Riom 2

CARBOGEN AMCIS expands capacity for parenteral drug manufacturing

In France, on newly acquired land located 7 km from the existing site in Riom north of Clermont-Ferrand in Auvergne, construction have begun in January 2021 with a new, state-of-the-art facility dedicated to custom development and manufacturing of parenteral drug products.

This new state-of-the-art facility will allow for larger capacities to supply our customers with clinical batches for phase III clinical trials and small-scale for commercial. The handling of complex formulations will include a large range of APIs from biologics to highly potent compounds.

Operations will commence during Q1 of 2023.

Production Lines

	Line 1 – liquid & lyophilized form Vials	Line 2 – Fill & Finish Vials, Prefilled Syringes and Cartridges
Formulation	Up to 400 Litres tank
Isolator
Filling Line
Lyophiliser
Batch Size	30k units of 2R – up to 45k		3.6k units per hour
Formats	Vials from 2 to 100R		Vials from 2 to 100R PFS 1 to 10ml (option) Cartridges (option)
API Categories	Full containment - From Cat 1 to Cat 4+
Special Features	Low temperature - Inert atmosphere - Viscous products - Aseptic formulation - Minimised losses

Line 1

Line 2

Development and Analytical Capabilities

Process Research & Development Platform

2 Laboratories including: Isolator, Glovebox, Safety Cabinets
2 Lyophilisers, filling and capping machines for PR&D
Analytical platform including HPLC and uPLC
Storage chambers with different conditions for stress studies

Quality Control Platform

2 Laboratories including: Fumehoods and Safety Cabinets
HPLCs, uPLCs, LC-MS, Ion Chromatography
Microbiological platform to perform Bioburden, Sterility and endotoxins tests
Stability chambers for ICH stability studies

If you would like to keep up with the progress of the site construction and look for more information, please visit our Knowledge Centre.

Teaser Riom 2 - Episode 2: The work is continuing

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CARBOGEN AMCIS is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development. Our integrated services for Drug Substances (DS) and Drug Products (DP) provide innovative solutions to support timely and safe drug development.