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October 06-08, 2026
Milan, Lombardy, ItalyProcess Scale-up
We align process requirements with equipment capabilities to support consistent performance from engineering runs through GMP manufacturing.
Scale-up built for validation
We translate development knowledge into robust, repeatable manufacturing processes designed to support successful process validation.
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 commercial scale.
From Development to Manufacturing
Groupe PARIMA combines formulation, analytics, and GMP execution to make technology transfer practical, traceable, and ready for manufacturing.
Critical Process Parameters 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.
VALIDATION-READY DOCUMENTATION
We develop clear batch instructions and process rationale to support consistent GMP execution and efficient process validation.
From development to target scale
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 develop and validate fit‑for‑purpose test methods with defined system suitability, sampling, and reporting expectations.
Ressources
Explore practical guidance that supports technology transfer into GMP execution for non‑sterile drug products