Purity
In vivo adventitious virus testing: as recommended by FDA, ICH Q5A; 1993, 1997, PTC; 9CFR 113.46, 113.47 and 113.53

In vitro adventitious virus testing: as recommended by FDA, ICH Q5A; 1993, 1997, PTC; 9CFR 113.46, 113.47 and 113.53

• In-vivo test for adventitious virus as recommended in FDA, PTC
• Test for retrovirus by fluorescent product enhanced reverse transcriptase
• Test for bovine virus according to 9 CFR 113.53
• Test for porcine virus according to 9 CFR 113
• Test for indication of specific virus by QPCR or Endpoint PCR
• Testing serum alone for bovine diarrhea virus (BVDV1) and bovine rotavirus (BRV)
• Testing trypsin alone for Porcine Parvovirus (PPV)
• Testing product for both porcine and bovine viruses
• Endotoxin (LAL)

Other Potential adventitious agents

• Mycoplasma PCR, DNA staining and direct culture
• Retroviral Reverse Transcriptase by fluorescent product enhanced reverse transcriptase

Sterility

• Bacteriostasis/Fungistasis
• Sterility (Bacterial and Fungal)