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Why plasma protein therapies are safe

Safety is our industry’s highest priority. There are three types of safeguard measures used in plasma donation and manufacturing to ensure safe plasma protein therapies:

  1. Selection of starting material:
    donor screening/donor exclusion

  2. Testing for
    pathogens

  3. Elimination of
    pathogens

  • Cross donation
    management

  • Donor education

  • National donor deferral registry

  • Viral marker

Current manufacturing protocols are highly effective against pathogens.

The industry has a record of safety from pathogens for more than 20 years.

Evolving protocols

Unlike traditional pharmaceuticals or other biologics plasma protein therapies’ safety protocols are constantly evolving due to new and emerging pathogens.

Companies must continuously perform tests to demonstrate that their viral inactivation and removal steps work on new pathogens. Most recently, companies invested significant time and resources into researching the Zika virus to ensure it does not threaten the safety of plasma protein therapies.