Compatibility Evaluation for Container Closure System(CCS)

Stability Testing

Biopharmaceuticals are subjected to various stresses during manufacturing, transportation, storage, and administration. It is essential to evaluate the stability of the product in its container. We use a variety of methods to evaluate the impact of various stresses on the drug product in its container.

Quanifitation of Protein Aggregates

The size of aggregates of biopharmaceuticals ranges from tens of nanometers to hundreds of micrometers. We analyze the concentration and size distribution of aggregates using a variety of analytical techniques.

Characterization for Protein Aggregates

LC-MS, native MS, and SDS-PAGE are used to analyze aggregate components.

Structure Analysis

Post-translational modifications such as oxidation, disulfide, and deamidation are evaluated by peptide mapping using LC-MS/MS.

Quantification of Protein Adsorption on the Surface of Containers

The amount of protein adsorbed on the surface of vials and syringes is quantified using the ultra performance LC (UPLC) and micro BCA methods.

Immunogenicity Assessment

Protein aggregates and silicone oil droplets are considered a potential source of immunogenicity. By monitoring the secretion of innate immune system cytokines from human peripheral blood mononuclear cells, we can evaluate the evoked immune response.

Insoluble Particle Analysis

Micron-sized aggregates can be analyzed by flow imaging analysis. FlowCam provides information on the size, number, and shape of particles by continuously capturing high-resolution images of particles in a liquid as they pass through a glass flow cell.

Example of measurement of micron particles in antibody drugs

Quantification of Silicone Oil Droplets

Some pharmaceuticals filled in pre-filled syringes may contain silicone oil droplets. Images obtained by FlowCam can be classified into protein aggregates and silicone oil droplets using convolutional neural networks (CNN).