CONSULTATION SERVICE
Consultation Service Implementation of appropriate measures to ensure pathogen safe therapeutic proteins derived from human plasma or cell cultures is comprehensively accompanied.
Three complementary approaches govern the pathogen safety:
- Selection and testing of starting and raw material from human or animal origin for the absence of viruses infectious and/or pathogenic for humans and for the absence of prions, the causative agent for TSEs (Transmissible Spongiform Encephalopathies)
- Testing product intermediates – cryo-depleted plasma pool for fractionation for the production of plasma-derived medicinal products and unprocessed bulk of fermenter harvests for the production of cell culture derived proteins (e.g. monoclonal antibodies, coagulation factors, enzymes) for the absence of viruses infectious and/or pathogenic for humans
- Inactivation and removal of viruses and prions by the manufacturing process of therapeutic proteins has to be demonstrated by virus validation and prion evaluation studies (performed according regulatory guidance and scientific principles)
- Sterility of therapeutic proteins has to be demonstrated
Implementation of appropriate measures to ensure pathogen safe medical devices derived from material of human or animal origin is comprehensively accompanied.
At least two complementary approaches govern the pathogen safety:
- Selection and testing of starting and raw material from human or animal origin for the absence of viruses infectious and/or pathogenic for humans and for the absence of prions, the causative agent for TSEs (Transmissible Spongiform Encephalopathies)
- Inactivation and removal of viruses and prions by the manufacturing process of medical devices has to be demonstrated by virus validation and prion evaluation studies (performed according regulatory guidance and scientific principles)
- Sterility of therapeutic proteins has to be demonstrated
Implementation of appropriate measures to ensure safety of vaccines regarding adventitious agents is comprehensively accompanied.
At least two complementary approaches govern the pathogen safety:
- Selection and testing of starting and raw material from human or animal origin for the absence of viruses infectious and/or pathogenic for humans including testing of virus stocks for adventitious agents and for the absence of prions, the causative agent for TSEs (Transmissible Spongiform Encephalopathies)
- Sufficient inactivation capacity of the production process of inactivated virus vaccines and freedom of adventitious viruses in live attenuated virus vaccines has to be demonstrated
- Sterility of vaccines (applied parenterally) has to be demonstrated
RISK ASSESSMENT
Assessment of the risk of finished products to transmit pathogens is comprehensively accompanied. This risk assessment is based on the potential amount of viruses or other pathogens in the starting material of the product and the process intermediate, respectively, the capacity of the manufacturing process to inactivate and/or remove such pathogens and the volume of the starting material or process intermediate required to produce one vial or dose of product.