9CFR Testing Services

Accredited to ISO 17025 by the American Association for Laboratory Accreditation (Certificate 2880.01):

Testing on ingredients of animal origin that are used in the production of biologics for adventitious agents per Title 9 of the Code of Federal Regulations, 113.53 (c), 113.46, and 113.47.

• Bovine 9CFR Testing
  • Serum
• Modified Bovine 9CFR Testing – 9CFR guidelines are followed with modifications to fit the product
  • Bovine serum albumin
  • Raw materials
  • Non-serum samples
• Equine 9CFR Testing
  • Serum 
• Porcine 9CFR Testing
  • Serum
• Modified Porcine 9CFR Testing – 9CFR guidelines are followed with modifications to fit the product
  • Raw materials
  • Non-serum samples
• Porcine Parvovirus Testing on Trypsin (113.53 (d), 113.47)

Additional 9CFR Testing Services, currently not accredited to the ISO 17025 standard:

• Detection of viable bacteria and fungi per Title 9 of the Code of Federal Regulations (113.26)
• Detection of mycoplasma per Title 9 of the Code of Federal Regulations (113.28)
• Cell Lines per Title 9 of the Code of Federal Regulations (113.52)
• Master Seed Virus per Title 9 of the Code of Federal Regulations (113.55)
• Porcine Parvovirus Testing on Trypsin (113.53 (d), 113.47)

EMA and Ph.Eur. Testing Services

Accredited to ISO 17025 by the American Association for Laboratory Accreditation (Certificate 2880.01):

Testing on bovine serum that is used in the production of veterinary biologics for adventitious agents per Title 9 of the Code of Federal Regulations, 113.53 (c), 113.46, and 113.47 and EMA/CHMP/BWP/457920/2012 rev1, sec 7.1-7.3 and Ph.Eur. Monograph 2262 (Sections: Tests for viral contaminants, General Tests & Specific Tests).

• Bovine serum

Serological Tests

Detection of virus specific antibodies in commercial serum products.

• Bluetongue Virus ELISA
• Bovine Leukosis Virus ELISA
• Bovine Respiratory Syncytial Virus Serum Neutralization
• Bovine Viral Diarrhea Virus Serum Neutralization, type 1 and 2**
• Equine Infectious Anemia Virus Serology, ELISA or AGID
• Infectious Bovine Rhinotracheitis (OIE) Serum Neutralization**
• Vesicular Stomatitis Virus Serum Neutralization, Indiana and New Jersey**

**Accredited to ISO 17025 by the American Association for Laboratory Accreditation (Certificate 2880.01)

Custom Testing Services

Custom testing per client request may be possible. Please contact Virology Management at ahdc_virology_mgmt@cornell.edu.

• Custom bovine serum test on CHO (Chinese Hamster Ovary) cells
• Porcine Circovirus 1&2 testing
• Cell Growth testing
• Serum Inhibitory testing
• Virus Neutralization Index testing
• Bacteriophage testing
• Cloning Efficiency
• Colony Forming Efficiency (Plating Efficiency)
• Bacterial Endotoxin Testing
• Vesicular stomatitis virus testing (Indiana and New Jersey strains) on serum

Please contact Virology Management for additional information regarding these testing services at ahdc_virology_mgmt@cornell.edu.