Reliable Endotoxin Testing by Allele Biotech: Precision, Speed, and Trust 

Our specialized endotoxin testing service ensures the highest safety and quality standards for biomedical products, including therapeutic cells, proteins, short peptides, lipids, and small molecule chemicals. Trusted by industry leaders, Allele Biotech’s state-of-the-art testing methods deliver fast, accurate results you can rely on. With over 25 years of experience, we are happy to help resolve any questions you may have about the test criteria and can also help with failure investigations and evaluation of the manufacturing process.

What is Bacterial Endotoxin Testing?

The Allele iPSC division has dedicated capacity to steadily expand its off-the-shelf cGMP iPSC line offerings. Every quarter, we initiate reprogramming of cells from two new donors and obtain three entirely independent iPSC lines from each donor. At the current pace, Allele’s cGMP iPSC line library grows by six lines every three months, which can be adjusted to align with market demand. This commitment aims to ensure that Allele provides licensees and partners with opportunities to compare multiple lines if so desired before embarking on a lengthy and costly product development journey.

This assay is also known as the Limulus Amebocyte Lysate (LAL) test and is sometimes referred to as the pyrogen test (because bacterial endotoxins can cause a fever in mammals, including humans).

What Our Clients Are Saying:

“The endotoxin testing service provided by Allele Biotech has been invaluable to our research. Their rapid turnaround time and accurate results have consistently met our expectations. The team’s expertise and professionalism are evident in their thorough approach to sample handling and data analysis. We have complete confidence in the reliability of their endotoxin testing services and would highly recommend them to others in the field.”

–Zhao Li at Innopep

Key Features – Why Choose Allele Biotech?

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    Unmatched Accuracy

    Detects even the smallest endotoxin levels to protect your product’s safety.

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    Regulatory Compliance

    Fully adheres to FDA, ANSI/AAMI ST72:2011, EP 2.6.14, JP 4.01 and the FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers.

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    Broad Application

    Trusted for therapeutic cells, biologics, pharmaceuticals, and laboratory chemicals.

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    Quick Turnaround

    Consistently fast results to support your timeline.

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    Proven Expertise

    A dedicated team of experts ensuring thorough, reliable results.

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With Allele Biotech’s endotoxin testing, you’re partnering with a team that shares your commitment to safety and scientific excellence. 

Contact us today at info@allelebiotech.com for a consultation or to schedule your endotoxin testing and experience the reason clients confidently recommend our service!

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