Blog

You are here:
Home/
Press Room/
Blog

Posts

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.

22 Oct 19: KYMOS at CPhI Worldwide 2019 in Frankfurt

CPhI Worldwide 2019 takes place 5th - 7th November and @Kymos is sending its largest ever contingent of #experts to repeat last year's success. Covering every step of the supply chain, CPhI is the perfect place to network and Kymos is an ideal multidisciplinary partner to outsource your pharmaceutical needs.

05 Oct 19: Biologics expert Dr Carles Celma to speak at the Biosimilars and Biologics Congress

KYMOS is proud to announce that Dr Carles Celma, our Scientific Director, will be speaking at the Biosimilars and Biologics Congress in Rome on October 17-19.

04 Oct 19: What happens to batch testing and batch release after Brexit

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.

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

28 Apr 19: Quality and Equivalence of Topical Products

On October 18, 2018 the EMA published the Draft Guideline on Quality and Equivalence of Topical Products. On June 30, 2019, the period of Consultation will end and it is expected to be in force by the end of the year. The guideline clearly states that regulatory applications based in literature to demonstrate safety and efficacy should be supported by equivalence data of the formulation.

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.

29 Jan 19: Interview to Kymos CEO in Healthcare & Life Sciences Review

Joan Puig de Dou, CEO of Kymos Pharma, a Spanish analytical CRO, shares his insights in the changing dynamics of the industry and explains how remaining independent in the face of industry consolidation is a strategic priority to leverage both quality and specialization for the company’s clients.

The interview has been published online in Pharma Boardroom:

https://pharmaboardroom.com/interviews/joan-puig-de-dou-ceo-kymos-pharma-spain/

Scroll