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Bionique Testing Laboratories, Inc.

1 Order Completed
Saranac Lake, New York, US

About Bionique Testing Laboratories, Inc.

For over 28 years, Bionique Testing Laboratories has been a trusted partner and global leader of Mycoplasma Testing Services for the life science industry. We offer the full breadth of GMP services from the Lot & Final Drug Product Release Testing according to USP <63>, FDA PTC & EP 2.6.7. to Real-Time PCR assays. Our service portfolio and depth of expertise enables us to support our clients’ needs from concept through clinical trials to commercialization for biopharmaceutical and cell therapy products. Our capabilities extend to successful method development and validation inclusive of rapid microbiological methods to generate real time results. Bionique stands ready to provide the highest quality of mycoplasma testing services to ensure the integrity and biosafety of your therapeutic products. Mycoplasma Testing Solutions for: • Cell and Gene Therapy Products • Clinical Trial Materials • Biopharmaceuticals • Master and Working Cell Banks • Raw Materials • Vaccines cGMP compliant, FDA-registered facility

Certifications & Qualifications

FDA Inspected GMP

Diversity Certificates

Small business

Our Services (33)


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Mycoplasma Testing

Price on request

M-1400 Harmonized USP <63> Mycoplasma Test

Bionique’s M-1400 Harmonized USP <63> Mycoplasma test was designed to comply with USP chapter <63> Mycoplasma Tests, European Pharmacopoeia (Ph. Eur.) chapter 2.6.7 Mycoplasma, and the United States FDA’s 1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (PTC) requirements. This assay may be applied for testing tissues and cell cultures used to produce test articles, digest broth, or any material in which mycoplasma contamination is suspected.


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qRT-PCR

Quantitative reverse transcription polymerase chain reaction
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Real Time qPCR with Broth Enrichment

We have optimized the MycoSEQTM Real-Time PCR Detection Assay and combined this with a short enrichment to provide exceptional sensitivity for in-process testing and the ability to distinguish viable contaminations from non-viable. Our in-depth knowledge and experience with these technologies allows us to offer a full spectrum of validation and consultancy services to expedite the implementation of a rapid method for the detection of mycoplasma.

At Bionique our goal is to meet your need for rapid and reliable mycoplasma testing. Whether you are looking for a contract laboratory to process your routine testing submissions or work closely with you to qualify and/or validate an alternative method, we can help.


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Batch Release Testing

Price on request

M-700 FDA Points to Consider Method

This test satisfies the FDA Points to Consider for the Mycoplasma testing of Cell Cultures and Biologicals derived from cell substrates. The procedure is recommended for each lot of product harvest concentrate and the master cell banks, working cell stocks and cell substrates used for the manufacturing of these products.

M-800 Mycoplasma Test for Human Vaccines and Biologicals Compliance with 21 CFR 610.30

This test is intended for Mycoplasma testing of Vaccines and Biologicals for human use in compliance with 21 CFR 610.30 Subpart D - Test for Mycoplasmas. Bionique enhances the regulatory required 28 day direct culture based test by incorporating the indicator cell culture procedure within this service.

M-1000 Mycoplasmastasis Validation Study

Bionique® offers Mycoplasmastasis studies to validate our M-700 or M-800 Assay for an individual test article. The qualification study is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within our assays.

M-1400 Harmonized USP <63> Mycoplasma Test

The purpose of the M-1400 Mycoplasma Test is to detect the presence of agar cultivable and non-cultivable mycoplasma species in the test article.

M-1450 Inhibition Testing for the Harmonized USP <63> Mycoplasma Test

The M-1450 Test is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within the Bionique's Harmonized USP assay.


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Raw Material Testing

Price on request

M-155 DNA Fluorochrome Staining Assay with Indicator Cell Line for Sera Products

This test is designed for the Mycoplasma screening of Serum products. The service consists of the inoculation on an indicator cell line followed by the performance of DNA fluorochrome staining assay. The enrichment component of this method enhances detection of non-cultivable Mycoplasma species.

M-300 Large Volume Barile Method

This test is designed for the mycoplasma testing of Sera, Media or Bioproducts by the direct culture technique described in the Large Volume Barile Method. Bionique enhances the method by utilizing three (3) mycoplasma media formulations to maximize detection of potentially fastidious cultivable Mycoplasma species. (GMP service)

M-350 Large Volume Barile Method with DNA Fluorochrome Staining Assay

This test consists of the Large Volume Barile Method (M-300 testing service) with the addition of the Indicator Cell Culture procedure and DNA fluorochrome staining assay (M-155 testing service). Advantages of this combination approach developed in this testing service include detection of both the cultivable and non-cultivable Mycoplasma species...

M-1400 Harmonized USP <63> Mycoplasma Test

The purpose of the M-1400 Mycoplasma Test is to detect the presence of agar cultivable and non-cultivable mycoplasma species in the test article.

M-1450 Inhibition Testing for the Harmonized USP <63> Mycoplasma Test
The M-1450 Test is designed to determine the presence or absence of product-specific inhibition of mycoplasma growth within the Bionique's Harmonized USP assay.


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Project Management

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Assay Development

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Formulation Services

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Chemistry and Materials

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Product Development, Testing, and Packaging

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Testing of Cell Lines

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Biology

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Product Testing Services

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Validation, Services

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Sterility Testing

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Contract Services Directory

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Microbiology Testing

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Microbiology Quality Control

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Contract Research

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Biological Testing

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Analytical Method Validation

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Analytical Method Development

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Analytical Chemistry Services

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DNA Services

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DNA Services


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Nucleic Acid Services

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Nucleic Acid Services


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Biochemistry & Molecular Biology

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Biochemistry & Molecular Biology Services


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Product Quality Control

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Cells and Tissues

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Material Testing Services

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Material Characterization Services


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PCR

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PCR Services


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Potentially delete

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Potentially delete Services


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Business Development, Marketing & Operations

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Business Development, Marketing & Operations Services


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Business Operations and Logistics Support

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Business Operations and Logistics Support Services


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Manufacturing Services

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Manufacturing Services


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DD

Dane DeGrace

Business Manager
SP

Steve Pemberton

Vice President of Business Development

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