Quality Characterization Analytical Services
From Innovation Lab
Macromolecules play an integral role in therapeutic research and development, encompassing therapeutic drugs such as monoclonal antibodies, recombinant proteins, polypeptides, antibody-drug conjugates (ADCs), and bispecific antibodies. Unlike small molecule drugs that are less than 1kDa, macromolecules have a significantly higher molecular weight in the 10-1000kDa range. Due to this size, there are numerous potential modification sites and can easily aggregate in solution to form particles. Thus, quality characterization in different stages throughout the drug life cycle and production process is critical in ensuring the success of drug research and development and accelerate the drug development timeline.
Servcies Overview
Several key elements of macromolecular drug characterization include accurate amino acid sequencing, molecular weight determination, stability, and degree of polymerization. Of these characteristics, stability is one of the main indicators for evaluating the quality of pharmaceutical preparations and is the main basis for determining the service life of pharmaceutical preparations.
ACROBiosystems has built a quality characterization and analysis service platform based on SEC-MALS and UNcle. Our platform enables the analysis of melting temperature (Tm) and aggregation temperature (Tagg), particle size, molecular weight, degree of polymerization, and purity. Both instruments have low sample consumption, high sample throughputs, and are label-free testing methods. With our available technologies, our platform meets the testing needs of the entire drug research and development, process and process development, product quality control and others.
Instrument Platforms
Principle of SEC-MALS
Size-exclusion Chromatography (SEC) is a chromatographic method that separates components by its molecular size. Uniformly porous beads are packed into a chromatographic column to separate a sample based on molecular size, and the protein purity is obtained according to the separation spectrum. Each component separated by SEC enters the multi-angle light scattering (MALS), and light scattering occurs when the laser illuminates each group. MALS is a post-column detection method that measures the intensity of scattered light at multiple angles at the same time, and the intensity is proportional to the square of molar mass, concentration and refractive index increment. Through the combination of SEC-MALS, the molecular weight of an analyte can be directly calculated and the aggregation form of protein can be judged.
Sample Type
- Recombinant Proteins
- Antibodies
- Polypeptides (Column and method shall be provided)
Principle of UNcle
UNcle is a technology platform that tracks the folding state of protein by detecting the changes in its endogenous fluorescence through full-wavelength fluorescence. This determines the Tm of the protein stability and reflects the thermal stability or chemical stability of the protein. Using Static light scattering (SLS) , the stability of protein aggregation can be calculated. During the process of protein denaturation, its conformation gradually opens and hydrophobic points are gradually exposed, and when a certain level (temperature) is reached, the protein molecules begin to aggregate, leading to an increase in scattered light signal, which determines the initial Tagg of the protein. Using dynamic light scattering (DLS), the particle size and its distribution can be calculated through the fluctuation and the correlation function of light intensity.
Sample Type
- Tm&Tagg determination: Recombinant Proteins, Monoclonal Antibodies, Bispecific Antibodies, Antibody-Drug Conjugate (ADC), Adeno-Associated Virus (AAV), Lipid Nanoparticle (LNP)
- Particle size determination:Unlimited
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