This expansion follows the groundbreaking of a large-scale commercial drug product facility in Stein (CH), in another milestone for Lonza’s Drug Product Services (DPS) offering
The facility has been set up to manufacture tuberculosis testing cartridges
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
The new sterile filling line meets cGMP aseptic filling regulatory requirements
Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability
Yonghe as the CDMO partner will provide production process development and cGMP manufacturing services for Ablaze
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
The investment will enable the company to enter European markets as well as enhance margins in current markets
GMP-compliant documentation of all manufacturing steps for cell and gene therapies
Expanded capacity in Nansha, China will support mid-scale manufacturing to ensure a smooth transition between early-phase and large-scale commercial production
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