Fast into man.....with no compromise on quality

Transferring successful concept formulations and processes from the preclinical development stages to clinical Phase I and II production is an extremely challenging and demanding task. Therefore, an expert understanding of both cGMP manufacturing and regulatory principles is paramount to ensure a seamless and trouble free process.

To offer further integrated services to our clients, Synectix has extended it's activities to provide additional services in the development chain in the form of GMP clinical trial supply manufacture.

Our scientists are experienced in technology transfer for cGMP manufacture of oral, parenteral and pulmonary dosage forms, having successfully developed numerous formulations for both Phase I and II clinical trials supply. Working with a dedicated project manager and our in-house EU Qualified Person (QP), Dr Ken Caldicott , we can manage all stages of the project on behalf of the client, ensuring that special attention is paid to maintaining cGMP standards during the entire process. Careful coordination with the client and manufacturing site ensures flawless execution of the clinical supply planning.

The following activities will be undertaken:

• Transfer analytical methods
• Source raw materials
• Clinical trial manufacture for phase I and II
• Process validation
• Cleaning validation
• Test batches to provisional specifications

Our capabilities include:

• High potency / cytotoxics
• Sterile products (aseptic, freeze-dried, sterilised)
• Tablets/capsules (immediate, modified and sustained release and film coated)
• Liquid filled hard gelatin capsules (oral liquids and suspensions)
• ICH Stability testing
• Analytical services

Our specialised formulation technologies include:

• Spray drying (aqueous and organic solvents)
• Freeze-drying
• Nano-miling (cGMP production available Q3 2009)