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Process Development

Pharmaceutical process development services

Scale from bench to commercial GMP manufacturing with one team

Take animal health products from early feasibility and lab-scale batches through scale-up, validation, and commercial GMP manufacturing, all within one integrated organisation. No external transfers or partner changes required.

Talk to our process development scientists
GMP production room with extrusion and processing equipment used for pharmaceutical process development in animal health
Operator in cleanroom gown monitoring a process control panel during drug product process development and scale-up

Reach commercial scale with a process you can justify to regulators

Every scale-up decision is informed by manufacturability, regulatory requirements, and the data you’ll need for registration.

  • Use less API in your early batches: Feasibility studies and small-scale batches test process compatibility and evaluate release profiles while keeping your API requirements low.
  • Know which parameters matter: Process characterisation and critical process parameter identification at each scale give you the data to justify your process to regulators.
  • Scale without changing partners: Your process moves from non-GMP bench scale to GMP pilot scale to commercial GMP manufacturing, all within Argenta.
  • Validate with the data you’ll need: Process validation campaigns are designed to meet EMA, FDA, and VICH requirements, with informational data collected during GMP runs to support your specifications.
  • Protect your product with the right packaging: Packaging selection and development safeguard stability, ingredient compatibility, and regulatory compliance across global animal health markets.
Talk to our process development scientists

20+ process development scientists, engineers, and compliance leads

125+ commercial products manufactured

50+ countries supplied

Our Process Development Services

Get every stage of drug product process development from one team

From your first small-scale batch through to a validated commercial process, each stage builds on the data from the last.

Feasibility & small-scale batches

Test process compatibility and evaluate release profiles early using in-house small-scale batches to keep your API requirements low.

Pilot scale-up

Scale your lead formulation to around one-tenth of commercial scale and generate the data that justifies every critical process parameter.

Process characterisation & optimisation

Get consistent quality and manufacturability, with your process characterised and optimised at every scale.

Process validation

Meet EMA, FDA, and VICH requirements with validation programmes that capture informational data during GMP runs.

Packaging development

Choose packaging that protects stability, ensures ingredient compatibility, and meets regulatory requirements across global markets.

Technology transfer

Move your validated process into Argenta’s manufacturing sites, between our sites, or out to another partner.
Talk to our process development scientists

Scale to the capacity your market needs

Your process is developed and qualified at each scale it will run at, through to commercial supply.
Icon of test tubes for bench-scale feasibility batches

Bench

(non-GMP)

Feasibility, small-scale batches, and early process characterisation.

Icon of a test tube under a magnifying glass for GMP pilot scale-up

Pilot

(GMP, around one-tenth of commercial scale)

Scale-up, critical process parameter data, and batches for your field studies.

Icon of a warehouse and conveyor for commercial GMP manufacturing and supply

Commercial

(GMP)

Process validation and commercial supply, with capacity for 12 million litres of liquids, 400 tonnes of solid dose, and 20 million controlled-release capsules.

Take your product from molecule to market with integrated services

Early phase development

Your early-phase work runs alongside pilot, feasibility, and target-animal safety studies, so formulation data shapes your study design, and study results feed back into your formulation decisions.

Formulation development

Your regulatory team works alongside your formulation scientists from day one, so every formulation decision supports your submission.

Analytical development

Your analytical work spans product optimisation through registration, so the methods you develop early carry through to your dossier.

Process development

Your pilot and registration batches supply your field studies directly, so test articles never move between partners.

Why Argenta

Why choose Argenta for process development?

Keep one team from bench to commercial

Manufacturability, clinical needs, and regulatory requirements inform every process decision, which reduces rework and late-stage surprises.

Build for regulatory approval from day one

Our animal health regulatory team builds VICH-aligned CMC strategy into your process decisions from the earliest stages.

Benefit from what every campaign teaches us

When a campaign doesn’t go to plan, our team runs a postmortem, finds the root cause, and carries the improvements into future campaigns.

Related services

Clinical studies

Run your target animal effectiveness and field studies on product supplied directly from your scale-up and registration batches.
Learn more

Regulatory affairs

Turn your process data into one coordinated dossier, with our in-house regulatory team helping compile the CMC, safety, efficacy, and food safety sections.
Learn more

Contract manufacturing

Move your validated process into commercial GMP manufacturing, with capacity for 12 million litres of liquids, 400 tonnes of solid dose, and 20 million controlled-release capsules.
Learn more

Featured resources

Outsourced stability testing: Ensuring product quality and reliability

Download Whitepaper

Developing a palatable and effective soft chew for companion animal medicine

Download the eBook

Accelerating the path to market for microspheres

Download the eBook
Explore all resources

FAQs

What pharmaceutical process development services does Argenta offer?

Feasibility and small-scale batches, pilot scale-up, process characterisation and optimisation, process validation, packaging development, and technology transfer, all within one animal health organisation.

Can you take a project from early feasibility through commercial manufacturing?

Yes. Your formulation, process development, analytical development, clinical supply, process validation, and commercial manufacturing can all stay with Argenta.

What if we only need help with one stage of drug product process development?

You choose the scope. That can be a targeted feasibility study, a single scale-up or validation campaign, or full end-to-end support.

Can your pilot batches supply our field studies?

Yes. Your target animal effectiveness and field studies can be supplied directly from your scale-up and registration batches, so test articles never move between partners.

How does process development connect to technology transfer?

Once your process is validated, it can move into Argenta’s manufacturing sites, between our sites, or out to another partner, with our regulatory team answering authority queries while the receiving site is qualified.

Which regulatory bodies do you have experience with?

FDA CVM, EMA, APVMA, and EFSA. Our regulatory team designs VICH-aligned CMC strategies from the start of your development programme.

Healthy animals. Let’s make it happen, together.

Get a validated process that’s ready for commercial supply, developed by the team that will help you manufacture it.
Talk to our process development scientists