26 Feb 20

Bioanalysis: Harmonization, Experience and Good Practices

The importance of ICH M10 harmonization
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. 

10 Dec 19

Dr Lluïsa Garcia advises on how to manage N-nitrosamine impurities in sartans

“Face Nitrosamine uncertainty with a flexible analytical CRO and a full risk assessment”
Dr Lluïsa García, Kymos Pharma Services

There has been much attention surrounding the discovery of N-nitrosamine impurities in blood pressure medicines known as sartans. We explain how this situation has arisen and interview our expert, Dr Lluïsa García, PhD in Organic Chemistry, Co-Founder and COO at KYMOS about current concerns and how to tackle them.

17 May 19

Host Cell Proteins Analysis

The development and validation of a process specific assay for host cell proteins (HCP) determination in therapeutic recombinant proteins should follow the specifications contained in monograph 2.6.34 of the European Pharmacopeia in a step by step approach:

1. Production of the HCP antigens

Capillary electrophoresis PA800
04 Mar 19

Electrophoresis in Quality Control of Biologics

Electrophoresis is an analytical technique widely used for purity determination and identification of therapeutic proteins. This technique is based in the migration of the proteins under an electrical field according their electrophoretic mobility. Depending of the type of the electrophoresis, different quality attributes of the protein can be measured. Sensitivity, robustness and throughput will depend of the format used, being the classical flat/vertical gel formats displaced by the newest capillary formats due to their inherent advantages.