Our carefully selected portfolio of industrial scale products have a proven track record of successful applications and use in scale-up projects. We can support the discovery, development and manufacturing of customer pharmaceutical and biotechnology products, from pre-clinical, phase I, II and III to small scale commercial operations.
Biotage metal scavengers are a more effective alternative to traditional carbon batch adsorption processes. They have the lowest metals content, and also excellent extractable profiles, therefore not likely to risk contamination, unlike competitive materials we tested. Furthermore, Biotage metal scavengers offer volumetrically, a much more compact solution than carbon, requiring 48 times less volume for the same degree of Pd removal in our studies.
This study was conducted in 3 parts. Metal scavengers were investigated for inherent metals content by ICP analysis methods. Additionally these scavengers were extracted in a range of common solvents in order to show extractable/leachable levels. We demonstrate an example metal scavenging mitigation step, looking at the corresponding API mass yield, purity and also metals data.
Utilization of synthetic chemistry routes developed in late lead optimization is becoming more widespread as the desire to efficiently confirm pre-clinical compounds has increased. In some cases, chemical processes use reagents which are specific and cannot be substituted on scale up. Such reagents include transition metal catalysts.