If you have a process development, manufacturing or aseptic filling project you wish to discuss with SynCo, please contact our Business Development department.

Following first contact, we aim to put a 2-way confidentiality agreement in place, enabling us to discuss the full details of the project and for SynCo to provide a pricing estimate or proposal.

A formal Request for Proposal detailing your requirements is always preferred, but if not available, SynCo can provide a list of questions that will enable the program to be discussed in detail. Typical information requested will include:

• A brief background to your company and your strategic objectives for the product in development
• The background to your product in development.:
  • What is the disease target, how will the final product be administered and, which phase of clinical development have you reached?
  • How much material is required for this clinical phase? What is the likely scale of production following commercial launch?
• An overview of what you would like to achieve and an outline of the timescales involved
• Current information regarding the product, such as:
  • process development data
  • formulation data
  • current scale of production
  • current specifications met, including process yields
  • target specifications
  • what analytical methods have already been developed. Are these qualified/ validated?

Following discussions about your exact requirements, we will evaluate whether this project can be completed at SynCo. If so, a formal proposal will be written and submitted to you. This proposal will typically detail any process development experiments that are to be completed, together with assay development, scale-up, process validation, GMP bulk drug substance production and/or aseptic filling. Furthermore timelines and expected costs for the requested project will be presented in a transparent and convenient way.