Late Stage and Commercial Development
The large-scale Agilent facility in Frederick produces multikilogram lots of oligo APIs for late-stage clinical trials and commercialization. To increase batch sizes and accommodate more programs, Agilent launched a second manufacturing train in 2023. Future expansion is additionally planned for 2027.
- Oligonucleotide GMP Manufacturing
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Product Details
- Agilent oligonucleotide manufacturing facilities in Boulder and Frederick have been regularly and successfully inspected by the U.S. Food & Drug Administration (FDA) since 2015
- Platform biotech and large pharmaceutical customers have performed more than 100 successful audits in both Agilent facilities
- Successful scale-up and cGMP manufacturing, demonstrated by several multikilogram campaigns with batches of up to 20 kg
- In-house analytical testing includes auto titration, coulometric water determination, endotoxin analysis, FTIR, GC, HPLC, and Karl Fischer water determination
- Additional in-house analytical assessment consists of metals analysis, nuclear magnetic resonance, osmolality, total organic carbon, transition melt analysis, ultraviolet spectroscopy, and viscosity determination
- Agilent experts transfer, develop, qualify, and validate analytical methods from investigational new drug (IND) to new drug application (NDA) and biologics license application (BLA)
- Analytical methods are developed, qualified, and validated for raw materials, in-process testing, release testing, and stability testing
- Agilent testing covers all aspects of the supply chain and manufacturing process, from raw materials through in-process testing and final release
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Accelerate Your Journey from Clinic to Market
Produce high-quality oligo APIs and efficiently advance from clinic to market, delivering therapeutics to patients with unmet medical needs
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- English
- 28 Dec 2023
- 3.19 MB
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TIDES Asia 2024
1 Awadaguchi Kachocho, Higashiyama Ward, Kyoto, Japan
Colorado Governor Polis Helps Agilent Break Ground on $725 Million Expansion of Manufacturing Operations in Frederick
Agilent leaders joined Colorado Governor Jared Polis and local government officials to break ground on $725 million investment to double manufacturing capacity of therapeutic nucleic acids in Frederick, Colorado. The investment will create more than 160 life science jobs in the area. Agilent’s manufacturing facilities in Colorado produce siRNA, antisense molecules, and CRISPR guide RNA molecules.
- 16 Feb 2023
Agilent Investing $725 Million to Expand State-of-the-Art Manufacturing Capacity for Production of Nucleic Acid-Based Therapeutics
Investment will double capacity to produce active pharmaceutical ingredients used in therapeutics for a broad range of diseases. The addition of two new manufacturing lines (known as Trains C and D) will enable Agilent to meet growing demand for siRNA, antisense and CRISPR guide RNA molecules. Agilent expects customer shipments from the expansion to begin in 2026.
- 05 Dec 2022