显示中 24 设施
建议结果
这些设施符合您的主要标准，但不符合所有可选过滤器。
荷兰
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
用于原料药和药品的多产品 GMP 设施。
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU), MHRA (UK)
德国
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
德国获得许可的 ATMP 站点。细胞和组织疗法的 GMP 制造和 QP 批次放行。
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (S) Sensory organs, (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
Compliance: EMA (EU GMP)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Region: Europe
Use: Human
Services: Analytical / QC services, 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, 2
Markets: EMA (EU)
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
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP), ISO
Use: Human
Region: APAC
Category / Product: BIOLOGICS
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
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
视野有限
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
我们可以将您的药物从实验室规模转移到早期临床阶段及以后。
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视野有限
BIOLOGICS manufacturing site
MAI network supplier
您值得信赖的 CDMO 合作伙伴，在生物制药、病毒载体和疫苗的开发和制造方面拥有丰富的经验。
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视野有限
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
mRNA 和 LNP 制造以及填充和完成。
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视野有限
BIOLOGICS manufacturing site
MAI network supplier
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视野有限
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
早期无菌灌装完成
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视野有限
BIOLOGICS manufacturing site
MAI network supplier
非无菌临床设施（口服固体剂量）
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视野有限
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
口服固体制剂（OSD）、鼻用、吸入、无菌干粉剂和液体药品的开发和制造。
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