Product/Service

Exbumin® – Recombinant Human Albumin Excipient

Source: InVitria
Exbumin

Exbumin rHSA has passed regulatory approval in the US and Europe as a final-formulation excipient for therapeutic applications. 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. It also helps to stabilize cells and tissue used in cell therapy and regenerative medicine applications.

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 hundreds of thousands of 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 injectable therapeutics by regulatory agencies.

Advantages

  • Regulatory support available
  • Manufactured in the United States, in a tertiary-level, animal component-free, ISO 9001:2015 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
  • Includes sodium specification to control sodium content for final formulation