Agilent Advanced Therapeutics delivers end-to-end development and GMP manufacture of highly potent APIs (HPAPIs) with a focus on safety, precision, and scale. Our teams integrate deep process chemistry knowledge with purpose-built containment systems engineered for OELs <20 ng/m³, automated handling, and rigorous environmental controls.
From early process design and optimization through clinical and commercial supply, we streamline tech transfer, reduce risk, and ensure consistent, compliant production of complex HPAPI programs.
Find helpful answers to common questions as you evaluate and advance your program
What types of HPAPIs can Agilent Advanced Therapeutics manufacture?
Agilent Advanced Therapeutics supports a range of high potency APIs, including cytotoxic small molecules, ADC payloads and linker intermediates, and potent microbial metabolites, with processes designed for OELs below 20 ng/m³.
How does Agilent Advanced Therapeutics ensure operator safety in HPAPI manufacturing?
Safety is built into our facility and process design, with engineered containment, closed-system processing, industrial hygiene monitoring, and strict PPE and training requirements. Process automation and PAT limit manual interventions and improve consistency.
What scales do you support for HPAPI production?
We offer HPAPI manufacturing at pilot and commercial scales using 30–200 L reactor systems, allowing programs to move from clinical supply through commercial launch within the same network.
Can you support route development and optimization for new HPAPIs?
Yes. Our process chemistry teams work on route design, optimization, and scale-up for new HPAPIs, with a focus on safety, yield, robustness, and raw material control.
How do you support regulatory submissions for HPAPI programs?
We provide comprehensive documentation, including method validation reports, containment and hygiene data, batch records, and stability data to support INDs, NDAs, MAAs, and other regulatory filings.
Can HPAPI manufacturing be integrated with ADC or drug product activities?
Yes. HPAPI manufacture can be aligned with ADC payload and linker production, and with appropriate containment strategies, connected to downstream activities such as conjugation support and, where appropriate, fill/finish partners or internal capabilities.
style
id
faqs
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
id
news
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.
id
sustainability
Explore more ways to connect with our experts
Have questions or need a quote? Our manufacturing experts are here to help.
Get support from experienced specialists dedicated to your program’s success.
Upcoming events
See where the Agilent Advanced Therapeutics team will be next. Explore our upcoming conferences, tradeshows, and speaking engagements, and connect with us in person.
