Physical quality

Applies to reconstituted peptide solutions intended for parenteral administration, and to the assessment of whether a lyophilised cake reconstitutes to a solution free of visible and sub-visible particles.

Visual and low-technology assessment of a lyophilised presentation: cake appearance, collapse, shrinkage, colour, reconstitution time, clarity of the reconstituted solution and the presence of visible particulate or fibrillar material.

Applies to peptides and proteins prone to self-association, and mandatorily to the amylin analogue class, to Fc-fusion and antibody-conjugate products, and to cationic amphipathic peptides. Reverse-phase purity does not detect aggregates…