これらの機能は主な基準に一致しますが、オプションのフィルターのすべてに一致するとは限りません。
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP), ISO
Use: Human
Region: APAC
Category / Product: BIOLOGICS
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium
Controlled Substances: Lowest potential for abuse
Region: Europe
Services: Manufacturing services, Development services
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Compliance: ISO
Batch Size: Small
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Markets: ANVISA (Brazil), CDSCO (India), EMA (EU)
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Batch Size: Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU)
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
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室温+2年で安定したqPCR製造
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組換え酵素とタンパク質に特化した GMP 準拠の生物製剤製造施設。
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組換えタンパク質とモノクローナル抗体 (mAb) に重点を置く開発製造受託機関 (CDMO)。
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当社は、貴社の医薬品を研究室規模から初期臨床段階、さらにはそれ以降の段階まで運ぶことができます。
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バイオ医薬品、ウイルスベクター、ワクチンの開発と製造の経験を持つ、信頼できる CDMO パートナーです。
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発酵工場
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私たちは株とバイオプロセスの開発、スケールアップ、バッチ生産に特化した研究開発部門として働いています。
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