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
- Brochures
- English
- 28 Dec 2023
- 3.19 MB
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Agilent to Acquire North American CDMO BIOVECTRA
Agilent Technologies signed a definitive agreement to acquire BIOVECTRA, a leading specialized contract development and manufacturing organization, for $925 million. Based in Canada, BIOVECTRA produces biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics. This expands Agilent’s end-to-end biopharma solutions that accelerate drug discovery, development, and manufacturing.
- Agilent to Acquire North American CDMO BIOVECTRA
- 22 Jul 2024
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