Category: Plasma Fractionation
Establishment of a local plasma fractionation to ensure a supply of plasma derivatives such as IVIG, RhIG, albumin, factor concentrates
Plasma Fractionation Considerations
This is an updated version of a previous post.
Procedure: Donor Collection Sites
Policy: COVID Convalescent Plasma Donor Qualification
Plasma Project Considerations for Middle East
This is an update of a previous post.
I have been involved with planning for several plasma fractionation projects in the Middle East.
Many clients expressed the interest in using local plasma to make plasma derivatives (e.g. factor concentrates, intravenous gamma globulin, albumin), feeling that local plasma was safer than using imported plasma. Some of these are in short supply in the world market so the only way to ensure their uninterrupted availability is to consider to manufacture them for local consumption.
Still, the major issue today is that it is difficult for any country in the region to collect enough plasma to make such a project feasible. When I first considered such planning, we were looking for as much as 250,000 raw liters of plasma annually. Since then, there are newer technologies that allow much smaller batches to be cost-effective. Alternatively, one could charge higher prices for using smaller batches from local plasma.
Still, it is likely that plasma must be imported to sustain a plant. There are different regulations for plasma donor qualification country-to-country. Many of these jurisdictions may do less screening and testing than is done for normal blood and apheresis donors. Other countries use their blood donors with the same requirement for both commercial plasma and blood donations.
In this era of emerging infectious diseases, I personally favor using the stringent blood donor criteria—same as routine collections. It is not what we know, but the unknown pathogens that are potentially the most dangerous.
In addition to building a fractionation plant, one must train staff for this highly technical operation. This may require developing a special curriculum to prepare students for these jobs.
To export the plasma to certain regions, one may have to use plasma quarantine. In this protocol, plasma is held or quarantined until the next donation is collected and passes screening. This requires a robust blood bank production software such as Medinfo to track serial donations.
There are other processes to consider: how to develop a transport network to keep plasma frozen at minus 80C viable in a region that reaches very high ambient temperatures.
I would recommend a graded approach to develop such an industry. First I would negotiate a plasma self-sufficiency arrangement. We would collect local plasma in the country and export it to a manufacturing plant in another country and the derivatives would be returned to us. This may require inspection by the accreditation agency of the processing country to allow importation of the raw plasma for manufacture.
Since it is unlikely any one country has enough plasma for manufacture, recruiting neighboring countries to participate in a manufacturing plant is important. Technology for such a plant is complex so establishing a joint venture with one of the plasma industry companies is essential. Some manufacturers are very keen to develop extra capacity since there is a world-wide shortage of plasma fractionation and are even willing to help obtain external plasma sources for such a plant.
Such a plant is an excellent way to develop local talent to run such a plant, including training of local staff to be the industrial engineers in the plasma fractionation process. It would take approximately two years of training to prepare engineers on-site at a plasma fractionation site if they have studied the necessary science and mathematics subjects.
Such a program would take several years of planning and development. Some of the major steps needed include:
- Acquiring software for a blood center with plasma brokering capabilities.
- Passing accreditations such as international AABB and CE for transfusion medicine to allow export of our plasma to the external manufacturing site in the initial plasma self-sufficiency phase
- Identifying extended sources of plasma to feed a manufacturing plant.
- Preparing a curriculum suitable for training as staff for the plant.
- Establishing a joint venture to share technology with a major plasma company to design, build, and operate a plasma fractionation plant.
Teaching Document: Irradiating RBCs from Outside Transfusion Medicine
This is a teaching document of a process to irradiate RBC components when our irradiators are not functioning. In our system, we used Mirasol pathogen-inactivation so our RBC units were affected. The number of units for advance irradiation was based on our historical usage of irradiated units across our system. The workweek is Sunday-Thursday so on Thursday special effort was made to have the minimum number of irradiated units available.
We used irradiated units for compatibility testing to avoid the possibility that the unit would be released without irradiation.
Emergency Interim Procedure:
- Verify the patient’s diagnosis/location: All Hematology-Oncology patients should receive irradiated blood. Refer to the list of diagnoses for which irradiation is indicated (attached).
- Only PRBCs need to be irradiated. Mirasol-treated (pathogen-inactivated) platelets can be used directly without irradiation in accordance to Council of Europe CE regulations.
- Attach radiation indicator labels to the selected units as per the irradiation procedure.
- Send the units for irradiation to the Radiation Oncology department.
- Verify that the proper dose of irradiation was received while in the Radiation-Oncology department.
- Keep a minimum stock of 20 group O-positive units irradiated at the start of each day AND before the start of the weekend on Thursday afternoon. Irradiate that number of group O-positive units plus any other specific requests for blood.
- You should use the irradiated units for crossmatching. DO NOT CROSSMATCH FIRST BEFORE IRRADIATING!! If the antibody screen is positive, refer the specimen to the Transfusion Service for further processing and selection of units.
- Note: If a special antigen typing is needed, we may have to irradiate after selecting the antigen-matched unit if it is not found in the group of irradiated units.
- If a unit is required for a child < 20 kg, it must be washed before release if the unit was irradiated more than 24 hours previously according to our irradiation policy.
Processes and Software Building 47: Apheresis Plasma
At HMC during my tenure, all plasma products—whole-blood and apheresis-derived were pathogen inactivated with riboflavin (Mirasol). In our software processes, I had options to release both Mirasol-treated and untreated (the latter in emergencies) and to aliquot either as needed. The same processes applied to COVID-19 convalescent plasma CCP except that they were performed in a quarantine production area. There were specific ISBT codes for CCP.