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 SKAN
Filling Line BAUSCH+ STROEBEL
Lyophiliser HOF
Batch Size 30k units of 2R – up to 45k 3.6k units per hour
Formats Vials from 2 to 100ml Vials from 2 to 100ml
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.

To download the Riom 2 Fact Sheet, click on the link below or contact us today.