Leachables study by LC/MS/MS and GC-MS

Investigation of interactions between product matrix and primary packaging/contact materials/devices

Therapeutic Modalities:

Biologics, Cell & Gene Therapies, Small Molecules

Development Phases:

Research, Preclinical, Early-phase Clinical, Late-Phase Clinical, Commercial

Quality Standard:

GMP and non-GMP (ISO 9001:2015)

Pharmacopoeia:

PQRI, BPOG, EMEA, USP, FDA guidelines