Showing 55 facilities
Spain
mAbxience Garín
mAbxience CDMO
24,000 L single-use capacity for antibody-like molecule GMP manufacturing
Batch Size: Large, Medium
Compliance: ISO, TITCK (Turkish Health Authorities), ANVISA (Brazil B-GMP), COFEPRIS, ICH, MHRA (UK GMP), ANMAT (Argentina nueva GMP), ISP (Chile BPM), World Health Organization (GMP / HACCP), EMA (EU GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), ANVISA (Brazil), MHRA (UK)
Markets: ANMAT (Argentina), Rest of World, COFEPRIS (Mexico), Russian Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Turkish Health Authorities, EMA (EU), INVIMA (Colombia), SFDA (Saudi Arabia)
Use: Human
Services: Analytical / QC services, Manufacturing services
Therapeutic Areas of Expertise (ATC): (B) Blood and blood forming organs, (D) Dermatologicals, (N) Nervous system, (J) Antiinfectives for systemic use, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Region: Europe
Category / Product: BIOLOGICS
Spain
mAbxience Genhelix
mAbxience CDMO
24,000 L single-use capacity for antibody-like molecule development and GMP manufacturing, from cell line development to commercial drug substance
Batch Size: Large, Small, Medium
Compliance: ISO, TITCK (Turkish Health Authorities), ANVISA (Brazil B-GMP), COFEPRIS, ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), TGA (Australia GMP), Roszdravnadzor (Russia GMP), ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), PMDA (Japan), ANVISA (Brazil), Health Canada, MHRA (UK), TGA (Australia)
Markets: FDA (USA), PMDA (Japan), Health Canada (Canada), ANMAT (Argentina), Rest of World, COFEPRIS (Mexico), Russian Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Turkish Health Authorities, EMA (EU), MHRA (UK), MFDS (South Korea), INVIMA (Colombia), MSPAS (Guatemala), SFDA (Saudi Arabia), TGA (Australia)
Use: Human, Veterinary
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services
Therapeutic Areas of Expertise (ATC): (B) Blood and blood forming organs, (D) Dermatologicals, (N) Nervous system, (J) Antiinfectives for systemic use, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Region: Europe
Category / Product: BIOLOGICS
Compliance: ANMAT (Argentina nueva GMP)
Markets: ANMAT (Argentina), Rest of World
Services: Development services, Manufacturing services
Region: Europe
Category / Product: BIOLOGICS
Netherlands
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Multi-product GMP facilities for Drug Substance and Drug Product.
Markets: EMA (EU), MHRA (UK)
Batch Size: Large, Small, Medium
BSL (Biological Safety Level): 1, 2
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, ANALYTICAL CRO, BIOLOGICS
Region: Europe
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)
Use: Human
BSL (Biological Safety Level): 1, 2
Compliance: ISO, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), EMA (EU GMP)
Batch Size: Small
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (A) Digestive tract and metabolism
Region: Europe
Switzerland
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Development and medium scale cGMP manufacturing including chromatography.
Use: Human, Veterinary
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), CDSCO (India), MFDS (South Korea), TGA (Australia)
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services
Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)
Batch Size: Small, Medium
Category / Product: ANALYTICAL CRO, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Region: Europe
Switzerland
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC).
Services: Development services, Analytical / QC services, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (V09-10) Radiopharmaceuticals, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism
Batch Size: Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: PARTICLE ENGINEERING, ANALYTICAL CRO, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Spain
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BSL (Biological Safety Level): 1, 2
Use: Human
Batch Size: Large, Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Region: Europe
Category / Product: BIOLOGICS
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU)
Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BSL (Biological Safety Level): 1, 2
Use: Human
Batch Size: Large, Medium
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe
Germany
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
Licensed ATMP site in Germany. GMP manufacturing and QP batch release for cell and tissue therapies.
Services: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU)
BSL (Biological Safety Level): 1, 2
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Batch Size: Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, ANALYTICAL CRO, BIOLOGICS
Region: Europe
Spain
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
End-to-end internal capabilities from cell line development to commercial manufacturing.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BSL (Biological Safety Level): 1, 2
Use: Human, Veterinary
Batch Size: Large, Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe
Spain
VIVEbiotech
VIVEbiotech
Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.
Markets: EMA (EU), FDA (USA), MHRA (UK)
Region: Europe
Compliance: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Category / Product: BIOLOGICS
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