Blog

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 as heparins; immunoglobulins; insulines; and innovative antibody drug conjugates.

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, iv) reporting of serious undesirable effects.

Over the past 25 years the criteria required for bioanalytical methods has evolved significantly. The harmonization of bioanalytical methods requirements started in 1990 during the AAPS and FDA Crystal City Meetings. In 2000 the Crystal City II Meeting laid the foundations of the 2001 FDA Guidance on Bioanalytical Method Validation.

On December 19, the Mayor of Camerata Picena Mr. Paolo Tittarelli, inagurated the refurbished facilities of Pharmaprogress in Ancona (Italy). An important investment plan has been executed after the Pharmaprogress acquisition by Kymos in November 2016. The refurbishement has been focused in electric supply lines, power generator, data center, LAN and laboratory benches. In addition, during this first year new HPLCs, balances, and other instruments have been acquired. The visit of the Mayor finished with a Christmas cellebration with employees and partners.

Kymos presented an oral communication on the immunogenicity of gonadotrophines used for ovarian stimulation, during the 10th EBF Open Symposium held past 15-17 November 2017 in Barcelona. Kymos' Immunology Manager, Dr. Carles Morte, shared with the attendees the bioanalytical strategy followed and the results of two clinical studies. This work was done in collaboration with IBSA (Switzerland), the University of Basel (Switzerland), the Semmelweis University (Budapest, Hungary) and the Institut Universitari Dexeus (Barcelona, Spain).

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.

KYMOS and its Italian affiliate PHARMAPROGRESS have particIpated in the Worldwide CPhI 2017 in Frankfurt during October 24-26. The stand was very attended and we had around 80 meeting with current and potencial partners. We thank all our visitors for their interest and friendliness.