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53Biologics Production Plant
53Biologics
53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.
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
REGION: Europe
USE: Human, Veterinary
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Quality Assurance services
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Cultiply
Cultiply
Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.
MARKETS: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH SIZE: Small, Medium
CONTROLLED SUBSTANCES: Lowest potential for abuse
REGION: Europe
SERVICES: Manufacturing services, Development services
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
COMPLIANCE: ISO
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (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, PARTICLE ENGINEERING, 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 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Creative Biostructure was founded with a strong focus on structural biology and membrane protein research.
Location available after registration
BIOLOGICS manufacturing site
MAI network supplier
Mabion is a European biologics development and manufacturing partner focused on biosimilar, large molecule manufacturing, and innovation programs.
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
One-stop CDMO Solutions for APl and Key intermediates.
Location available after registration
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