9CFR and Custom Testing Services

9CFR Testing ServicesA2LA Accreditation logo

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)

EMA 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 EMEA/CVMP/743/00-Rev.2 section 4.3.3.1.

  • 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

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