Process demonstration

Full analytical (bio)chemistry suite supporting final product, purity, identity and potency characterisation, in process analysis and release testing. Documentation, materials and processes controlled through QMS, ensuring traceability and full regulatory compliance.

Material for pre-clinical, pre-formulation   and stability testing using optimised hosts and individually tailored manufacturing process.

Synthetic chemistry is the default approach for pharmaceutical small molecule manufacturing, able to prepare diverse molecular entities, not found in nature, using well proven methodologies. However, in recent years, small molecule therapeutics have become increasingly complex in design to provide greater potency, efficacy and specificity. This industry trend poses additional challenges for synthetic chemistry to deliver effective manufacturing routes that are atom-efficient, scalable, low-cost and sustainable, particularly where stereo- and/or regio-selective syntheses are necessary. This webinar highlights the opportunity for the exquisite selectivity of enzymatic biotransformations, conducted in vitro or in vivo, to overcome these challenges of tomorrow’s small molecule pharmaceutical manufacturing.