Contamination Testing Service

Q: What is the main advantage of using monocyte activation testing over the traditional rabbit pyrogen test?

MAT is an in vitro test that offers greater precision and often higher sensitivity than the traditional rabbit test, while being more humane and providing a faster turnaround time. It allows for the detection of non-endotoxin pyrogens, providing a more robust safety profile.

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.

Introduction What We Can Offer How We Can Help Why Creative Biolabs Customer Reviews FAQs Contact Us Related Services

Introduction of Contamination Testing

Contamination testing is the scientific discipline dedicated to detecting, identifying, and mitigating the presence of undesirable biological or chemical substances in therapeutic products and manufacturing environments. This is a primary requirement under recognized quality assurance guidelines. By employing advanced methodologies like genomic sequencing (HTS) and mass spectrometry (MS), contamination testing verifies product integrity and assures end-user safety and product integrity, directly supporting the development and commercialization of safe, high-quality manufacturing processes.

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Fig.1 Implementation of a contamination control strategy. (Creative Biolabs Original) Fig.1 Safeguarding biologics through contamination testing.

What We Can Offer

Microbiology Testing

Services	Descriptions
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 their 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 environment. These test methods can also be developed and consulted according to specific products.

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

Viral Safety Assays

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

In vivo detection	Cell-based in vitro assay
Mouse, hamster, and rat antibody production test Unscheduled virus testing, including specific test methods for detecting vaccines	Foreign factor determination Retrovirus detection test XC plaque assay S + L-focus measurement Transmission electron microscope (TEM) PCR-based reverse transcriptase (PBRT) assay

How Creative Biolabs' service Can Assist Your Projects

Core steps of contamination testing. (Creative Biolabs Original)

Why Choose Us

Accreditation and Authority

Our laboratories hold IEC 17025 accreditation and adhere strictly to all applicable ASTM standards and global pharmacopoeias, providing scientifically rigorous and auditable data.

Next-Generation Sensitivity

We utilize high-resolution techniques like ICP/AES, ion chromatography (IC), and mass spectrometry (MS) that provide detection limits down to the ppb range, crucial for elemental and ionic impurities.

Advanced Biological Assays

We employ modern in vitro assays like monocyte activation testing (MAT), offering a faster, more ethical, and often more sensitive alternative to traditional in vivo pyrogenicity testing.

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Customer Reviews

Exceptional Specificity
Using Creative Biolabs' contamination testing for our process equipment cleaning validation has significantly improved the confidence in our CIP cycle design. The IC analysis provided a highly specific quantification of residual ionic compounds that UV-Vis methods completely missed. - C. A****on.
Quality Confidence
The adoption of the monocyte activation test for our injectable product, facilitated by Creative Biolabs' method transfer, substantially streamlined our QC release process. This in vitro approach is exactly what the quality control field is pushing for. - J. F**ds.

FAQs

Is next-generation sequencing enough to satisfy all viral contamination requirements?

NGS is an extremely powerful tool for unbiased, broad-range detection of novel or unexpected viruses. However, quality control oversight still requires confirmation using traditional, targeted compendial assays for known agents. We recommend using NGS complementary to assays like our viral safety testing for a truly comprehensive risk mitigation strategy.

What is the main advantage of using monocyte activation testing over the traditional rabbit pyrogen test?

MAT is an in vitro test that offers greater precision and often higher sensitivity than the traditional rabbit test, while being more humane and providing a faster turnaround time. It allows for the detection of non-endotoxin pyrogens, providing a more robust safety profile.

How to Contact Us

From routine pre-clinical batches to routine bulk harvest testing of clinical and marketed batches, contamination testing helps ensure the safety of biologics before release for use in animals and humans. Our contamination experts are standing by to discuss your project's specific requirements. Please feel free to contact us for more information about our services.