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.
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.
