GlycoSyn follows stringent protocols to ensure the protection of client intellectual property.
The following steps outline the typical stages of client interaction from initial contact through to delivery of cGMP grade material for use in human clinical trials:
1. Contact us
2. Confidentiality agreement
- We provide a two-way confidentiality agreement to the client which outlines our obligations to protect from disclosure any information received.
3. Client’s structure, synthesis and development information exchanged
- We ask the client for a comprehensive dossier detailing the full extent of the structure and synthesis pathways of the compound for evaluation by our Process Development division.
- Typically, this requires the client to provide the current scale of synthesis, process descriptions, analytical methods, reagents and solvents required to synthesise the compound.
- The client will also be asked to detail the next steps in their development program so that we can design a suitable Chemical Manufacturing and Control regime to meet current and future product and regulatory needs.
4. Synthesis and scale assessment
- We undertake a comprehensive assessment of the information provided by the client - detailing any investment that may be required in process development, route optimisation and scale manufacture prior to entering the cGMP Manufacturing stage
- The client will receive a detailed milestone-based proposal explaining the investment and technical stages of Process Development and Optimisation required to meet their needs.
- The client will also receive an estimate of the future cGMP manufacturing costs for their compound, a very useful document for planning and budgeting purposes.
5. Contracting our Services - Process Development and Optimisation
- We supply the client with a Professional Services Agreement which details technical and financial milestones for the Process Development and Optimisation stages of manufacturing. GlycoSyn provides these services to clients on a daily time and materials basis. Expenditure is tracked against your agreed milestones with progress reported at requested intervals.
- As this stage of development presents a series of significant risks that may impact on future manufacturing and clinical programs, the client may halt the Process Development program at any stage, paying only for services performed.
- During this stage of Process Development and Optimisation, we typically perform services for the client which include route optimisation, lab-scale process synthesis, analytical method development, product specification determination and scale-up validation from gram to kilo scale.
6. Contracting our Services - Process Development non-cGMP Manufacture
- We provide the client with a Professional Services agreement which details the product specification and desired quantity of material to be manufactured. GlycoSyn provides these services either by fixed quotation or daily time and materials basis depending on synthesis required.
- GlycoSyn provides non-cGMP gram to kilo-scale manufacture of compounds for clients that require material for stability, toxicology, pre-clinical and non-human clinical studies.
- GlycoSyn clients are required to undertake this stage of development prior to entering the cGMP manufacturing stage.
7. Contracting our Services - cGMP Manufacture
- We provide the client with a comprehensive Quality Agreement and Contract for Manufacture which details all components of the cGMP manufacture of the client compound. GlycoSyn provides fixed price, guaranteed quality compliance and date of delivery contracts to meet the stringent international requirements of cGMP manufacture by synthesis of compounds for human clinical trials.
- At the completion of this stage, clients complete their contract with GlycoSyn having received high-quality cGMP grade material suitable for clinical trials, validated analytical methods, final product specification, full batch production records and 100% retention of all intellectual property generated during the course of any stage engagement with GlycoSyn.