Safety Tests for Pharmaceutical Products

In order to distribute a new pharmaceutical product on the market, all applicable regulatory standards for safety and quality must be met. Mérieux NutriSciences | Pharma & Healthcare offers a complete portfolio of GxP-compliant studies and laboratory analyses to ensure the safety of APIs, excipients, and finished products.

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Complete List of Technologies

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Safety Tests for Pharmaceuticals: Our Lab

In the Cell Biology, Toxicology and Virology Lab, we specialize in testing for viral and genotoxic contaminants, ensuring the safety and efficacy of biologic products. Our virology and genotoxicity experts use advanced cell culture techniques to detect viral agents and genotoxic impurities, providing critical data for your product’s safety profile.

Cell Biology

Our Cell Biology section is equipped with advanced cell culture techniques and molecular biology tools.

Cell culture: maintenance and manipulation of various cell lines for experimental purposes.
Microscopy: advanced imaging techniques, including fluorescence microscopy for detailed cellular visualization.

Toxicology

Our Toxicology section is dedicated to evaluating the safety of pharmaceutical compounds. We conduct rigorous testing to identify potential toxic effects and ensure that products meet safety standards.

In vitro toxicology: cell-based assays to assess cytotoxicity, genotoxicity, skin sensitization, and other toxicological endpoints.
Regulatory Compliance: ensuring all studies meet GLP standards and regulatory guidelines.

Virology

Our Virology section focuses on the study of viruses and their survival after interaction with disinfectants or manufacturing process steps.

Virus culture: propagation and maintenance of various viral strains for research and testing.
Virus detection: cell-based infectivity assays are performed at our site with appropriate controls and replicates to ensure adequate sensitivity and reproducibility of results.

By integrating these capabilities and maintaining rigorous quality standards, our Cell Biology, Toxicology, and Virology Lab is essential in the development and safety assessment of innovative pharmaceutical products.

Safety Tests for Pharmaceutical Products:

Fine chemicals
Active ingredients
Isolated impurities

Genotoxicity Safety Tests

Bacterial reverse mutation test (Ames test) – OECD 471 (in vitro test). The Ames test evaluates the mutagenic potential of chemical compounds and helps identify potential carcinogens by determining whether a substance can cause genetic mutations. The test is conducted according to OECD Guideline 471, ensuring standardized procedures and reliable results.
Mammalian cell micronucleus test – OECD 487 (in vitro test). It detects the genotoxic potential of chemical substances by measuring the formation of micronuclei in the cytoplasm of interphase cells and identifies substances that cause chromosomal damage, which is indicative of genotoxicity. The test is conducted in accordance with OECD Guideline 487, ensuring consistency and accuracy in the assessment.
Mammalian cell gene mutation test using thymidine kinase gene – OECD 490 (in vitro test). It detects gene mutations in cultured mammalian cells, assessing a substance’s potential to cause mutations, contributing to the overall genotoxicity evaluation. The test follows OECD Guideline 490, ensuring that the methodology and results are standardized and reproducible.

Other safety tests are available in our toxicology lab for cytotoxicity, toxicity, sensitization, corrosion, and irritation.

Viral Clearance

Ensuring Safety in Biopharmaceuticals & Medical Devices

At Mérieux NutriSciences | Pharma & Healthcare, we understand the critical importance of viral safety in the biopharmaceutical and medical device industries. Our Viral Clearance services are designed to ensure that your products are free from viral contamination, safeguarding patient safety and complying with strict regulatory standards

Why Viral Clearance is Essential

Biopharmaceutical products, such as blood derivatives, monoclonal antibodies, and recombinant proteins, often originate from living cell cultures or animal tissues. This raises the potential risk of viral contamination, which can be detrimental to both product integrity and patient health. Medical devices utilizing materials of animal origin, such as heart valves or collagen gels, also face similar risks.

Viral clearance studies are indispensable in verifying the viral safety of these products before clinical trials and commercial launch. They help in identifying and mitigating viral risks, ensuring that the final product is safe for use.

Comprehensive Viral Clearance Process

Our virology department is equipped to carry out rigorous Viral Clearance studies, assessing the ability of your manufacturing processes to inactivate or remove viral contaminants. Here is how we ensure the safety of your product:

1. Viral clearance studies:

We design tailored viral clearance studies that simulate your full-scale manufacturing processes on a smaller scale.
Critical process steps like acid/base treatments, heat treatments, filtration, and solvent/detergent treatments are tested for their efficacy in inactivating or removing viruses.

2. Model viruses:

We use a variety of model viruses that resemble potential contaminants, testing the robustness of your processes across different virus types.
This includes enveloped and non-enveloped viruses, with both RNA and DNA genomes, ensuring comprehensive safety validation.

3. Scaling Down for validation:

Our scaled-down studies mimic the actual production environment, ensuring that results are reliable and applicable to full-scale operations.

4. Quantitative infectivity assays:

We perform precise infectivity assays to determine the reduction factor (RF) of viruses at different stages, ensuring that the cumulative RF meets or exceeds regulatory requirements.

Adhering to International Standards

Our methodologies align with global guidelines and standards, including ICH Q5A, EMEA/CPMP, and ISO 22442-3. This ensures that our studies are recognized and accepted by regulatory authorities worldwide, facilitating smoother approval processes for your products.

Commitment to Quality & Safety

At Mérieux NutriSciences | Pharma & Healthcare, we are dedicated to providing you with reliable and comprehensive viral clearance services. Our team of experts collaborates closely with you to design and execute studies that meet your specific needs, ensuring that your products are both safe and compliant.