Plasma Collection

Plasma collection is highly regulated in China. Plasma is collected from human donors at stringently controlled and government-licensed facilities. These facilities use advanced biotechnology to process the plasma.

Government Regulations

The plasma industry in China is highly regulated. In March 2006, the Ministry of Health promulgated certain “Measures on Reforming Plasma Collection Stations,” whereby the ownership and management of PRC plasma stations are required to be transferred to plasma-based biopharmaceutical companies and the local government is charged with regulatory supervision and administrative control in accordance with the policies of the central government. These measures also tightened operational standards for plasma stations. As a result, all plasma stations now have direct supply relationships with their parent fractionation facilities. In 2011, on the 11th National People’s Congress which contemplated the China’s 12th Five-Year Plan, Mr. Zhu Chen, China’s Minister of Health at the time, encouraged China’s plasma industry to double plasma supply from 2011 to 2015 to meet China’s needs. As a result, more plasma stations are expected to be built throughout China in the foreseeable future.

Donor Safety

Numerous safety measures are in place to help assure a donor’s health and safety. First, new donors must pass a medical screening, blood test and health questionnaire to be eligible to donate.

All donors are retested for eligibility prior to each donation. Testing includes blood pressure, weight, temperature, total protein and hematocrit, HBsAb, ALT, plasma protein, HCV and HIV antibodies, RPR test for syphilis, and screening for erythrolysis, lipemia, macroscopic red blood cells and any other irregularities.

Plasma Donation Process

1. Check-in at reception

Each plasma collection facility is only allowed to collect plasma from healthy donors within its respective districts (“Residence Requirement”). All donors must present their national identification card as a proof of identity and compliance with the Residence  Requirement. Additionally, each donor’s confirmed through fingerprint identification.

  • Facial identification
  • Five-point fingerprint identification
  • Five-point fingerprint identification
2. Health screening and physical exam

All potential donors receive a physical exam, blood test and full medical history to verify their eligibility to donate.

3. Plasmapheresis Procedure

Once a donor is approved, he or she is escorted to a comfortable, plasma donation bed. Trained medical staff person will complete the venipuncture, or insert a needle in the donor’s arm to draw blood, and connect the donor with the plasmapheresis device, a specialized device used to collect plasma. The automated plasmapheresis device removes whole blood, separates plasma from the other blood components and then returns those components to the donor. During the procedure, a sterile, one-time collection kit is used and the donor’s blood never leaves the device.

4. Donor rest and receiving compensation

Each plasma collection facility is only allowed to collect plasma from healthy donors within its respective districts (“Residence Requirement”). All donors must present their national identification card as a proof of identity and compliance with the Residence Requirement. Additionally, each donor’s confirmed through fingerprint identification.

  • Plasma Donor Managgement
5. Plasma Storage and Virus Testing

Collected plasma is packaged in 25 separate 600g bags and stored at 20°C shortly after collection to ensure that it will congeal  within 6 hours. Each bag is labeled with a computer-generated tracking code and has a separate “pig tail” with a small plasma  sample for additional virus testing purposes at the manufacturing plant.

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