Quality Assurance, Quality Control, and Regulatory Support
Achieve high quality. Navigate regulatory compliance with confidence.
Agilent Advanced Therapeutics provides comprehensive quality and regulatory support that spans biologics, nucleic acids, small molecules, highly potent active pharmaceutical ingredients (HPAPIs), and other advanced modalities.
Our unified, International Council for Harmonisation (ICH)-aligned quality system and International Organization for Standardization (ISO)-certified, cGMP facilities are backed by a strong track record of FDA and global regulatory inspections. We deliver rigorous QA/QC, validated processes, and complete documentation packages to streamline submissions, reduce risk, and guide programs confidently from early development through commercialization.
Proven regulatory track record—Manufacturing aligns with global cGMP standards with regular inspections.
Global market authorizations—Seven approved oligonucleotide drug substances across major regions.
cGMP-compliant facilities—ISO-certified sites operating under ICH Q7 and cGMP standards.
Integrated QA/QC systems—Comprehensive testing ensures identity, purity, and potency for every batch.
Inspection-ready culture—Continuous improvement and documentation keep sites audit-ready.
End-to-end quality management—Rigorous oversight from raw materials to final API release.
Quality Assurance, Quality Control, and Regulatory Support
Partner with us for quality assurance, quality control, and regulatory support for high purity and global commercialization
Achieve high quality. Navigate regulatory compliance with confidence.
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Literature and resources
Browse brochures, flyers, and technical overviews to support your clinic‑to‑market journey
Advance oligo therapeutics from clinic to market
Produce high-quality oligo APIs according to cGMP standards, with regulatory support, global market expertise, and scalable solutions—from grams to kilograms.
in US and Canada are equipped for multiple modalities and projects
$1.65 billion
invested into CDMO business in 2023-2026
100+ successful audits
by pharma, biotech, and global regulatory agencies
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Watch on‑demand: capabilities, processes, and expertise
Explore videos, on-demand webinars, and conference talks recordings featuring expert insights and educational sessions.
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Browse the latest news on Advanced Therapeutics manufacturing
BIOVECTRA Is Honored with 2025 CDMO Leadership Award
BIOVECTRA, a part of Agilent Technologies Inc., proudly announces it is the recipient of the 2025 Outsourced Pharma CDMO Leadership Award in the category of biologics. The award recognizes BIOVECTRA’s performance in key areas such as quality, reliability, and technical capability.
3/6/2025
Agilent Completes Acquisition of BIOVECTRA
Agilent Technologies announced the company has completed its acquisition of BIOVECTRA, a Canada-based contract development and manufacturing organization (CDMO) that specializes in biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics.
9/20/2024
Agilent Investing $725 Million to Expand Nucleic Acid-Based Therapeutics Manufacturing
Agilent Technologies is investing approximately $725 million to double manufacturing capacity of therapeutic nucleic acids in response to rapid growth of the $1 billion market and strong demand for the company’s high-quality active pharmaceutical ingredients (APIs).
1/10/2023
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Innovative sustainability in water, waste, and energy
The Frederick facility integrates sustainable practices, like closed-cell cooling towers and reverse osmosis systems that save over 16 million gallons of water annually. A solar photovoltaic array generates 500 MWh of clean energy to offset utility demand. Waste reduction initiatives include acetonitrile recovery and destruction of dilute organics.
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