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HIPRA BIOTECH SERVICES | Amer
西班牙

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

从细胞系开发到商业制造的端到端内部能力。

市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

批量大小: 小的, 中等的, 大的

类别/产品: FDF / 药品, 生物制剂

遵守: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS

地区: 欧洲

使用: 人类, 兽医

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务

OEB(职业暴露带): 2(PDE = 1,000 - 10,000 微克/天), 1 / 低危害(PDE > 10,000 µg/天), 3(PDE = 100 - 1,000 微克/天)

BSL(生物安全等级): 1, 2

53Biologics Production Plant
西班牙

53Biologics Production Plant

53Biologics

53Biologics 是一家西班牙 CDMO,专门从事从 DNA 到蛋白质等生物制品生产的解码。

市场: 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)

批量大小: 小的, 中等的, 大的

遵守: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO

地区: 欧洲

使用: 人类, 兽医

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 质量保证服务

类别/产品: 生物制剂

BSL(生物安全等级): 1, 2

BDI biotech Production Plant
西班牙

BDI biotech Production Plant

BDI biotech

我们是一个专门从事菌株和生物工艺开发、放大和批量生产的研发部门。

市场: 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)

批量大小: 小的, 中等的

地区: 欧洲

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务

类别/产品: 生物制剂

BSL(生物安全等级): 1

遵守: ISO

Cultiply
西班牙

Cultiply

Cultiply

西班牙 CDMO,开发重组蛋白、酶、DNA 和其他生物衍生产品的生产和纯化工艺。

市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), 俄罗斯卫生当局, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

批量大小: 小的, 中等的

受控物质: 滥用可能性最低

地区: 欧洲

服务: 制造服务, 开发服务

类别/产品: 生物制剂

BSL(生物安全等级): 1, 2

OEB(职业暴露带): 1 / 低危害(PDE > 10,000 µg/天)

遵守: ISO

Rodon Biologics
葡萄牙

Rodon Biologics

Rodon Biologics - RDN Serviços de Biotecnologia

Rodon Biologics 在为第三方开发生物制药产品方面提供卓越服务。

批量大小: 小的

类别/产品: 服务, 生物制剂, 营养保健品

地区: 欧洲

服务: 分析/质量控制服务, 开发服务

BSL(生物安全等级): 1, 2

HIPRA BIOTECH SERVICES | Aiguaviva
西班牙

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

从细胞系开发到商业制造的端到端内部能力。

市场: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

批量大小: 小的, 中等的, 大的

遵守: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS

地区: 欧洲

使用: 人类

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务

OEB(职业暴露带): 2(PDE = 1,000 - 10,000 微克/天), 1 / 低危害(PDE > 10,000 µg/天), 3(PDE = 100 - 1,000 微克/天)

类别/产品: 生物制剂

BSL(生物安全等级): 1, 2

批量大小: 中等的, 大的

专业治疗领域 (ATC): (R) 呼吸系统, (G) Genito泌尿系统和性激素, (J) 全身使用的抗感染药

类别/产品: FDF / 药品, 生物制剂

遵守: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO

地区: 欧洲

使用: 人类

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务

BSL(生物安全等级): 1, 2

市场: EMA (EU)

批量大小: 小的

专业治疗领域 (ATC): (R) 呼吸系统, (G) Genito泌尿系统和性激素, (A) 消化道和新陈代谢

类别/产品: FDF / 药品, 生物制剂

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

地区: 欧洲

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

使用: 人类

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 开发服务, 包装, 质量保证服务

BSL(生物安全等级): 1, 2

CZ Vaccines | Large Scale Plant Spain
西班牙

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

一次性商业规模设施

批量大小: 中等的, 大的

专业治疗领域 (ATC): (R) 呼吸系统, (M) 肌肉骨骼系统, (G) Genito泌尿系统和性激素, (J) 全身使用的抗感染药, (N) 神经系统

类别/产品: FDF / 药品, 生物制剂

遵守: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO

地区: 欧洲

使用: 人类

服务: 分析/质量控制服务, 后勤, 制造服务, 监管服务, 包装, 质量保证服务

BSL(生物安全等级): 1, 2

市场: EMA (EU)

视野有限

服务 manufacturing site

MAI network supplier

符合 GMP 要求的生物制剂生产设施,专门生产重组酶和蛋白质。

注册后可用位置

视野有限

FDF / 药品 manufacturing site

MAI network supplier

合同开发和制造组织 (CDMO),专注于重组蛋白和单克隆抗体 (mAb)。

注册后可用位置

视野有限

FDF / 药品 manufacturing site

MAI network supplier

Creative Biostruct 成立时重点关注结构生物学和膜蛋白研究。

注册后可用位置

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