Agilent Technologies, a global leader in life sciences, diagnostics, and applied chemical markets has announced important improvements to its line of regulated bioanalysis and bioequivalence (BA/BE) offerings.

BA/BE analysis is a critical step in the pharmaceutical and biopharmaceutical manufacturing process for the regulatory compliance and export of products in developed markets—particularly in India, which serves as a hub for many U.S. and European clinical trials.

David Edwards, Agilent Associate Vice President of Marketing said, “Bioanalytical data is essential to evaluating the safety of new drugs. Agilent offers a unique set of end-to-end solutions that are critical to India’s pharma and biopharma markets.”

Agilent improved its workflow solution to meet customers’ need to adapt to changing scientific, business, regulatory, and industry challenges – addressing many software and data security concerns. The biggest potential impact of the system for BA/BE analysis is increased productivity and reduced cost per sample. Specifically, customers can measure matrix-related effects, identify and understand the impact of metabolites, and facilitate compliance with increasing regulatory demands such as ISR, 21 CFR Part 11, and GxP.

 “The robustness of Agilent LC/MS/MS hardware provides sensitive, reproducible, and fast results in BA/BE analysis,” said Edwards.

Bharat Bhardwaj, Country General Manager, Agilent Technologies said, "Agilent has a history of innovations providing solutions with strong hardware; powerful software and complex sample preparation. Our customers in India have expressed their need for end-to-end workflow solutions, and this is what we have achieved with BA/BE analysis.  With this unique solution, man, machine and method can be used in the most efficient manner, thus providing a one-stop solution to our customers’ most critical needs.”

Agilent research shows that addressing different standards associated with testing generic medicines and meeting regulations are key priorities for pharma and biopharma lab leaders in India. With only 1 out of 10,000 drug candidates making it to market, lab managers are under more and more pressure to produce successful medicines.