Contamination Testing

From routine pre-clinical batches to routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of biologics prior to release for use in animals and humans, which is a key part of the Regulatory Document Chemistry and Manufacturing Control (CMC) regulatory.

Creative Biolabs offers a wide range of contamination testing for the detection of mycoplasma and bacterial contaminants, as well as in vivo, in vitro and biochemical viral assays. Our experts work with you to identify sources of contamination and design available and customized testing solutions tailored to your specific needs. After that, we can work with you to conduct new quality control checks in batch testing, and optimize product development methods and raw material analysis to minimize future safety issues.

Creative Biolabs' Expertise

Microbiology Testing

  • Bioburden: Designed to determine the number of viable aerobic microorganisms, which in turn determines the sterilization dose required for sterility testing
  • Endotoxin Testing: In vitro bacterial endotoxin testing, including gel clots (a qualitative analysis) and dynamic turbidity and color development methods, which are quantitative analyses
  • Microbial Limit Test: This test is primarily designed to allow quantitative counting of bacteria and fungi that grow under aerobic conditions.
  • Preservative Efficacy Test: If the formulation itself does not have sufficient antimicrobial activity, an antimicrobial preservative can be added to the pharmaceutical formulation.
  • Antibiotic Test: Follows the specifications of EP and USP and evaluates the efficacy (or activity) of the antibiotics by its inhibition of microorganisms.
  • Environmental Monitoring: For companies with various levels of on-site clean rooms

Mycoplasma Contamination Testing

Cell substrates used in biological agents must be demonstrated to be free of foreign factors including mycoplasma. Mycoplasma contamination of cell lines can affect cell growth in culture and also affect biomolecule production. Mycoplasma testing services:

  • Quantitative fluorescence PCR (QF-PCR)
  • Detection of mycoplasma by large volume
  • Mycoplasmastasis
  • Spiroplasma QF-PCR
  • Mycoplasma clearance study
  • Follow PTC, EP, JP or USP agreements
  • EP / USP Coordination Agreement
  • EP / USP / JP Coordination Agreement
  • EP / USP / PTC Coordination Agreement

Sterility Testing

Creative Biolabs provides sterility testing in accordance with USP and EP regulations. Bulk or final products are sterility tested by direct inoculation or membrane filtration methods and can be performed in an isolator or clean room environments.

Direct inoculation of the medium for sterility testing:

  • Detection of aerobic and anaerobic microorganisms

Membrane filtration sterility test:

  • Sterile closure
  • Simultaneous detection of multiple test samples
  • Determination of aerobic and anaerobic microorganisms

These test methods can also be developed and consulted according to specific products.

Viral Safety Assays

Creative Biolabs offers a range of in vivo, in vitro and biochemical viral safety analyses. You can select and customize analysis to meet your specific concerns and needs, ensuring that you have the right test plan for your product.

In vivo detection

  • Mouse, hamster and rat antibody production test
  • Unscheduled virus testing, including specific test methods for detecting vaccines

Cell-based in vitro assay

  • Foreign factor determination
  • Retrovirus detection test
  • XC plaque assay
  • S + L-focus measurement
  • Transmission electron microscope (TEM)
  • PCR-based reverse transcriptase (PBRT) assay

Feel free to contact us for project quotations and more detailed information.

For lab research only, cannot be used for any clinical use.

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