CPhI Worldwide 2019 takes place 5th - 7th November and @Kymos is sending its largest ever contingent of #experts to repeat last year's success. Covering every step of the supply chain, CPhI is the perfect place to network and Kymos is an ideal multidisciplinary partner to outsource your pharmaceutical needs.
KYMOS is proud to announce that Dr Carles Celma, our Scientific Director, will be speaking at the Biosimilars and Biologics Congress in Rome on October 17-19.
Kymos complies with FDA & EMA inspections as well as GLP, GMP and GCP standards. In particular, as a GMP certified CRO, we take the responsibility tosupply manufacturer authorisation for quality control purposes. In this guide, Kymos helps outline the current situation of Brexit and what this means for batch testing and batch release after Brexit.
The development and validation of a process specific assay for host cell proteins (HCP) determination in therapeutic recombinant proteins should follow the specifications contained in monograph 2.6.34 of the European Pharmacopeia in a step by step approach:
1. Production of the HCP antigens
On October 18, 2018 the EMA published the Draft Guideline on Quality and Equivalence of Topical Products. On June 30, 2019, the period of Consultation will end and it is expected to be in force by the end of the year. The guideline clearly states that regulatory applications based in literature to demonstrate safety and efficacy should be supported by equivalence data of the formulation.
Electrophoresis is an analytical technique widely used for purity determination and identification of therapeutic proteins. This technique is based in the migration of the proteins under an electrical field according their electrophoretic mobility. Depending of the type of the electrophoresis, different quality attributes of the protein can be measured. Sensitivity, robustness and throughput will depend of the format used, being the classical flat/vertical gel formats displaced by the newest capillary formats due to their inherent advantages.
Joan Puig de Dou, CEO of Kymos Pharma, a Spanish analytical CRO, shares his insights in the changing dynamics of the industry and explains how remaining independent in the face of industry consolidation is a strategic priority to leverage both quality and specialization for the company’s clients.
The interview has been published online in Pharma Boardroom:
https://pharmaboardroom.com/interviews/joan-puig-de-dou-ceo-kymos-pharma-spain/
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.
