Search and Find the CMO / CDMO You Need
Discover highly skilled partners for your drug development and manufacturing project.
Spain
BDI biotech Production Plant
BDI biotech
We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.
MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Regulatory services
REGION: Europe
COMPLIANCE: ISO
BSL (Biological Safety Level): 1
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: BIOLOGICS
Spain
53Biologics Production Plant
53Biologics
53Biologics is a Spanish CDMO specialized in decoding the production of biologicals, from DNA to proteins.
MARKETS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
BSL (Biological Safety Level): 1, 2
CATEGORY / PRODUCT: BIOLOGICS
COMPLIANCE: French Service-Public (CIR), EMA (EU GMP), FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority)
BATCH SIZE: Small, Medium, Large
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
BSL (Biological Safety Level): 3, 1, 2
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
REGION: Europe
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
BSL (Biological Safety Level): 3, 1, 2
MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), French Service-Public (CIR), EMA (EU GMP)
BATCH SIZE: Large, Small, Medium
USE: Human, Veterinary
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
REGION: North America
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Germany
Green Phoenix Labs GmbH
Green Phoenix Labs GmbH
Cell Therapy company with excess Cleanroom capacity.
MARKETS: EMA (EU)
SERVICES: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
USE: Human
BSL (Biological Safety Level): 1
THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CONTROLLED SUBSTANCES: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
BATCH SIZE: Small, Medium
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
COMPLIANCE: EMA (EU GMP)
CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
Limited view
BIOLOGICS manufacturing site
MAI network supplier
Contract Development and Manufacturing Organization (CDMO) with a focus on recombinant proteins and monoclonal antibodies (mAbs).
Location available after registration
Limited view
OLIGONUCLEOTIDES manufacturing site
MAI network supplier
Aseptic fill-finish and lyophilization for clinical-stage drug products.
Location available after registration
Limited view
OLIGONUCLEOTIDES manufacturing site
MAI network supplier
Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.
Location available after registration