Antibody drug conjugates (ADC) are typically composed of an antibody chemically attached with small molecule drugs as payload through linkers. D0 refers to an antibody conjugated with no drug (0 payload or naked antibody).

With an ever-increasing interest in designing mRNA-based vaccines, mRNA-Lipid nanoparticles (mRNA-LNP) formulation is a relatively new modality. This white paper series first discusses numerous quality attributes with influencing potency, stability, toxicity, and risk assessment relevant to mRNA-LNP modality.

In the biomanufacturing industry, Critical Quality Attributes (CQA) are essential standards that must be met before biopharmaceuticals or medical devices can be released for patient use. As a fundamental component of CQA for a Drug Product (DP), manufacturers are required to conduct rigorous testing to ensure compliance with regulatory limits for adventitious agents.