Synthetic Small Molecules

Scientists using microscope and lab equipment for synthetic small molecule research, analysis, and pharmaceutical development.

Safe, scalable, and compliant HPAPI manufacturing

  • Agilent Advanced Therapeutics delivers integrated development and manufacturing solutions for synthetic small molecules, including complex chemistries, intermediates, and HPAPIs.
  • Our capabilities span route design, process optimization, analytical development, scale-up, and cGMP production supported by advanced containment and harmonized, ICH-aligned quality systems. With proven regulatory experience, robust tech transfer, and end-to-end analytical and stability testing, we help reduce risk, improve reliability, and advance programs efficiently from early development through commercial supply.
  • End-to-end chemical development—Route scouting, optimization, impurity control, and scalable process design.
  • Large-scale commercial manufacturing—Flexible production from 1 kg to over 200 MT annually across multi-purpose suites.
  • Flow chemistry expertise—Enhanced safety, yield, and throughput for highly reactive or exothermic transformations.
  • Specialty chemistries—Lipid synthesis, PEGylation, linker chemistries for ADCs, and controlled substance manufacturing.
  • Advanced purification—High-capacity chromatographic purification, including 80 cm RP columns for commercial-scale polishing.
  • Integrated analytical support—Comprehensive method development, stability, impurity profiling, and regulatory documentation.

Synthetic Small Molecule Manufacturing

GMP synthesis of complex small molecules supported by advanced chemistry, analytics, and scalable production

Pipette adding liquid to vial in sterile lab setting, supporting biologics formulation and pharmaceutical development processes.

Features

Safe, scalable, and compliant HPAPI manufacturing.

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

  • Multipurpose GMP chemistry suites in Charlottetown, PEI, Canada
  • Production scale from 1 kg to 200 MT annually
  • Batch and flow chemistry capabilities
  • Temperature-controlled reactors with advanced safety controls
  • Large-scale purification including reverse-phase chromatography (up to 80 cm columns), crystallization, distillation, and solvent recovery
  • Handling capabilities for highly reactive chemistries, moisture-sensitive or oxygen-sensitive steps, controlled substances (licensed facility)
  • Integrated utilities and separate HVAC for segregation

Capabilities and expertise

  • Route design, scouting, and optimization
  • Safe, scalable processes with impurity mapping
  • Flow chemistry for improved safety and efficiency
  • PEGylation, lipid chemistry, polymer modifications
  • Linker and conjugation intermediate synthesis (ADC precursors)
  • Controlled substance manufacturing under strict regulatory oversight
  • Tech transfer from development to GMP manufacturing
  • In-process controls supported by PAT-based monitoring

Product applications

  • APIs and registered intermediates
  • Lipids for mRNA and LNP formulations
  • PEG linkers and polymer derivatives
  • ADC linkers and warhead intermediates
  • Small molecules for biologics conjugation
  • Controlled substances for clinical and commercial supply

Browse other areas of expertise

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

Support for potent compounds derived from microbial pathways.

Contained processing for high-potency fermentation outputs.

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Bioreactor vessel representing fermented small molecule production. Fermented Small Molecules

Microbial routes to key precursors or starting materials.

Cost-efficient production for complex or niche intermediates.

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

High-purity reagents to streamline HPAPI development workflows.

Reliable GMP-grade inputs for critical synthesis steps.

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

Parallel support for programs spanning small- and large-molecule modalities.

Unified CDMO pathways for hybrid or combination products.

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Dropper dispensing liquid into a vial, representing bioreagents sample preparation. Fill/Finish

Aseptic filling for potent small-molecule drug products.

Containment-ready systems for safe handling of HPAPI formulations.

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

Expanded capacity for larger batches or alternate host systems.

Flexible platforms for metabolites, enzymes, and intermediates.

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Frequently asked questions

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

What scales of synthetic small molecule manufacturing do you offer?

We support production from gram-scale development batches through commercial-scale manufacturing exceeding 200 MT annually, with multipurpose suites capable of handling complex chemistries and controlled substances.

Can Agilent Advanced Therapeutics develop and optimize new synthetic routes?

Yes. Our process chemistry teams specialize in route scouting, impurity mapping, and the design of safe, scalable, and efficient processes that transition smoothly from development into GMP manufacturing.

Do you support lipid, PEG, and linker chemistries for advanced therapeutics?

Absolutely. We manufacture high-purity lipids for mRNA and LNP formulations, PEG derivatives, and a range of ADC linker chemistries, including bifunctional linkers and polymer-based conjugation agents.

How do you manage highly reactive or hazardous chemistry?

Through flow chemistry, engineered safety controls, temperature-controlled reaction systems, and real-time monitoring. These approaches increase safety, yield, and scalability for exothermic or sensitive reactions.

Are your facilities licensed for controlled substances?

Yes. Our Charlottetown site is a licensed controlled-substance manufacturing facility, with secure handling, comprehensive documentation, and compliance with national and international regulations.

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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.

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