Fill/Finish Services

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Isolator-based aseptic filling for clinical and commercial drug products

  • Agilent Advanced Therapeutics provides GMP aseptic fill/finish using automated VanRx systems and single-use flow paths. With 10R and 2R vial formats, real-time monitoring, and QC integration, we ensure sterile and reproducible manufacturing.
  • Aseptic isolator filling—Isolator-based automation ensures consistent sterile processing.
  • Single-use fluid paths—Sterile, disposable paths minimize contamination risk.
  • 2R and 10R vial capability—Automated filling with in-line inspection for every vial size.
  • Clinical–commercial flexibility—Batch sizes scaled to fit early programs through launch.
  • Integrated QC oversight—Release testing and environmental monitoring in one workflow.
  • Smooth tech transfer—Efficient transfer from upstream into aseptic filling.

Fill/Finish Services

Isolator-based GMP fill/finish for liquid drug products with automated systems and reliable quality control.

A large enclosed filling and processing unit with viewing windows, control panels, and sealed access points inside a cleanroom.

Features

The Advanced Therapeutics advantage

50+ years' experience

in biopharma manufacturing

7 cGMP-aligned facilities

in U.S. and Canada are equipped for multiple modalities and projects

$1.65 billion

invested into CDMO business in 2023–2026

100+ successful audits

by platform biotech, big pharma, and global regulatory agencies

Specifications

Facility and equipment highlights

  • Cytiva SA25 and Microcell VanRx isolator systems
  • Single-use filling assemblies and closed-system automation
  • cGMP-grade C/D manufacturing suites
  • Integrated vial washing, filling, stoppering, and capping

Capabilities and expertise

  • Aseptic vial filling for biologics, mRNA/LNP, pDNA, and small molecules
  • In-process controls and automated fill-weight verification
  • Visual and automated inspection options
  • Container closure integrity testing (CCI)

Quality & compliance

  • Biologics, enzymes, recombinant proteins
  • mRNA, LNP formulations, plasmid DNA
  • Sterile small molecule injectables
  • Diagnostic reagent vialing
  • GMP-aligned aseptic processing
  • Environmental monitoring and particulate control
  • Full batch record documentation for clinical and commercial supply
  • Strong regulatory inspection readiness

Browse other areas of expertise

A cluster of connected circular nodes forming a branching structure, with a distinct end node, representing synthetic small molecules. Synthetic Small Molecules

Sterile filling support for liquid small-molecule products.

Smooth transfer from chemical manufacturing to final dosage.

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Protective gloves representing aseptic processing and GMP manufacturing practices. Highly Potent APIs

Contained processing for potent small-molecule APIs.

Safe, scalable pathways for high-potency compounds.

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A circular DNA-like loop of two intertwined strands with repeating paired segments, representing biologics. Biologics

Fill/finish for protein and enzyme therapeutics.

Maintains stability and integrity of sensitive biologics.

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A pipette dispensing a droplet into one of three test tubes held in a laboratory rack. Bioreagents

Direct path from upstream fermentation to vialed product.

Streamlined tech transfer for fermenter-derived materials.

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Frequently asked questions

Find helpful answers to common questions as you evaluate and advance your program

What vial formats do you support?

We fill 10R and 2R vials using automated VanRx isolators.

Do you support biologics and nucleic acids?

Yes, our systems handle liquid biologics, enzymes, mRNA/LNP, and pDNA.

How do you ensure sterility?

Closed-system isolators, single-use flow paths, environmental monitoring, and real-time QC controls.

Can you support clinical and commercial batches?

Yes, flexible batch sizes support early and late-stage programs.

Do you provide regulatory documentation?

Yes, comprehensive documentation is provided for IND and IMPD filings.

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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

Man with a long-sleeved blue shirt with Biovectra logo, purple gloves, and safety glasses works on a machine.

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’s Frederick, Colorado manufacturing facility extension with modern design and parking area.

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

Innovative sustainability in water, waste, and energy

Aerial view of the Frederick facility with multiple buildings and vents on the roof, with mountains under a blue sky.
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.

Explore ways to connect with the Advanced Therapeutics team

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