Clinical and commercial manufacturing
Concept Life Sciences delivers reliable, cost effective and timely supply of intermediates and APIs. Our technical and quality expertise makes us a leading strategic manufacturing partner.
Concept can produce 1 to 10kg batches of API to GMP standards from our API manufacturing suite, located at our research and development facility.
By working side by side with PR&D chemists we ensure knowledge retention and a smooth transition throughout the product life cycle which enables timely delivery.
Our clinical manufacturing team is experienced in rapid process development, IND enabling support, process scale-up and manufacture of chemical entities for toxicology studies and clinical trials.
Comprehensive, end-to-end service
Concept’s network of facilities is fully connected, enabling us to provide a comprehensive, end-to-end service. We have expertise in process validation, cleaning validation, analytical method development and quality risk assessment studies, product sourcing of supply chain for raw materials, regulatory starting materials and intermediates, culminating in API batch release.
Our manufacturing capability includes flow chemistry, the handling of high and low temperature reactions and high-pressure hydrogenations. Our API manufacturing suite houses several vessels ranging from 20 to 120 litres with associated filter and drying equipment and the ability to handle HPAPIs using containment technologies.
We provide full supporting documentation including synthesis reports, manufacturing record sheets, batch records analytical methods and cleaning records.
Bioanalysis and biomarkers
Cleaning validation and verification
Contaminants and foreign bodies
GXP analytical method development, validation and transfer
Out of specification investigations
Process research and development and pre-clinical API manufacture
QC release and GMP release testing
Storage stability studies