Bioanalysis news - Kymos Group

Diethylene Glycol (DEG) and Ethylene Glycol (EG) testing on high-risk drug components

Following several global incidents involving contaminated drug products specifically designed for children, the U.S. Food and Drug Administration (FDA) released a guidance document to address the potential danger of diethylene glycol (DEG) and ethylene glycol (EG) contamination in different pharmaceutical components. These incidents occurred across seven countries between 2022 and 2023 and have raised the (...)

By Carles Celma|2024-08-29T11:22:47+02:00July 20th, 2023|CMC, News|Comments Off

Kymos and Prolytic are CIR certified

In addition to Kymos, which has been CIR certified for quite some time, our German subsidiary Prolytic has been approved a CIR certification as well. Now your R&D activities (from Early Phase up to Phase IV projects) performed at Kymos and Prolytic are eligible to CIR. You can recover up to 30% of the amount (...)

By Joan Puig de Dou|2024-08-14T10:50:00+02:00January 31st, 2023|Kymos Group, News|Comments Off

Prolytic and Aeterna Zentaris – 20 years of improving human health together

For almost 20 years, Kymos’ German subsidiary Prolytic has accompanied Aeterna Zentaris in its development of pharmaceutical and diagnostic products. Katrin Dorfmeyer, Head of Chromatography, at Prolytic, and Dr. Michael Teifel, CSO at Aeterna Zentaris, shed light on the interesting project of the growth hormone secretagogue macimorelin (Macrilen, Ghryvelin) which they have been working (...)

By Joan Puig de Dou|2024-08-14T10:53:07+02:00March 22nd, 2022|Kymos Group, News|Comments Off

Kymos and ISGlobal join efforts to STOP parasitic diseases in Africa

“Kymos is a group with the highest ethical standards. This is not a PR statement but our day-to-day philosophy” Dr. Carles Celma, Scientific Director at Kymos stresses. “It was our pleasure to take an active role in the STOP project for the treatment of intestinal parasites in developing countries as soon as ISGlobal approached us.” (...)

By Joan Puig de Dou|2024-08-14T10:49:41+02:00November 30th, 2021|Kymos Group, News|Comments Off

Kymos and Prolytic merge to become Kymos Group

With the German CRO joining the European group, Kymos will strengthen its activity in the biologics and advanced therapies market and broaden its services portfolio while offering three local sites in Europe Barcelona, Spain, and Frankfurt, Germany, September 28, 2020 – Kymos S.L. and Prolytic GmbH announce today the completion of a successful strategic (...)

By Joan Puig de Dou|2024-08-14T10:50:29+02:00September 28th, 2020|Kymos Group, News|Comments Off

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. (...)

By Joan Puig de Dou|2024-08-14T11:16:45+02:00October 4th, 2019|CMC, News|Comments Off

Kymos approval as reference lab for biologics in Lebanon

The Ministry of Public Health of the Republic of Lebanon has approved KYMOS as Reference Laboratory for Biological Drug Tests. This is an important acknowledgement to the efforts undertaken by KYMOS to develop innovative analytical methods for biosimilars and biotechnological products. KYMOS has experience in method development, validation and testing of different biosimilars like infliximab, trastuzumab, pelgastrim or omalizumab; polisaccharides (...)

By Joan Puig de Dou|2024-08-30T12:04:43+02:00March 2nd, 2018|Kymos Group, News|Comments Off

New Cosmetics Regulation in Spain

Cosmetics were widely regulated in the framework of the European Union through the Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009 on cosmetic products. The aim of this regulation was: i) strengthened safety requirements, ii) introduction of “responsible person” position, iii) centralized notification of cosmetic products marketed in the EU, (...)

By Joan Puig de Dou|2024-08-14T10:53:55+02:00March 2nd, 2018|News|Comments Off

CRO Market Growth

The global CRO market value is expected to exceed $32 billion in 2017 and reach $45 billion by 2022, according to a report by Grand View Research, with growth attributed to greater R&D spend, M&A activity, as well as government contracts with CROs. The role of CROs in helping pharma and biopharma firms address today’s (...)

By Joan Puig de Dou|2024-08-14T10:41:26+02:00September 17th, 2017|News|Comments Off