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In-use stability testing for multidose products was initially based in the Note for Guidance on In-use Stability Testing of Human Medicinal Products of the CPMP of the EMA, in March 2001. According to it the purpose of in-use stability testing is to establish a period of time during which a multidose product can be used whilst retaining quality within an accepted specification once the container is opened.

In line with the Ph. Eur. implementation strategy for the ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) has been deleted and a new section is included: “If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk (1.3 µS/cm), a risk assessment according to general chapter 5.20 Elemental impurities is carried out.

On September 2018, FDA revised the status of Topical Generic Products and their future perspectives in a two-day Conference on Complex Generic Drug Product Development Workshop.

KYMOS has moved its offices to a second building (nº5) in the Valles Technological Park. These new facilities will allow us to continue expanding our company in the next years without space limitations. The company has invested around half mllion euros in remodelling 1,000m2. The building includes training room, meeting rooms, archive, cafeteria and offices for Finance, Quality Assurance, IT, General Services and Management.

Heparin is a sulfated glycosaminoglycan present as a mixture of heterogeneous molecules varying in molecular weighs used in medicine as anticoagulant. It is present in mammalian tissues and is usually obtained from the intestinal mucosa or other suitable tissues of domestic mammals for food by man. It is purified to retain a combination of activities against different fractions of the blood clotting sequence.

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.