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HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
Spain

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

HISTOCELL

Histocell is a Spanish CDMO that develops and manufactures cell therapies, secretomes and exosomes, as well medical devices.

SERVICES: Development services, Analytical / QC 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), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia)

COMPLIANCE: ISO, EMA (EU GMP)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

REGION: Europe

Nexora Cell and Tissue Therapy Manufacturing Site
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 > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

COMPLIANCE: EMA (EU GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

REGION: Europe

MARKETS: EMA (EU), ANVISA (Brazil), CDSCO (India)

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human

BSL (Biological Safety Level): 1, 2

THERAPEUTIC AREAS OF EXPERTISE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

BATCH SIZE: Small

CATEGORY / PRODUCT: BIOLOGICS, FDF / DRUG PRODUCTS

Cellex Cell Professionals
Germany

Cellex Cell Professionals

Cellex Cell Professionals

CGT CDMO Cell Manufacturing Plant and Collection Center for Starting Materials

MARKETS: EMA (EU), FDA (USA)

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

COMPLIANCE: FDA (cGMP), EMA (EU GMP)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS

Limited view

COSMETICS manufacturing site

MAI network supplier

Creative Biostructure was founded with a strong focus on structural biology and membrane protein research.

Location available after registration

Limited view

BIOLOGICS manufacturing site

MAI network supplier

Your trusted CDMO partner with experience in the development and manufacturing of biopharmaceuticals, viral vectors, and vaccines.

Location available after registration

Limited view

COSMETICS manufacturing site

MAI network supplier

Contract Development & Manufacturing Organisation

Location available after registration

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