Assay development, validation and transfer

Analytical methods are fundamental to all aspects of drug development and manufacturing. Accordingly, they require development, validation, and controls just as all other product and process development activities.

Our compendial/GLP/GMP compliance testing laboratory develops its testing methods based on the specific needs of our clients. We help clients follow a scientific and proven approach for various analysis. Our team believes in finding proper methods for superior outcomes and reliable testing. Solid expertise in molecular techniques such as PCR, qPCR, RFLP, plasmid testing or DNA genotyping give us the capability of delivering solid and quantifiable results.

If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work performed in a faster timeframe than your laboratory can handle, we are here to help. As development partners, we will design detailed protocols for method development, validation, and transfer based on the product’s phase in the drug development process.

Learn more how we can help you realize your research goals through assay development, validation, and transfer.

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Dual-labeled hydrolysis probes

Dual-labeled hydrolysis probes Dual-labeled hydrolysis probes

The technology of dual-labeled hydrolysis probes (also called TaqMan® real-time PCR probes) exploits the 5 ́-3 ́ exonuclease activity of Taq DNA polymerase to cleave the probe. TaqMan real-time PCR probes are labeled with a fluorescent dye (reporter) at the 5´ end and with a quencher at the 3´ end.

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Yeast Production Strain Cell Line Authentication by RFLP analysis

Yeast Production Strain Cell Line Authentication by RFLP analysis

Background Probiotics are defined as live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. For instance, probiotics can be used in the treatment and prevention of infections and chronic inflammatory disorders of the gastrointestinal tract. Due to their health attributes, probiotics generate considerable interest in the area of functional