Bioanalysis: Harmonization, Experience and Good Practices

Our head of Bioanalysis, Digna Tost has 30 years’ experience working in bioanalysis solutions. Here, she comments on the current ICH harmonization of bioanalytical global guidelines and the added value of having a solid team and upholding good practices.

The International Council of Harmonisation’s (ICH) M10 minutes have been released to improve consistency of bioanalytical data and address diverging standards across different parts of the world. With bioanalysis becoming more internationalized, it is important to coordinate regulatory guidelines. Here Digna Tost gives advice on how to comply on a global level:

“In bioanalysis global regulation is a start but good practice makes the difference,” she states. 

Both the monitoring of regulatory compliance by each country’s authority and its execution by CRO are challenging due to the differences among countries. Regulatory agencies have rejected projects due to inaccuracy on multiple occasions, so it is important to choose the right company when considering bioanalysis.

Our Bioanalysis solutions
At KYMOS, Digna and her well-established bioanalysis department partner up with clients to provide world-class bioanalysis at an expert level. With combined multidisciplinary experience, Digna’s team understands the full pharmaceutical manufacturing process from pre-clinical and clinical phases to final approval and post-marketing studies.

The ICH M10 guideline is expected to be adopted in November 2020 to provide clear guidelines on achieving bioanalytical analysis. If you want to improve the quality, consistency and reliability of bioanalytical data or regulatory support, Digna recommends looking at the minutes of the latest ICH assembly or contacting Kymos on +34 935 481 848.

Click here to read more about our bioanalysis solutions for small molecules and biologics and biosimilars.