CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS | Bubendorf

Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC)

About the plant

Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC)

Our facility located in Bubendorf – a municipality in the district of Liestal in the canton of Basel-Country in Switzerland – is the current headquarters of CARBOGEN AMCIS.

The larger scale production facility was opened in 1987, and in more than 25-year of history it has continuously adapted to the changing needs of the pharmaceutical industry.

Activities

• Process optimization and supply of late-phase and commercial APIs
• Highly potent manufacturing up to 100 kg scale, up to Category 4
• Bioconjugation manufacturing
• Chromatography capabilities (including highly potent compounds)

---

Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• ANVISA (Brazil B-GMP)
• PMDA/MHLW (Japan GMP)

---

Activity

• ADC & NDC (Antibody-drug), CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients) manufacturing

---

Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
• 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)
• DEA: N/A
• BSL:
• Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals
• 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), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Turkish Health Authorities

---

Batch Size / Reactor

• Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L

---

Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, DMF (Drug Master File) preparation and submission, Milling, Safety studies, Nitrosamine risk assessment, Impurity synthesis

---