GMP Cell Banking

Scientist with dropper in the lab preparing for cell bank generation

GMP master and working cell bank production and testing

  • Agilent Advanced Therapeutics provides GMP manufacturing of master cell banks (MCB) and working cell banks (WCB) for biologics, viral vectors, nucleic acids, and advanced therapeutics. Our controlled cleanroom environments, comprehensive QC testing, cryogenic storage systems, and harmonized quality system ensure consistent, traceable, and regulatory-aligned cell line production.
  • Cell bank production to GMP guidelines—Reliable MCB and WCB manufacturing in controlled suites which align with GMP standards.
  • Comprehensive characterization—Identity, purity, safety, and genetic stability testing in one workflow.
  • Integrated QC support—Aligned QC release and in-process testing for smooth progression.
  • Regulatory-ready documentation—Complete, audit-ready documentation for global submissions.
  • Seamless tech transfer—Efficient transfer from development into GMP manufacturing.

Cell Banking

Reliable GMP cell bank generation with automated vialing, comprehensive testing, and long-term storage.

Gloved technician placing sample tube into rack in a sterile lab environment for biologics testing and analysis.

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Features

Cell Banking to GMP Guidelines

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The Advanced Therapeutics advantage

50+ years of experience

in biopharma manufacturing

7 cGMP facilities

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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Specifications

Facility and equipment highlights

  • ISO 7/8 cleanroom environments
  • Grade C/D rooms for expansion and banking
  • Cryogenic vapor-phase LN2 storage
  • Real-time environmental monitoring
  • Secure storage and validated workflows

Capabilities and expertise

  • MCB/WCB production under GMP standards
  • Cell expansion and controlled-rate freezing
  • Identity, stability, and adventitious agent testing
  • Clone screening and lineage verification

Quality and compliance

  • ICH- and GMP-aligned systems
  • Strong inspection readiness
  • Comprehensive documentation for global filings
  • Comprehensive documentation for global filings
  • Secure chain-of-custody and traceability
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Browse other areas of expertise

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

Seamless transition from banked cells to protein production.

Consistent biologics manufacturing built on a stable bank.

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Circular biologics icon featuring an abstract DNA-like structure arranged in a ring. Microbial Fermentation

Direct scale-up of cell lines into fermentation runs.

Optimized workflows from strain banking to GMP-aligned batches.

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A dropper releasing a droplet above three capped test tubes in a rack, representing bioreagents sample preparation. Bioreagents

High-quality reagents to support bank creation and testing.

Reliable inputs for growth, viability, and characterization.

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Three small capped bottles with a dropper above the center one releasing a droplet into it, representing fill/finish. Fill/Finish

Final product filling for biologics produced from banked cells.

Maintains sterility and integrity through downstream steps.

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

Complementary CDMO support for small-molecule programs.

Unified vendor option for multimodality pipelines.

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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

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Frequently asked questions

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

What types of cell lines can you bank?

We support microbial, mammalian, insect, and engineered lines.

What tests are included in release?

Mycoplasma, sterility, identity, adventitious agents, endotoxin, viability, and stability data.

Do you create both MCB and WCB?

Yes, under harmonized GMP-aligned procedures.

How is storage managed?

Vapor‑phase LN2 freezers with monitoring, alarms, and redundancy.

Do you support regulatory submissions?

Yes, full documentation packages for IND, IMPD, BLA.

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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.
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Explore ways to connect with the Advanced Therapeutics team

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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.

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