ELISA (impurity)

Quantification of impurity (e.g. process related impurity (insulin, HCP, rPA) or cleaning validation)

Therapeutic Modalities:

Biologics, Cell & Gene Therapies

Development Phases:

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

Quality Standard:

GMP and non-GMP (ISO 9001:2015)