$850.00

Product Description

Exbumin® is a recombinant human serum albumin that is manufactured using good manufacturing practices at an ISO9001:2015 certified facility in Kansas, USA. It is blood-free and has been used in more than 250,000 injections. It is one of the few excipients available to improve viral stability for vaccines and gene therapies. Exbumin is also used to maintain tissue viability during cryo-preservation or storage. And, Exbumin helps to stabilize cells and tissue used in cell therapy and regenerative medicine applications. Exbumin has been approved for use as an excipient in injectible therapeutics by regulatory agencies.

Advantages

• Includes sodium specification to control sodium content for final formulation
• Regulatory support available
• Manufactured in the United States, in a tertiary-level, animal component-free, ISO 9001 certified facility
  • Raw materials, manufacturing equipment, and packaging is certified blood free and animal free
  • Manufacturing equipment has never been exposed to animal derived components
  • Manufacturing host is blood free and animal free

InVitria诸如牛胎血清（FBS），牛和人血清白蛋白以及牛和人转铁蛋白等动物成分已在许多生物过程中成为流行成分，但由于担心，科学家于1990年代开始寻找去除血清和其他动物产品的方法有关产品质量，安全性和动物管理的信息。动物产品是不受欢迎的，因为它们具有传播诸如agents病毒（疯牛病）和病毒（HIV）之类的传染因子的风险。此外，动物成分和血液来源的产品不确定，导致批次间差异很大。由于这些原因，美国食品药品管理局（FDA），欧洲药品管理局（EMA）和其他监管机构不鼓励使用这些动物成分。迄今为止，InVitria已开发并商业化了八种重组蛋白和细胞培养基补充剂。InVitria的产品开发团队有一个积极的计划，可以根据客户需求扩展该产品线。