDMO.
After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.
A new program from ARPA-H has devoted funding to make individualized RNA-based genetic medicine more efficient to produce and improve accessibility.
Manufacturers are being pushed beyond mAb‑era platforms into a new design model built around molecular engineering, complex analytics and amplified upstream and downstream processing.
Vitruvias Therapeutics has “ceased operations” after voluntarily recalling a batch recall of generic thyroid tablets due to possible superpotency that could cause a range of adverse events.
Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist.
The talent pool not keeping pace with increased outsourcing demand is just one reason CDMOs have trouble filling roles, according to a search expert. He also told BioSpace who is most in demand and how candidates can stand out from the competition.
While Novartis’ Pluvicto is a blockbuster, Curium heads into talks with the FDA about the review of its rival drug candidate believing a competing product can make the supply chain more resilient.
After committing $2 billion to a new North Carolina facility to boost capacity for its next-gen obesity candidates, Roche’s Genentech is putting down more cash to expand a device fill-finish site in Oregon.
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