30 Mar 20

Elemental impurities analysis: anticipating our clients’ needs before they need to ask

The European Pharmacopoeia implemented the ICH Q3D guideline in June 2017, ruling the need to assess for the presence of potential elemental impurities in all drug products. Now guidelines will expand to also cover products for veterinary use. 

We talk to our expert in elemental impurities, Gemma Solsona, as she updates us on the latest developments in the industry. Gemma has almost a decade of experience working in the pharmaceutical industry and leads a department that is historically tied to regulatory changes.

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