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Spain
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
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
One-stop CDMO Solutions for APl and Key intermediates.
Location available after registration
Limited view
BIOLOGICS manufacturing site
MAI network supplier
Process Development, Gene to Cell Line to GMP to Formulation Development, Analytical Development and Fill-Finish.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Integrated development and cGMP manufacturing site.
Location available after registration
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Belgium
White Raven - Legiapark
White Raven
Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.
BATCH SIZE: Small, Medium
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS
COMPLIANCE: EMA (EU GMP)
REGION: Europe
USE: Human
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
SERVICES: Manufacturing services, Packaging
BSL (Biological Safety Level): 1, 2
MARKETS: EMA (EU)
Limited view
BIOLOGICS manufacturing site
MAI network supplier
Kemwell Biopharma is a biologics focused CDMO company providing services to global biopharmaceutical organisations.
Location available after registration
Limited view
SERVICES manufacturing site
MAI network supplier
GMP-compliant biologics manufacturing facility specializing in recombinant enzymes and proteins.
Location available after registration
Limited view
BIOLOGICS manufacturing site
MAI network supplier
Mabion is a fully integrated CDMO offering services associated with the development and GMP manufacturing of biotherapeutics.
Location available after registration
United Kingdom
Upperton Pharma Solutions
Upperton Pharma Solutions
Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.
BATCH SIZE: Small, Medium
THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (C) Cardiovascular system, (N) Nervous system
CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDES, BIOLOGICS
CONTROLLED SUBSTANCES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
USE: Human
COMPLIANCE: MHRA (UK GMP)
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
MARKETS: FDA (USA), EMA (EU), TGA (Australia), Health Canada (Canada), MHRA (UK)
BSL (Biological Safety Level): 1
Spain
VIVEbiotech
VIVEbiotech
Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.
BATCH SIZE: Small, Medium, Large
COMPLIANCE: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), FDA (cGMP)
REGION: Europe
USE: Human
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARKETS: FDA (USA), EMA (EU), MHRA (UK)
CATEGORY / PRODUCT: BIOLOGICS
BSL (Biological Safety Level): 1, 2