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Showing 40 facilities
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

CARBOGEN AMCIS | Aarau
Switzerland

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

Development and medium scale cGMP manufacturing including chromatography.

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, PARTICLE ENGINEERING

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

BATCH SIZE: Small, Medium

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Bubendorf
Switzerland

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC).

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human, Veterinary

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES, PARTICLE ENGINEERING

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

BATCH SIZE: Small, Medium

Green Phoenix Labs GmbH
Germany

Green Phoenix Labs GmbH

Green Phoenix Labs GmbH

Cell Therapy company with excess Cleanroom capacity.

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

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

MARKETS: EMA (EU)

SERVICES: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

USE: Human

BSL (Biological Safety Level): 1

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BIOLOGICS manufacturing site

MAI network supplier

GMP-compliant biologics manufacturing facility specializing in recombinant enzymes and proteins.

Location available after registration

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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

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BIOLOGICS manufacturing site

MAI network supplier

Mabion is a European biologics development and manufacturing partner focused on biosimilar, large molecule manufacturing, and innovation programs.

Location available after registration

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