Categories

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.

Useful links
Recommended products
Kit for isolation of DNA from body fluids

Kit for isolation of DNA from body fluids Kit for isolation of DNA from body fluids

The DNA extraction kit includes DNA purification step and enables achieving highly pure genomic DNA from samples of whole blood, serum, plasma, buccal swab and urine. Moreover, viral DNA can be efficiently isolated from these types of samples as well. High DNA yields, reproducible results and fast working method are guaranteed.

More
Recommended articles
CRO case studies

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

More