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New FDA Draft Guideline for Oligonucleotide Therapeutics

In June 2022 the FDA published a draft version of a new guideline about “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics”. The guideline provides recommendations to assist the industry in the development of oligonucleotide therapeutics. This poses new challenges for oligonucleotide therapeutics developers and manufacturers. Maria Fauth, Department Manager Oligonucleotides at Kymos, explains (...)

By Carles Celma|2024-08-30T11:59:18+02:00October 28th, 2022|Bioanalysis, CMC|Comments Off

Elemental Impurities: New regulations for human and veterinary pharmaceuticals and cosmetic products

Elemental impurities in pharmaceutical but also cosmetic products are increasingly receiving the attention of the authorities. New limits are being defined constantly and it is essential to always be up to date with the latest regulations. Gemma Solsona, Head of Department for Elemental Impurities, informs about the most important recent regulatory developments: “Currently, several changes (...)

By Carles Celma|2024-08-14T10:45:53+02:00July 25th, 2022|CMC|Comments Off

Dissolution testing for all dosage forms

In recent months, we unfortunately had to turn down repeated requests for dissolution tests for which we would have needed the Dissolution USP 4 CE 7smart device. This was neither satisfactory for our customers nor for us. We have taken this situation seriously and ated accordingly: A brand-new Dissolution USP 4 CE 7smart device (...)

By Joan Puig de Dou|2024-08-14T10:42:31+02:00May 10th, 2022|CMC|Comments Off

Microbiology: Adding Value to a Full Service

At Kymos, recognized leader in comprehensive laboratory testing, we are privileged to have an entire department dedicated to microbiological testing for sterile and non-sterile API’s and drug products. Karen Reboulaz, Manager of the Microbiology Department, shares with us a deeper insight in her team’s work and the reasons why a significantly increasing number of (...)

By Joan Puig de Dou|2024-08-14T10:53:29+02:00November 3rd, 2021|CMC, Kymos Group|Comments Off

Analytical Development & Validation: The Entry Gate Of Your Project

Rosa Latorre, PhD in Analytical Chemistry and Director of the Analytical Development and Validation Department at Kymos, started her career in big pharmaceutical multinationals such as Merck, Grifols and Ipsen before joining Kymos - which in 2009 was a much smaller CRO than today - to provide analytical services for those global players she (...)

By Carles Celma|2024-08-14T10:36:44+02:00October 7th, 2021|CMC|Comments Off

Your Stability Studies in Safe Hands

In recent years Kymos has experienced a surge in demand from drug manufacturers in need of a reliable outsourcing partner for their stability programmes. Kymos responded by making a major investment to build new climatic chambers in their sites in Spain and Italy to reach today’s 100m³ of storage capacity for all conditions corresponding (...)

By Carles Celma|2024-08-14T11:17:11+02:00April 26th, 2021|CMC, Kymos Group|Comments Off

Batch Testing and Release: Life after Brexit

We at KYMOS and ASPHALION are long-time partners in providing analytical and regulatory services to international pharma and biotech sectors. Our testimony goes beyond the conventional “CRO trading with UK clients” to overcome internalization barriers. Our respective services are part of a complex international supply chain that makes the effects of Brexit more visible (...)

By Joan Puig de Dou|2024-08-14T10:37:37+02:00November 16th, 2020|CMC|Comments Off

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 (...)

By Joan Puig de Dou|2024-08-14T10:45:05+02:00May 30th, 2020|CMC|Comments Off

Nitrosamine screenings: broaden the scope today, reduce costs tomorrow

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. Regulatory Authorities have recently extended the Nitrosamines risk assessment deadline until October 1st 2020, giving our clients additional time to (...)

By Carles Celma|2024-08-14T11:11:16+02:00April 21st, 2020|CMC|Comments Off

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, (...)

By Joan Puig de Dou|2024-08-30T12:02:17+02:00December 10th, 2019|Bioanalysis, CMC|Comments Off