Nano-laser particle size analyzer in testing of biological drug aggregates

  The aggregation phenomenon of biological drug monomers is quite common. For example, the special physical characteristics of individual proteins may lead to the aggregation of biological drug monomers, the oscillation and external pollution in the process of transportation or storage, and even some factors in the process of drug use may also lead to the aggregation of drug monomers .As the drug aggregates grow larger, their effectiveness decreases and dangerous side effects may occur, such as shock caused by the body's immune response, or even death. Therefore, it is extremely important for biopharmaceutical manufacturers to inhibit the formation of harmful aggregates and timely detect the particle size range and concentration of aggregates. In the process of biopharmaceutical production, drug aggregation inhibition, drug storage method development and quality control all need to detect drug aggregates.

  According to particle size, biological drug aggregates can be divided into three categories: less than 100 nm, 100 nm ~ 10 μm, and more than 10 μm. The measurement of particle concentration in the range of 100 nm to 10 μm is the most concerned. At each stage of biopharmaceutical production and development, aggregates within this range need to be evaluated. The concentrations of these three types of aggregates are commonly measured by volumetric rejection chromatography (SEC) for samples less than 100 nm; Liquid particle counters were used for samples larger than 10 μm. Particle in the range of 100 nm to 10 μm are called subvisible particles (SVP). At present, there are few effective methods for measuring SVP aggregate concentration in the market,and nano-laser particle size method is one of them. It can not only measure the size range of nano-sized particle samples, but also test and monitor the concentration of drug monomer aggregates in biological drugs, so as to evaluate the drug efficacy, safety performance and other aspects.