CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS | Saint-Beauzire

Custom formulation development and GMP sterile manufacture of liquid and lyophilized drug product

About the plant

Custom formulation development and GMP sterile manuacture of liquid and lyophilized drug product

Carbogen Amcis´ purpose built GMP certified Annex 1 compliant state-of-the-art facility, opened in Q1 2023. Carbogen Amcis is dedicated to the development, sterile production, QC testing and release of injectable drug products. The facility has two fully automated filling lines and allows CARBOGEN AMCIS to collaborate with clients providing flexible access to phase appropriate scale of clinical trial material, through phase I to phase III and commercial. The facility has the capability to handle complex formulations, including a large range of APIs from biologics to highly potent compounds.

Activities

• Two production lines offering liquid and lyophilized sterile injectable drug product
• Aseptic formulation
• Handling of Highly Potent products with OEB 4+ category in both liquid and lyophilized formats.
• Drug product formulation development and analytical method development, transfer and validation
• State of the art QC laboratories to support in-process and finished product testing.
• Microbiological platform to perform bioburden, sterility and endotoxin testing
• Stability chambers to support ICH stability studies

 

 

 

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• French Service-Public (CIR)
• World Health Organization (GMP / HACCP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• ANMAT (Argentina nueva GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)
• UAE Ministry of Health & Prevention
• SFDA (Saudi Food & Drug Authority)

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Activity

• FDF / DRUG PRODUCTS manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs
• Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

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