Process Scale-up

We align process intent with equipment capability to deliver consistent results from engineering runs to GMP batches.

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Scale-up you can validate

We translate development knowledge into robust, repeatable manufacturing performance.

Process scale-up confirms that process parameters deliver consistent critical quality attributes at larger volumes. Groupe PARIMA defines critical process parameters, sets a practical control strategy, and documents a clear path to validation-ready manufacturing.

We turn development knowledge into scalable setpoints, in-process controls, and consistent performance at target volume.

From Development to Manufacturing

Groupe PARIMA combines formulation, analytics, and GMP execution to make technology transfer practical, traceable, and ready for manufacturing. 

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Critical scale drivers defined

We connect CQAs to CPPs to focus scale-up work on what truly controls product performance.

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Process fit & equipment

We scale laboratory development to commercial volumes by aligning equipment and process parameters to reproduce formulation performance.

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PARAMETER‑SETTING STUDIES

We use systematic trials to define operating ranges and prepare process parameters for repeatability at the intended scale.

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Control strategy inputs

We define in-process controls, sampling plan, and acceptance criteria aligned with GMP expectations.

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Transfer-ready documentation

We generate clear batch instructions and process rationale to support smooth tech transfer and validation execution.

From development to target volume

We translate development knowledge into equipment‑fit processing, defined CPPs, and scale‑up data that prepare processes for repeatability and validation planning.

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Clinical lot

We manufacture flexible clinical lots ranging from 2 to 4,000 L to support early‑phase studies and evolving formulation needs.

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Stability Studies

Stability studies generate data to support formulation optimization and enable progression to clinical and regulatory milestones.

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Exhibit Batch

Exhibit batches are produced at appropriate scales to support regulatory submissions and demonstrate formulation robustness.

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Engineering Lot

Engineering lots are used to refine equipment selection and process parameters in preparation for scale‑up and validation.

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Analytical Method

We transfer and qualify fit‑for‑purpose test methods with clear system suitability, sampling, and reporting expectations.

Resources

Explore practical guidance that supports technology transfer into GMP execution for non‑sterile drug products

Groupe PARIMA
How Drug Product Formulation Works: Topical, Oral, and Nasal Liquid and Semi-Solid Dosage Forms
Groupe PARIMA
How Early API Characterization Can Reduce Formulation and Scale-up Risks
Groupe PARIMA
Topical 101: A Guide to Complex Dermatology Formulation Development
Groupe PARIMA
How Drug Product Formulation Works: Topical, Oral, and Nasal Liquid and Semi-Solid Dosage Forms
Groupe PARIMA
How Early API Characterization Can Reduce Formulation and Scale-up Risks
Groupe PARIMA
Topical 101: A Guide to Complex Dermatology Formulation Development

Contact us

Prepare for GMP execution

Let’s scope your tech transfer and align process, methods, and documentation into execution-ready deliverables at Groupe PARIMA.