Post

26Apr21

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 to ICH zones II, IVb as well as other customized conditions. Damarih Valdes and Francesco Spadoni, directors of stability in Barcelona and Ancona respectively, explain why clients from all over Europe choose to perform their stability tests with them:

“We at Kymos say we commit to our clients – this is not just a phrase but a lived reality” begins Dr. Valdes. “Clients appreciate our experience with a huge variety of drug products and substances. We store tablets and liquid formulations for pharmaceutical and biotech companies as well as creams for the cosmetic industry and perform all sort of studies. Based on our extensive experience in in stability studies and analytical method transfer: We can adapt our protocols to our client’s requirements and offer expert advice before the start of the actual project.” 

Francesco Spadoni supports Damarih’s words: “Not only do we perform standard ICH and ongoing stabilities but also in-use, holding times, freeze and thaw, transportation, as well as photostabilities and stress testing under different conditions. And our commitment to the client doesn’t end there: Having test chambers for all climatic conditions in two different sites, one being the backup of the other, allows us to offer increased operational reliability.” Dr. Valdes joins in: “Due to our Laboratory Information Management System (LIMS) all of our activities are tracked and the Spanish and the Italian sites can collaborate perfectly. Even the GMP authorities were impressed by the proficiency of our LIMS system”.

But according to both directors these are not the only reasons why customers like to work with Kymos. Francesco begins: “Our clients appreciate our dedication to their projects. Our whole team is committed to a strict compliance with deadlines, regular communications and immediate availability for discussion. Tailored services like MS characterization of unknown related substances that may appear during an ongoing study are an example of our will to please our customers.” Damarih continues: “We have accompanied some of our clients for over a decade. Long-standing intensive relationships give our sponsors confidence and certainty but also give us great motivation as they are proof of our good work.” 

Dr. Dino Mangion, Head of Malta Operations at Medichem/Combino Pharm Ltd and one of Kymos’ key recurring customers, has a few words regarding his experience working with the stabilities department: “Combino Pharm experienced a big surge in work in recent years” Dr Mangion states, “and consequently we decided that it would be necessary to outsource the stability studies of some big projects. Of course, we wanted to make sure that our stability studies would be in the best hands, and that’s when we met Kymos! We were positively impressed when Kymos reacted to our needs by investing in their stability capabilities, and now, two years down the line, with projects in full-swing, I can safely say that we made the right choice. In Kymos we have found a reliable, committed, trustworthy and professional partner.” 

Indeed, Damarih Valdes, Francesco Spadoni and their teams take pride in their satisfied customers and a job well done. Given the growing complexity of stability programmes in an increasingly globalized world, they both anticipate the need for outsourcing will continue to grow among firms like Medichem/Combino Pharm which supply to multiple countries and need to test storage conditions for different regions. And both Barcelona and Ancona sites will be ready to meet the challenge. 

KYMOS and its Italian subsidiary PHARMAPROGRESS is an EMA and FDA-inspected European contract laboratory organization offering GMP-certified expert stability studies. Here you can view more information about KYMOS’ Stability Studies, Method Development and Validation and Quality Control or contact us on info@kymos.com.

COMBINO PHARM (Malta) Ltd. is part of the MEDICHEM group, a Spanish pharmaceutical organization which develops and manufactures APIs and finished dosage forms. Combino Pharm (Malta) Ltd. specialises in the development and manufacture of solid oral medicinal products. It has a vibrant portfolio of internally developed products which are available for out-licensing and also does contract manufacturing work for top international clients.  It manufactures products for worldwide markets, including the US. Click here to learn more about MEDICHEM.
 

Click here to learn more about our Stability Services, our Batch Test and Release Services and about our Method Development and Validation Services or contact us on info@kymos.com

 

 

Add new comment