Contact Us
ANALYTICAL · FEATURED

Signature ServicesFeatured Services

Leveraging two distinctive platforms - AUC analytical ultracentrifugation and Stunner microfluidic multi-function analysis - Zencore provides label-free, ultra-low-sample-volume, high-precision biologics analysis services.

Back to Analytical Services
Analytical Ultracentrifugation

AUC analytical ultracentrifugationAUC

Zencore has officially launched AUC technical services, making this the first analytical ultracentrifuge in China's biopharmaceutical industry dedicated to providing technical services. The AUC team's chief scientist has years of experience as an AUC technical lead at leading international pharmaceutical companies.

Q1　What is analytical ultracentrifugation (AUC)?

AUC is an analytical ultracentrifuge equipped with an optical detection system that tracks solute migration during centrifugation. Under centrifugal force, solute moves in the direction of that force, forming a solvent/solute boundary whose shape and migration rate depend on the solute's molecular weight, shape and self-association behavior, as well as solvent density and viscosity. By recording changes in the boundary (absorbance or interference optics), the optical system can determine protein molecular weight, sedimentation coefficient and the content of monomers, aggregates and fragments - this is velocity sedimentation. When centrifugal force and diffusion reach equilibrium to form a stable boundary, analysis of the boundary profile also yields molecular weight, diffusion coefficient and reversible self-association characteristics - this is equilibrium sedimentation.

AUC analytical ultracentrifugation

Q2　How is AUC applied in biologics analysis?

  • Determining protein molecular weight, sedimentation coefficient, etc.;
  • Determining the content of monomers, aggregates and fragments of the drug protein in samples;
  • Assessing the reliability of size exclusion chromatography (SEC) methods and supporting SEC method establishment;
  • Studying the reversible self-association of drug proteins in different solution formulations, assessing its impact on stability and flagging the immunogenicity risk that higher-order aggregates may pose (dimers and higher-order aggregates can be detected);
  • Studying protein-protein and protein-small molecule interactions.

Q3　What advantages does AUC offer over other protein analysis methods?

Compared with SDS-PAGE and mass spectrometry, AUC analyzes drug proteins in their native state without disrupting native conformation, requires neither labels nor standards, and allows samples to be recovered and reused. Compared with SEC, AUC is performed in solution and requires no stationary-phase medium, avoiding molecular weight estimation bias caused by protein-medium interactions and the over- or underestimation of aggregate/fragment content. The FDA therefore recommends that SEC results at the BLA filing stage be supported by an orthogonal method - and AUC is the ideal choice.

Q4　What analytical services can Zencore's AUC provide?

Zencore's AUC system is equipped with both UV and interference detectors, and its temperature control system maintains analysis temperatures stably between 4 C and 40 C, with up to 7 samples analyzed simultaneously. The following technical services are available:

  • Analyzing monomer, aggregate and protein fragment content for Drug Substance / Drug Product proteins;
  • Determining protein molecular weight in the native state;
  • Comparing AUC and SEC results to support SEC method establishment;
  • Measuring and characterizing the reversible self-association of drug proteins in different buffers, providing the basis for formulation buffer development.
AUC analytical ultracentrifugation
Microfluidics & Developability

Stunner microfluidic multi-function analysis platformStunner

Stunner integrates three detection modules - UV/Vis, DLS and SLS - and uses microfluidic chip technology: a single measurement requires only 2 uL of sample to obtain concentration, particle size, polydispersity and aggregation data. It is widely used across biopharmaceutical fields including AAV, antibodies, ADCs and mRNA.

High-precision multi-channel analysis of multiple samples

Uses 96-channel microfluidic plates to avoid sample cross-contamination and operator-induced measurement error, obtaining concentration, particle size, polydispersity and aggregation data in a single measurement.

Figure 1: 96-channel detection plate - full-spectrum UV/Vis/DLS/SLS analysis with only 2 uL of sample
Figure 1: 96-channel detection plate - full-spectrum UV/Vis/DLS/SLS analysis with only 2 uL of sample

Developability assessment with minimal sample

Samples are scarce during early screening, and Stunner requires only 2 uL per measurement, so developability assessment can be completed with minimal sample, saving time and cost. With a dynamic range of 0.03-275 mg/mL, developability assessment of high-concentration formulations is equally straightforward.

Figure 2: A single sample measurement yields the data needed for formulation developability assessment
Figure 2: A single sample measurement yields the data needed for formulation developability assessment

Rapid formulation screening

While measuring DLS, Stunner also provides real-time, precise protein concentration, readily yielding the diffusion interaction parameter (kD) and second virial coefficient (B22) to predict the aggregation propensity and long-term stability of antibodies/ADCs and other proteins in buffer. With minimal sample consumption and fast measurement, it enables rapid, low-cost identification of optimal formulations.

Figure 3: Data processing functions intuitively reflect changes during formulation storage, making formulation screening clear at a glance
Figure 3: Data processing functions intuitively reflect changes during formulation storage, making formulation screening clear at a glance

Rapid ADC DAR determination

The Unmix algorithm deconvolutes absorption curves to quantify antibody and conjugated drug separately, enabling rapid determination of DAR values for ADC samples. This supports rapid screening and reaction monitoring in early ADC research, accelerating ADC development.

Figure 4: Rapid determination of ADC DAR values using Stunner
Figure 4: Rapid determination of ADC DAR values using Stunner

Compliance

Stunner verifies instrument performance using independently certified NIST standards, meeting USP and Ph. Eur. requirements for UV/Vis quantitative instruments in terms of absorbance, accuracy, precision, linearity, wavelength accuracy, stray light and resolution. The software complies with 21 CFR Part 11, with full data traceability.

Signature analytical services — inquiries welcome

AUC analytical ultracentrifugation · Stunner microfluidic multi-function analysis platform.

Inquire now