Clinical API
manufacture

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.

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Concept Life Sciences offers GMP pharmaceutical stability studies and ICH storage services to support development, commercial stability studies and sample batch release. Concept’s stability team designs and delivers GMP stability programs for a comprehensive range of dosage forms, APIs and product types.

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