Finding creative means to help our clients achieve their goals
First in human cell line-derived medicinal products
In 1996, the first MAA filed by Triskel through the EU centralised procedure was for a fully human mAb produced by Epstein-Barr virus-transformed human B-lymphocyte cells. This mAb also represented the first ever human cell line-derived medicinal product to be approved in the EU.
First in biosimilars
First in cell therapy medicinal products
First in transgenic plant-derived active substances
In the absence of an appropriate scientific and regulatory framework for the development of transgenic plant-derived biological medicinal products, and in the context of a project for such a product, Triskel collaborated with the EMA's Biotech Working Party to develop specific scientific guidance. This collaboration resulted in the publication in 2006 of the "Guideline on the quality of biological active substances produced by stable transgene expression in higher plants".
Unique Learning/Confirming approach
- Learning: Very early in development of the molecule, we integrate pharmacokinetic/pharmacodynamic and population modeling methods to thoroughly and efficiently identify the dose response relationships and their source of variability both for efficacy and for safety. Thus, we can establish activity, indications, target population, efficacy and dosage parameters quickly and efficiently.
- Confirming: Having obtained hard data on the product, we can design efficient Phase III studies needed to demonstrate positive benefit /risk ratios and to convincingly support product claims and regulatory approval.