Mycoplasma Testing
VMRD offers comprehensive mycoplasma testing services to meet a range of regulatory requirements and ensure the safety and quality of your biologics. Our assays are validated or verified to deliver high sensitivity for the detection of Mollicutes—including Mycoplasma species—in a variety of test articles.
We provide mycoplasma detection solutions compliant with international standards, including:
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USDA-APHIS 9 CFR (Sections 113.52c, 113.53a, and methods from 113.28)
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United States Pharmacopeia (USP 63)
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European Pharmacopoeia (EP 2.6.7)
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European Medicines Agency (EMA)
Our lab-developed methods are designed to give you the confidence and accuracy you need when testing critical products like vaccines, cell lines, and other biologics.
Why Detection Matters
Mycoplasma contamination is a serious concern in cell culture and biologics manufacturing. These contaminants can alter cell metabolism, compromise research results, and pose serious safety risks in therapeutic products. Regulatory agencies require rigorous mycoplasma testing to protect product integrity and patient safety.
Accurate mycoplasma detection helps ensure your products are free of these fastidious microorganisms, reducing risk and meeting global compliance standards, including USP 63 mycoplasma tests.
Explore Our Services
VMRD is committed to providing dependable mycoplasma testing services for veterinary and human biologics. Whether you're looking to comply with USP 63, 9 CFR, EP, or EMA guidelines, our lab has the experience and assays you can trust.
Explore the available mycoplasma detection tests listed below or contact us to learn more about our mycoplasma testing services and how we can support your compliance needs.
Mycoplasma Detection Assay
Assay Length:
28 days
Catalog Number:
9C-MY
Regulations Satisfied:
9 CFR 113.28, 113.52(c), 113.53(a)
Volume Required:
10 mL, 1 gram, 6 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
A. laidlawii, M. hyorhinis
Mycoplasma Detection Assay w/Inhibition Assay
Assay Length:
28 days
Catalog Number:
9C-MY-IN
Regulations Satisfied:
9 CFR 113.28, 113.52(c), 113.53(a)
Volume Required:
10 mL, 1 gram, 6 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
A. laidlawii, M. hyorhinis
Mycoplasma Detection Assay
Assay Length:
28 days
Catalog Number:
EPUSP-MY-DIR
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
35 mL, 5 grams, 35 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
A. laidlawii, M. gallisepticum, M. fermentans, M. hyorhinis, M. orale, M. pneumoniae and M. synoviae
Mycoplasma Detection Assay w/Inhibition Assay
Assay Length:
28 days
Catalog Number:
EPUSP-MY-IN-DIR
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
75 mL, 5 grams, 75 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay w/Inhibition Assay
Assay Length:
28 days
Catalog Number:
EPUSP-MY-IN-IND
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
10 mL, 1 gram, 10 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay
Assay Length:
14 days
Catalog Number:
EPUSP-MY-IND
Regulations Satisfied:
EP 2.6.7, USP 63
Volume Required:
5 mL, 1 gram, 5 x 1 mL
Materials Tested:
Serum, Powder, Cell Lines, Virus Banks
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay, Large Volume Barile Method
Assay Length:
28 days
Catalog Number:
LVB-MY-B&A
Regulations Satisfied:
NA
Volume Required:
100 mL or 10 grams
Materials Tested:
Serum
Pathogens Tested:
M. arginini
Mycoplasma Detection Assay, Large Volume Barile Method w/inhibition
Assay Length:
28 days
Catalog Number:
LVB-MY-B&A-IN
Regulations Satisfied:
NA
Volume Required:
100 mL or 10 grams
Materials Tested:
Serum
Pathogens Tested:
M. arginini
Mycoplasma Detection Assay, Large Volume Barile Method Indicator Cell
Assay Length:
14 days
Catalog Number:
LVB-MY-IND
Regulations Satisfied:
NA
Volume Required:
100 mL or 10 grams
Materials Tested:
Serum
Pathogens Tested:
M. arginini
Performance Testing of Trypsin Sample
Assay Length:
1
Catalog Number:
PERF-TRYP
Regulations Satisfied:
NA
Volume Required:
NA
Materials Tested:
Porcine Trypsin
Pathogens Tested:
NA
Mycoplasma Detection Assay, FDA Points to Consider, Complete
Assay Length:
28 days
Catalog Number:
PTC-MY
Regulations Satisfied:
PTC (1993) Agar and Broth Media Procedure (Part A), and Indicator Cell Culture Procedure (Part B)
Volume Required:
40 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. pneumoniae, M.hyorhinis, M. orale
Mycoplasma Detection Assay, FDA PTC Agar & Broth Procedure
Assay Length:
28 days
Catalog Number:
PTC-MY-B&A
Regulations Satisfied:
PTC (1993) Agar and Broth Media Procedure (Part A),
Volume Required:
30 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. pneumoniae, M. orale
Mycoplasma Detection Assay, FDA PTC Agar & Broth w/ inhibition
Assay Length:
28 days
Catalog Number:
PTC-MY-B&A-IN
Regulations Satisfied:
Not Required
Volume Required:
80 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. pneumonia, M. orale
Mycoplasma Detection Assay, FDA PTC Indicator Cell
Assay Length:
7 days
Catalog Number:
PTC-MY-IND
Regulations Satisfied:
PTC (1993) Indicator Cell Culture Procedure (Part B)
Volume Required:
10 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. hyorhinis, M. orale
Mycoplasma Detection Assay, FDA PTC for Viruses w/ Inhibition
Assay Length:
7 days
Catalog Number:
PTC-MY-IND-IN
Regulations Satisfied:
PTC (1993) Indicator Cell Culture Procedure (Part B)
Volume Required:
20 mL
Materials Tested:
Animal Origin Product
Pathogens Tested:
M. hyorhinis, M. orale