Next Generation Hemoglobin Based Oxygen Carrier, Oxyvita C, with Coagulation Capacity using a Modified Lyophilization Process: Protection of Components

OxyVita, Inc. has developed proprietary technology to lyophilize a next generation Hemoglobin-Based-Oxygen-Carrier (HBOC) and coagulation components (plasma and platelets) without altering the specific properties of these components. The average molecular weight (17MDa) and hydrodynamic radius (36nm) of the OxyVita C polymers are similar to the solution form from which the powder is produced, indicating no protein dissociation or unfolding during lyophilization. The reconstitution of OxyVita C powder is ∼15 sec. in water. The liquid form of this HBOC is currently in pre-clinical studies as a dedicated oxygen delivery protein. The proprietary process which affords specific molecular protection to OxyVita C has now been applied to protect lyophilized human coagulation components (plasma and/or platelets). Natural platelets have a shelf life limited of 5 days. By implementing this protection technology, it is possible to extend the storage of freeze-dried platelets for at least 30 days, maintaining functionality as evident from repeated coagulation studies using a PAP-8 analyzer (Bio-Data).These studies exhibited the same coagulation capacity as fresh plasma or platelets (∼78%) using a PAP-8 analyzer. After 30 days of powder storage, a decrease of only 7% activity was observed. Solubility of the powder platelets was ∼10 sec. Reconstitution in different (IV) fluids has been shown in vitro with these preparations. Consistent results with 6 batches of powder plasma and 12 batches of powder platelets produced to date have been observed. Availability of each product provides flexibility for an appropriate treatment mode for a clinical situation, allowing: 1) only use the oxygen delivery component (OxtVita C) in the powder form; 2) a combination of OxyVit C with coagulation capacity (multifunctional resuscitation fluid); or 3) only coagulation enhancement using either dried plasma or platelets.