
CZ Vaccines
Instalación de Ensayos Clínicos
Batch Size: Small
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS, CHEMICAL-SYNTHETIC
Compliance: EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Markets: ANVISA (Brazil), CDSCO (India), EMA (EU)
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 2

VIVEbiotech
Su CDMO líder con certificación GMP dedicada exclusivamente a la producción de vectores lentivirales.
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP)
Category / Product: SERVICES, OLIGONUCLEOTIDES, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU), TGA (Australia)
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents

Green Phoenix Labs GmbH
Cell Therapy company with excess Cleanroom capacity
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
Compliance: EMA (EU GMP)
Controlled Substances: Lowest potential for abuse, Low potential for abuse
Region: Europe
Use: Human
Services: Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1
Markets: EMA (EU)

Cellex Cell Professionals
Planta de fabricación de terapias celulares (CGT CDMO) y centro de recogida de materiales de partida
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC
Compliance: EMA (EU GMP), FDA (cGMP)
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU)
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (B) Blood and blood forming organs
MAI network supplier
CDMO global de servicios integrales en biológicos
Location available after registration
MAI network supplier
Demo facility
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MAI network supplier
Soluciones integrales de CDMO para API e intermedios clave.
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