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CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Desarrollo y fabricación cGMP de API de gran potencia, incluidos conjugados anticuerpo-fármaco (ADC)
MARKETS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
COMPLIANCE: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
CATEGORY / PRODUCT: SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
53Biologics Production Plant
53Biologics
53Biologics es una CDMO espa ola especializada en descifrar la producción de biológicos, desde el ADN hasta las proteínas, proporcionando desde la fase preclíni
MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium, Large
COMPLIANCE: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
CATEGORY / PRODUCT: SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Quality Assurance services
BSL (Biological Safety Level): 1, 2
THERAPEUTIC AREAS OF EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Bioconjugados (ADC) y fabricación clínica y comercial de anticuerpos
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Demo facility
Location available after registration
SERVICES manufacturing site
MAI network supplier
CDMO espa ola que desarrolla procesos de producción y purificación de proteínas recombinantes, enzimas, ADN y otros productos bioderivados.
Location available after registration
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