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Mycoplasma Testing

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OVERVIEW:

Regulatory compliance mycoplasma assays to satisfy various regulations,including USDA-APHIS 9 CFR, European Pharmacopeia (EP), and United States Pharmacopeia (USP). Additionally, Mycoplasma testing of large volumes by Barile's direct culture method &

MATERIALS TESTED:

Animal Origin Products​

Cell Lines

Virus Seeds

SPECIES:
bovine

BOVINE

camelid

CAMELID

canine

CANINE

caprine

CAPRINE

cervine

CERVINE

equine

EQUINE

feline

FELINE

murine

MURINE

ovine

OVINE

porcine

PORCINE

FULL DESCRIPTION:

VMRD offers mycoplasma assays to satisfy various regulations, including:

  • USDA-APHIS 9CFR (9CFR 113.53a and 113.28)
  • European Pharmacopeia (EP), European Medicinal Agency (EMA) (EP 2.6.7, EMA) 
  • United States Pharmacopeia (USP <63>)

Additionally:

  • Large Volume Barile method mycoplasma detection assay (broth and agar method)
  • Large Volume Barile method mycoplasma detection assay (indirect culture on indicator cells)

AVAILABLE TESTS

  • Assay ID
  • Materials
    Tested
  • Regulations
    Satisfied
  • Samples
    Required
  • Test Length
    (Days)
  • Assay ID
    9C-MY-IN
  • Materials
    Tested     Serum,powder,cell lines/stocks,virus banks/lots
  • Regulations
    Satisfied     *9CFR 113.52c,113.53a
  • Samples
    Required     10 ml/1 g/6 x 1 ml aliquots
  • Turnaround 31-38
  • Assay ID
    9C-MY
  • Materials
    Tested     Serum,powder,cell lines/stocks,virus banks/lots
  • Regulations
    Satisfied     9CFR 113.52c,113.53a
  • Samples
    Required     10 ml/1 g/2 x 1 ml aliquots
  • Turnaround 31-38
  • Assay ID
    EPUSP-MY-DIR
  • Materials
    Tested     Serum,powder,cell lines/stocks,virus banks/lots
  • Regulations
    Satisfied     EP 2.6.7, USP 63
  • Samples
    Required     35 ml/5 g/35 X 1 ml aliquots
  • Turnaround 31-38
  • Assay ID
    EPUSP-MY-IND
  • Materials
    Tested     Serum,powder,cell lines/stocks,virus banks/lots
  • Regulations
    Satisfied     EP 2.6.7 and USP 63
  • Samples
    Required     5 ml/1 g/5 X 1 ml aliquots
  • Turnaround 14-21
  • Assay ID
    EPUSP-MY-IN-DIR
  • Materials
    Tested     Serum,powder,cell lines/stocks,virus banks/lots
  • Regulations
    Satisfied     EP 2.6.7 and USP 63
  • Samples
    Required     75 ml/5 g/75 X 1 ml aliquots
  • Turnaround 31-38
  • Assay ID
    EPUSP-MY-IN-IND
  • Materials
    Tested     Serum,powder,cell lines/stocks,virus banks/lots
  • Regulations
    Satisfied     EP 2.6.7 and USP 63
  • Samples
    Required     10 ml/1 g/10 X 1 ml aliquots
  • Turnaround 31-38
  • Assay ID
    LVB-MY-B&A
  • Materials
    Tested     Serum products
  • Regulations
    Satisfied     N/A
  • Samples
    Required     100ml/10g
  • Turnaround 28
  • Assay ID
    LVB-MY-IND
  • Materials
    Tested     Serum products
  • Regulations
    Satisfied     N/A
  • Samples
    Required     100ml/10g
  • Turnaround 14

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