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KYMOS presented an oral contribution at Waters Farma Forum held past 14 June 2018 in Barcelona. Kymos' Biologics Scientific Director, Dr. Carles Celma, shared with the attendees some studies related to the characterization of recombinant proteins. In the talk was discussed about the application of the liquid chromatography coupled to the high resolution tandem mass spectrometry (LC-HR-MS/MS) to the characterization of the primary structure of recombinant proteins.

KYMOS presented an oral communication at Labware 2018 EU Customer Education Conference held past 4-8 June 2018 in Sitges, Barcelona. Kymos' Scientific Director, Dr. Jaume Pascual, shared with the attendees the LIMS project that the company implemented. Dr. Pascual, together with Labware consultant Mr. Pere Palou, explained this challanging project consisting in the integration of different modules: contract lab, stability and pharma.

The FDA has issued a Guidance for Industry entitled “Bioanalytical Method Validation”. This guidance replaces the draft guidance that was issued in September 2013, and reflects advances in science and technology validating bioanalytical methods. 

Vaccines are biological products intended to deliver antigens with the scope to induce an immune response and immune memory against a particular disease. Vaccines can be prophylactic or therapeutic and generate immunity by humoral or cellular response.

Revised USP and Eur. Phar. heparin monographs were implemented after significant side effects emerged in 2008 after the administration of intravenous heparin that caused over 200 deaths in United States and Germany. The origin of this problem was attributed to contamination with oversulfated chondroitin sulfate (OSCS) on heparin raw material manufactured in China.

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.