Part of a $40 billion U.S. investment, the Texas site will manufacture multiple medicines including antibody-drug conjugates, biologics, and small molecules.
In response, Scholar Rock will remove the Bloomington fill-finish facility from its Biologics License Application with the agency and rely on a third-party provider.
Court grants the China-headquartered CRDMO’s motion for preliminary injunction to enjoin Department of Defense from enforcing or implementing 1260H list designation.
The companies will add a 1,400-kg annual sterile active pharmaceutical ingredient suite in India as Gland also expands its CDMO work with a global pharmaceutical company.
The pilot program combined continuous-flow chemistry, real-time analytics, and AI-driven process control to produce and optimize pharmaceutical ingredients in a continuous process.
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