PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|February 22, 2023
Agilent Gains Design Support from CRB for Manufacturing Facility Expansion
Author(s)Pharmaceutical Technology Editors
Agilent’s therapeutic nucleic acids facility gains architectural design support from CRB.
Advertisement
CRB announced on Feb. 17, 2023 that it will be providing design support for Agilent’s manufacturing facility expansion in Frederick, Colo. The expansion will double Agilent’s manufacturing capacity of nucleic acid therapeutics.
Agilent’s two new manufacturing lines will help the company meet rapid growth within the nucleic acids market and strong demand for its APIs. CRB is working under Flour Corporation to deliver process design, process utilities, current good manufacturing practices architecture, and equipment procurement support for the facility’s new therapeutic nucleic acid manufacturing lines.
“Agilent’s facility will be a powerful tool in the effort to deliver these critical, life-saving therapies to patients,” said Jake Adams, senior project manager and RNA therapies market sector lead for CRB, in a company press release. “We are thrilled to help deliver Agilent’s difference-making solution.”
Source:
Advertisement
Related to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
AI can turn medical device risk management into a continuous signal.
Sanofi will transfer 20 mature medicines and three manufacturing sites to Cheplapharm for a 26.4% equity stake, closing by Q3 2027.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
Christy Owings, Thermo Fisher, on why early supply chain partnership and site visits prevent costly eCOA and clinical trial delays.
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
2
FDA's IND Pilot Puts CMC Review First
3
Spray Drying Capacity Signals Faster Paths for Poorly Soluble Drugs
4
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
5