Process Scale-Up
We align process intent with equipment capability to deliver consistent results from
engineering runs to GMP batches.
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.
From development to Manufacturing
Groupe PARIMA combines formulation, analytics, and GMP execution to make technology transfer practical, traceable, and ready for manufacturing.
Scale drivers Precisely defined
We connect CQAs to CPPs to focus scale-up work on what truly controls product performance.
PROCESS FIT & EQUIPMENT
We scale laboratory development to commercial volumes by aligning equipment and process parameters to reproduce formulation performance.
PARAMETER‑SETTING STUDIES
We use systematic trials to define operating ranges and prepare process parameters for repeatability at the intended scale.
Control strategy INPUTS
We define in-process controls, sampling plan, and acceptance criteria aligned with GMP expectations.
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.
01
Clinical Lot
We manufacture flexible clinical lots ranging from 2 to 4,000 L to support early‑phase studies and evolving formulation needs.
02
Stability Studies
Stability studies generate data to support formulation optimization and enable progression to clinical and regulatory milestones.
03
Exhibit Batch
Exhibit batches are produced at appropriate scales to support regulatory submissions and demonstrate formulation robustness.
04
Engineering Lot
Engineering lots are used to refine equipment selection and process parameters in preparation for scale‑up and validation.
05
Analytical Method
We transfer and qualify fit‑for‑purpose test methods with clear system suitability, sampling, and reporting expectations.
We turn development knowledge into scalable setpoints, in-process controls, and consistent performance at target volume.
Resources
Access scale-up guidance designed for teams moving from development into controlled manufacturing performance.
Groupe PARIMA
How Drug Product Formulation Works: Topical, Oral, and Nasal Liquid and Semi-Solid Dosage Forms
Groupe PARIMA
How Drug Product Formulation Works: Topical, Oral, and Nasal Liquid and Semi-Solid Dosage Forms
Contact us
Plan your scale-up path.
Discuss your scale-up goals, target batch size, and critical process parameters with our technical team.