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Injectable Small Molecules

Cell and gene therapies and biopharmaceuticals justifiably capture attention for their immense potential to transform human health. But did you know that in 2023, 62% of FDA-approved drugs were small molecules? In fact, 34 of the 55 new drug approvals fell into this category.

Whether you're manufacturing traditional small molecule therapeutics, vaccines, or GLP-1 derivatives, bioMérieux is your trusted partner in prioritizing product and patient safety.

Peace of Mind for What Matters

We can help you stay compliant with regulatory guidelines, enabling you to confidently deliver life-changing medicines to those in need — efficiently and sustainably.

   

   

Our Product Offering For Injectable Small Molecule Quality Control Testing

  • 3P® ENTERPRISE

    Em-power the Future

    Bridging the gap between standard processes and automation, 3P® ENTERPRISE transforms the future of environmental monitoring in the pharmaceutical industry. From sampling to trending, take control with an end-to-end, fully digitalized and automated workflow. Increase efficiency and ensure your products are safe and compliant with an innovative environmental monitoring system.

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  • 3P® SMART PLATES

    Em-brace Traceability

    When conducting routine microbial surveillance of pharmaceutical manufacturing facilities, accuracy can empower you to make smarter decisions, meaning products, employees, and patients remain safe, and your business operates in compliance with regulatory guidelines. When it comes to Environmental Monitoring (EM), state-of-the-art culture media is a necessity when you’re counting on traceability and definitive results.

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  • 3P® CONNECT SOFTWARE

    Em-body Connectivity

    3P® CONNECT is designed to secure sample traceability and collection of your Environmental Monitoring (EM) data to ensure reliable decision-making and optimize process efficiency. This comprehensive system includes dedicated software and  performant pre-barcoded 3P® SMART PLATES. Skipping the traditional paper-based process for EM decreases risk of errors and saves time during the entire production process.

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  • 3P® Support & Services

    Your Vision, Our Mission

    As your partner, we’re committed to providing you with the assistance and services you need to make implementation easier and faster.

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  • BIOBALL® Standardized Strains

    Microbiological Quality Control

    BIOBALL® is a small water-soluble ball containing a precise number of microorganisms that delivers accuracy and precision, batch after batch.

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  • ENDONEXT™

    The Evolution of Endotoxin Testing

    ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.

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  • ENDONEXT™ Automated with Tecan

    We have paired our ENDONEXT® rFC-based endotoxin testing solutions with the Tecan Fluent® automation platform. 

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Contact Our Experts

Fill out the short form below and a member of our team will be in touch to discuss your current testing process and how we can partner together to optimize your workflow.

Resources

Continue Your Journey

Image Whitepaper - New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System.

White Paper

New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System

To efficiently control the quality of pharmaceutical products, manufacturers must monitor for potential microbial contaminants. This is typically performed using irradiated culture media in Petri plates throughout the production process, especially within clean rooms, isolators and controlled production environments.

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Scientific Article

Why Pharmaceutical Developers Use BIOBALL® 

The intellectual properties and proprietary methodologies used in making BIOBALL® redefine what was considered as quantitative microbiology and make it simple to get precise and accurate quantitative microbiological quality controls batch after batch.

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eBook

Your Quick Guide To Better Endotoxin Testing

Most new users of Limulus-based tests want to review basic knowledge around endotoxin and endotoxin detection, while more experienced users want to review the practical aspects of testing with an eye toward meeting ever-changing regulatory expectations. They also want to generate laboratory dialog as to how to apply basic principles and “best practices” to increasingly complex tasks including method development, verification, validation and the routine testing of various drug types. This material can also serve as a supplement to a user’s basic endotoxin training.
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