Dear forum members,

I would like gain some inishgt on blinded packaging for an anti-body IMP.

The IMP and placebo are solutions for injections and will be filled in vials and administered to patients by SC or IV injection. Since the two have slightly different viscosity and color, the manufacturing team is wondering how we can best conceal these differentiators. There was also a concern that amber glass vials are not suitable for protein-based IMP since they are colored with iron oxide that will trigger Fe eluates. We are also considering the use of opaque labels, but the different colors between the solutions may be identifiable from the bottom of the vial.

It would be much appreciated if someone could share experiences with blinded packaging for similar drugs. I am also interested to know if there are other types of amber vials or syringes / primary and secondary packaging solutions that are suitable for blinding these types of drugs.

Thank you in advance for your time and support.