Formulation: High concentration formulations survey

High concentration formulations can be challenging to develop and there was interest in the Formulations workstream in the comparative approaches taken towards

  • Stability testing
  • Syringability testing
  • The approach to subvisible particles,
  • How solubility, aggregation, and particle formation issues are studied
  • The challenges associated with high viscosity formulations in PFS,
  • The use of needle-free delivery systems or large volume injectors
  • Concentration-driven formulation challenges
  • The approach to unstable biopharmaceuticals
  • How acceptable opalescence is defined
  • How Gibbs-Donnan and excluded volume effects for excipients are accounted for, among other more detailed questions.

In total the survey includes the responses from 16 member companies

This document is reserved for the use of BioPhorum members only.

I don't have access to this document

Make a selection below and submit your request. We will get back to you ASAP.

My company would like to become a member

If you're not sure if your company is a member of this Phorum, or if you would like to enquire on behalf of your company about becoming a member, please see our membership page.