Physical Property Characterization

In addition to key quality parameters such as purity, impurities, stability, etc., there are also parameters such as pH, osmolality, appearance, concentration, etc., which are used to characterize the general quality attributes of antibody drugs. Creative Proteomics refers to the standard methods given by the pharmacopoeia to carry out a detailed characterization of the above quality attributes of the antibody drugs in order to ensure the quality of the drugs.

Our Physical Property Testing Services of Antibody Drugs

Creative Proteomics offers comprehensive testing services for antibody drugs, including pH, osmolality, appearance, and concentration testing. Here are the details of each of these services:

• pH Testing

pH testing is performed to measure the acidity or alkalinity of the antibody drugs. The pH value indicates the stability and compatibility of the drug, as well as its potential for degradation or aggregation. Our highly trained and experienced team uses precise measurement techniques to determine the pH value accurately.

• Osmolality Testing

Osmolality refers to the concentration of osmotically active particles in a solution, typically measured in milliosmoles per kilogram (mOsm/kg). We offer osmolality testing to assess the concentration of solutes in your antibody drug formulation. This testing helps in determining the isotonicity of the drug, as well as its suitability for injection or infusion.

• Appearance Testing

Appearance testing is conducted to evaluate the visual characteristics of the antibody drug formulation. Our experts assess factors such as color, clarity, particulate matter, and any signs of physical instability. Testing the appearance of the drug ensures that it meets the desired visual standards and does not contain any visible impurities.

• Concentration Testing

Concentration testing involves determining the exact amount of the antibody drug present in a given sample. Concentration testing is crucial for ensuring the potency and efficacy of the drug, as well as maintaining consistent dosing. Our advanced analytical techniques, such as UV-Vis spectrophotometry or HPLC, provide accurate results.

In addition to these individual tests, our company also offers comprehensive analytical packages that include all of these services. These packages are designed to meet regulatory requirements and ensure the quality, safety, and efficacy of your antibody drugs.

Physical Property Testing Methods at Creative Proteomics

Our testing services are carried out in state-of-the-art laboratories by highly skilled scientists and technicians. Our team of highly skilled scientists and technicians use a range of advanced technologies to ensure that antibody drugs meet the necessary quality standards.

Creative Proteomics is proud to offer a comprehensive antibody drug testing service. Our physical property testing services of antibody drugs is dedicated to providing pharmaceutical companies, research organizations, and other stakeholders with accurate and reliable assessment of their antibody drugs. For more information or to request our services, please feel free to contact us.