Competence   
API Production   

Our expert team has more than 15 years experience in process development, production, QC, QA, and regulatory affairs of biotechnology-derived APIs (active pharmaceutical ingredients). Our management team was formerly responsible at big pharmaceutical companies for registration of over 20 APIs for clinical studies, product-transfers (various locations and partners) and market supply. Our competence covers novel biopharmaceutical and biogeneric APIs from clinical material to market supply. Examples of previous projects are listed below.        Product/API  Countries  Stages of Product  EPO  World-wide  Market supply  various MABs  World-wide  Market supply  various PABs  EU  Market supply  PA  World-wide  Market supply  G-CSF  EU  Clinical phase  Interferons  World-wide   Market supply   Adenosine Deaminase  US  Market supply  Insulin  World-wide  Clinical phase  Parathormon   World-wide  Clinical phase             Abbreviations:  EPO  Erythropoietin  PA  Plasminogen activator  G-CSF  Granulocyte colony stimulating factor  PAB  Polyclonal antibody  MAB  Monoclonal antibody