Strategic partners, Crystal Bio and CATUG, combined efforts to evaluate the effects of mRNA-LNP integrity during international shipping to compare data between shipping sites for: 

ꔷ Size with distribution 

ꔷ Encapsulation 

ꔷ Purity

Following the successful launch of CQAs in LNP-mRNA Modality, we continue the series with CQA in ADC Modality. This white paper discusses: ADC components, ADC-related CQA, Impact on safety and efficacy.

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.