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Aseptic Production

CARBOGEN AMCIS SAS located in Riom, France, supplies aseptic clinical trial batches of APIs, such as highly potents, cytotoxics, proteins, mAbs, peptides, enzyme inhibitors, antibiotics (non-ß-lactam) and vaccine (non-live). The facility allows sterile and GMP-compliant handling of injectables in liquid or freeze-dried form of all occupational exposure bands, such as cytostatics and cytotoxics. New generation isolators allow to reahc a sterility of Grade A (ISO 4.8) in the production area throughout the entire process. Containment is ensured through rigid barrier isolation, flexible segregation of key equipment, and air filtration into and out of the building by means of an HVAC system. The GMP plant was successfully inspected by the French Health Agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé – ANSM) over the past 10 years. CARBOGEN AMCIS SAS offers aseptic filling in a wide range of fill volumes in vials, syringes and cartridges. Since 2000, the Riom site has manufactured over 400 GMP batches, 220 clinical batches and 100 media fill tests covering a wide range of processes. Thanks to a strong expertise in sterile manufacturing and specific skills, CARBOGEN AMCIS SAS is able to minimize product loss throughout the manufacturing steps and deliver the maximum units to your clinical needs.

Our offerings include the GMP parenteral production of:

  • Pre-clinical batches (for technical, stability or toxicology studies)
  • Clinical batches (for phases I, II and III)
  • Validation of aseptic processes (media fill testing)
  • Liquid forms, semi-solids and injectables
  • Maximum batch size: 5000 x 2 mL vials
  • Highly-potent drugs, cytotoxics
  • Proteins, mAbs, peptides, enzyme inhibitors and antibiotics (non--lactam) and vaccines (non-live)
  • Compounds sensitive to heat and oxidation (such as e.g. peptides, proteins and ADCs)

Highlights of key facilities and instrumentation:

  • Isolators operating in unidirectional air flow and at regulated temperature
  • Interconnection with other equipment through rapid transfer port system (RTP alpha/beta ports)
  • Bag-In/Bag-Out system for the safe exchange of High-Efficiency Particulate Air (HEPA) filters
  • Special manufacturing conditions: inactinic light, Nitrogen atmosphere, flushing and backfilling
  • Terruzzi freeze dryer (1.2 square meters) with CIP and SIP for GMP production
  • VHP (Vaporized Hydrogen Peroxide) disinfection system to decontaminate and sterilize air and surfaces
  • Autoclave for sterilization
  • Grade A (ISO 4.8) Sterility
  • Dry heat oven
  • HVAC system with 24/7 monitoring
  • Monitored storage facilities
  • 24/7 monitoring system during freeze drying processes
  • Backup power system with double-layer safety (generator + uninterruptible cells) to ensure continuous manufacturing operation
  • In-house storage (-80°C, -20°C and 2-8°C) with 24/7 monitoring

Integrated services include microbiological and analytical controls (EP & USP NF), 100 percent visual inspection and container closure integrity testing, stability studies (ICH guidelines) and batch release.

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News
21 July 2017
CARBOGEN AMCIS Sites at Bubendorf, Aarau and Neuland in Switzerland Successfully Pass Swissmedic Inspection

11 August 2016
Dishman Celebrates a Decade of Success Since Acquisition of CARBOGEN AMCIS

14 July 2016
CARBOGEN AMCIS Sites at Aarau and Neuland in Switzerland Successfully Pass FDA Inspection


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