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Cultiply
Cultiply
Hiszpańskie CDMO, które opracowuje procesy produkcji i oczyszczania rekombinowanych białek, enzymów, DNA i innych produktów pochodzenia biologicznego.
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia)
Region: Europe
Compliance: ISO
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services
Controlled Substances: Lowest potential for abuse
Batch Size: Small, Medium
Category / Product: BIOLOGICS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
PARTICLE ENGINEERING manufacturing site
MAI network supplier
Rozwój i produkcja cGMP wysoce silnego API, w tym koniugatów przeciwciał i leków (ADC).
Lokalizacja dostępna po rejestracji
COSMETICS manufacturing site
MAI network supplier
Firma Creative Biostructure została założona ze szczególnym naciskiem na biologię strukturalną i badania nad białkami błonowymi.
Lokalizacja dostępna po rejestracji
BIOLOGICS manufacturing site
MAI network supplier
Mabion to europejski partner zajmujący się rozwojem i produkcją leków biologicznych, koncentrujący się na programach innowacyjnych dotyczących produktów biopodobnych, produkcji wielkocząsteczkowej.
Lokalizacja dostępna po rejestracji
Obiekty te spełniają Twoje główne kryteria, ale nie wszystkie opcjonalne filtry.
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.
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
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.
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
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
Licencjonowana witryna ATMP w Niemczech. Produkcja GMP i zwolnienie partii QP do terapii komórkowych i tkankowych.
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, SERVICES, BIOLOGICS
Region: Europe
JAFRAL
JAFRAL
Zintegrowany zakład biotechnologiczny zapewniający badania i rozwój, produkcję niezgodną z GMP i GMP, testy kontroli jakości oraz usługi napełniania i wykończenia zaawansowanych produktów…
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Compliance: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
BSL (Biological Safety Level): 1, 2
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Controlled Substances: Lowest potential for abuse
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism
Region: Europe
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Wieloproduktowe obiekty GMP dla substancji i produktów leczniczych.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), MHRA (UK)
BSL (Biological Safety Level): 1, 2
Use: Human
Batch Size: Large, Small, Medium
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Region: Europe
VIVEbiotech
VIVEbiotech
Twoje wiodące CDMO z certyfikatem GMP, przeznaczone wyłącznie do produkcji wektorów lentiwirusowych.
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
ProBio CDMO | Biologics Platform
Probio
Globalne GCT i leki biologiczne CDMO, przyspieszające proces przejścia od genu do rynku komercyjnego.
Region: APAC
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
Category / Product: BIOLOGICS
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Utwórz darmowe kontoAre you a pharmaceutical company seeking a reliable CMO or CDMO partner to accelerate your drug development process? Look no further than MAI CDMO Network. Our advanced search platform connects you with a vast network of qualified contract manufacturers and development organizations worldwide.
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- Create a Free Account: Sign up for a free account to access our extensive database of CMOs and CDMOs.
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