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07Oct21

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 had been part of before. Dr. Latorre remembers her beginnings at Kymos:

“I started working in various groups but as method development and validation activities became more and more prominent, the department I currently lead came to be. Clients turned to us for their validations or when they needed support optimising and upscaling existing methods. Our department acted as the entry gate for many different projects.”

Dr. Latorre explains how this is the key to her team’s capacity to deal with not everyday requests:

“Having worked with so many different projects in the past we have the knowledge and the flexibility to guide our clients through the development of very challenging projects. To put things in perspective, an average pharmaceutical lab would normally manage up to 4 launches per year, involving 12 new developments and validations, while in contrast our department processes around 72 validations annually, thus accumulating a wealth of new experience year after year.” Dr. Latorre continues: “On top of that, being part of a multinational group allows us to coordinate with our peers at our Italian subsidiary Pharmaprogress, Dr. Francesco Spandoni’s team, who in turn have a different knowledge base and complementary instruments. Together we develop robust methods that accompany our customers through the entire life cycle of their products.”

In fact, Dr. Rosa Latorre’s team acts as a central hub for many other departments in Kymos, delivering tailor-made methods for Quality Control,  Batch Testing and Stability assays.

“We are always willing to help.” Dr. Latorre continues. “Sometimes our clients need guidance with specifications and requests from the authorities, or developing analytical methods for drug products, related substances as well as elemental or genotoxic impurities to name a few. In the recent past we noticed an increasing need to determine residual solvents in topical products and we quickly purchased several enhanced cell systems to perform dissolution tests for semisolid drug products. Now we have this market need covered and I think it is a good example of our predisposition” she concludes.

Method development and validation is a discipline that requires a rare combination of analytical experience and regulatory knowledge. Thanks to excellent professionals like Dr. Rosa Latorre and her colleagues the Kymos group can confidently tackle methods based on EU, US or Asian Pharmacopoeia, proprietary methods or even new developments from scratch. 
 

KYMOS is a GLP/GMP-certified, GCP-compliant, EMA and FDA-inspected European contract research organization specialized in bioanalysis and CMC. Find out more information about Kymos’ services at www.kymos.com or contact us on quotes@kymos.com.

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