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We are pleased to announce that Dr Luca Gramaccioni, General Site Manager at Kymos Italian Site Pharmaprogress, has been asked to share his analytical experience on nitrosamines in yet another webinar – this time the AFI Symposium 2021 hosted by the Associazione Farmaceutici Industria on September 24th. In anticipation for the event, he and Dr Massimo Bartolacci, Pharmaprogress’ nitrosamine expert, share their insight into how regulatory requirements have evolved since the classification of nitrosamines as probable human carcinogens back in 2019: 

An important function of the skin is to protect the body from the environment, and it is normally a very effective barrier against external substances. In some cases, however, penetration of active substances (API) into the skin is desired to provide a therapeutic effect. Hence, manufacturers of pharmaceutical topical products must test how well their products penetrate the skin. Dr. Carles Celma, Scientific Director at Kymos, explains how such a task can pose a few challenges: 

Not many companies can celebrate 20 years of collaboration after reporting their best revenues ever and having become a successful multinational group, but contract research organization KYMOS and top biopharmaceutical innovator PHARMAMAR are just going to do that. How the evolution of pharmaceutical outsourcing over the last two decades has changed the trajectory of these two old-time partners is a story worth reading. Kymos’ Co-Founder and Site General Manager Dr. Lluïsa García takes a moment with PharmaMar’s Manager of Nonclinical Toxicology and Pharmacology Dr.

Luca Gramaccioni, Site General Manger at Kymos Pharmaprogress, was a guest speaker at the 40th AEFI symposium last May 11th. He presented “Nitrosamines: How to face the analytical challenges for step 2” at a Round Table alongside other experts from AEMPs, AZIERTA and AGILENT. 
In his presentation Dr. Gramaccioni evaluated the advantages of outsourcing non-routine testing of N-nitrosamine impurities, data requirements from regulatory authorities and showed three real-life case studies taken from daily practice.

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 to ICH zones II, IVb as well as other customized conditions.

KYMOS recently had the pleasure to lead a TV program series about the importance of outsourcing service providers like ourselves in the provision of medicines. Since the outbreak of COVID-19 the general public is paying much more attention to the biopharmaceutical industry and the challenges of conducting drug development, manufacturing, quality control and supply in the midst of a global pandemic.

Kymos celebrates the recent purchase of two new API-6500 plus instruments, the most sensitive in the market, to boost our bioanalytical capabilities for small molecules in our Frankfurt und Barcelona sites. Together with our third API-6500 coupled to an Agilent UHPLC, two high-sensitivity APIs 5500 connected to a Waters UPLC Acquity, six API-4000 and one API-3200 (all triple SCIEX quadrupoles) we are now capable to process more than 31,000 bioanalytical samples per month.

The new COVID-19 vaccine developed by Pfizer/BioNTech was approved by the EMA last December and now Moderna’s is following suit. Both are based on mRNA technology and represent a very different type of vaccine compared to traditional ones. While the general public is just beginning to discover mRNA technology, Dr. Meike Saul is an expert in RNA research and has worked with Prolytic GmbH for many years. She was invited to give us a better insight into the exciting world of RNA.