供应美国Pfanstiehl注射级海藻糖

伴随着生物医药产业从小分子疗法向生物药的转变,关键性原料的管控变得更加复杂,标准也越来越高,除了产品本身的功能性品质,还对cGMP认证、优良的原料产地,以及无动物源成分做出了要求。全世界的科学家门正面临着无休止的培养基成分和赋形剂的筛选工作。科研人员经常发现由于原料的批间差异,会导致前期工作在资源与时间上被大量地浪费。

Pfanstiehl是Ferro集团的全资子公公司,成立于1919 年,具有近百年历史,生产符合cGMP 和ICH Q7A标准的注射级高纯度低内毒素(HPLE)的糖类(海藻糖、蔗糖、麦芽糖、甘露糖、甘露醇等等)、高活性的药用活性成分(原料药)、药用辅料和药物中间体,以及用作其他制药环节用途的各种高纯度糖类,所有的产品都在FDA备案,并且拥有SafeBridge认证,为全球生物医药行业提供了符合行业高标准要求的产品,并在全球单品销售10亿美金的生物炸弹药中,其中7个药品使用Pfanstiehl的糖类作为其辅料,其中5个使用海藻糖,显著区别于目前市场上其他生产厂家在食品GMP条件下生产的符合药典的海藻糖,是市场上可以接受现场审计生产注射级海藻糖的生产企业。2013年Pfanstiehl开始独立运营,为注射型蛋白药、疫苗生产等企业提供更加专业、便捷的优质服务。

此外,Pfanstiehl因应全球客户的需求,开发并在最近发布上市了高纯度、低内毒素、无动物源成分的半乳糖,其原理是通过在细胞培养基中添加半乳糖以达到减少乳酸和氨堆积,从而提高整个细胞培养的表现以及蛋白产量,在治疗性蛋白和生物仿制药领域,收获越来越多的赞誉。

2014年上海金畔生物科技有限公司以与美国Pfanstiehl确定代理关系,并启动注射级海藻糖和蔗糖在药监局的备案工作,国内采购不到药监局备案的注射级海藻糖辅料的时代即将结束。上海金畔生物科技有限公司在国内备有大量Pfanstiehl注射级海藻糖现货。除了美国Pfanstiehl外,上海金畔生物科技有限公司还代理Kerry各种蛋白胨、酵母粉(如HyPep1510、HyPep1512、HyPep4601N、HpPep5603、HySoy、Amicase、Hy Case SF、NZ Amine 等),AppliChem药典级试剂,Cygnus宿主蛋白残留检测试剂盒等,欢迎致电021-50837765了解更多产品信息。

Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond. Pfansteihl Brand, High Purity Low Endotoxin (HPLE) Trehalose is used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates throughout the formulation and freeze/thaw life cycle of therapeutics. It is also widely applied as a key component in cryopreservation/freeze media to stabilize cell membranes and improve the recovery and robustness of cells used for bioproduction and cell therapy.

The stabilizing benefits of trehalose include but are not limited to:
•      Monoclonal Antibodies (mAbs)
•      Fusion Proteins
•      Antibody Fragments (fAbs)
•      Peptides
•      Stem cells
•      Vaccines

Pfanstiehl Brand Trehalose is available as USP-NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia) and JP (Japanese Pharmacopoeia). Pfanstiehl also holds a US DMF for the Trehalose (T-104-4) product.

附注:

a. ICH(人用药物注册技术要求国际协调会议,International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)Q7a就代表药物活性成分(通常指原料药)的GMP标准。

b.美国药典(USP)收录的是原料药、成品药及补充剂的质量标准;而美国处方集(NF) 是国家处方集的简称,收录的是制剂中的附加剂即辅料的质量标准。

Trehalose is a non-reducing disaccharide consisting of two glucose molecules linked by an α, α–1,1 bond. Pfansteihl Brand, High Purity Low Endotoxin (HPLE) Trehalose is used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates throughout the formulation and freeze/thaw life cycle of therapeutics. It is also widely applied as a key component in cryopreservation/freeze media to stabilize cell membranes and improve the recovery and robustness of cells used for bioproduction and cell therapy.

The stabilizing benefits of trehalose include but are not limited to:
•      Monoclonal Antibodies (mAbs)
•      Fusion Proteins
•      Antibody Fragments (fAbs)
•      Peptides
•      Stem cells
•      Vaccines

Pfanstiehl Brand Trehalose is available as USP-NF (United States Pharmacopoeia—National Formulary), EP (European Pharmacopoeia) and JP (Japanese Pharmacopoeia). Pfanstiehl also holds a US DMF for the Trehalose (T-104-4) product.