Blog

Now more than ever, immunology is a hot topic as we face the numerous challenges of the COVID19 pandemic. The world is patiently awaiting new therapies and vaccines to combat this disease in hopes of returning some sense of normalcy to our lives. 

KYMOS’ immunology expert, Dr. Carles Morte, shares his outlook on the future of promising new gene- and cell-based therapies and monoclonal antibodies developed against viral and other diseases. We talk to him about the technical evaluation required as the therapeutic target turns to the ever-so-complex immune system. 

Introduction

Our quality control manager and co-founder of Pharmaprogress, Dr Luca Gramaccioni has nearly two decades of experience in mass spectrometry. Here, he talks about the latest Nitrosamine deadline extension and our ahead-of-the-curve screenings. 

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. 

“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.

Kymos complies with FDA & EMA inspections as well as GLP, GMP and GCP standards. In particular, as a GMP certified CRO, we take the responsibility tosupply manufacturer authorisation for quality control purposes. In this guide, Kymos helps outline the current situation of Brexit and what this means for batch testing and batch release after Brexit.