Sanotac Biolot 100 Antibody Purification-Specific Preparative Liquid Chromatography System
| Brand | Sanotac |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Direct Manufacturer |
| Product Category | Domestic |
| Model | Biolot 100 |
| Application Level | Laboratory-Scale |
| Instrument Type | Medium-to-Low Pressure Preparative LC |
| Flow Rate Range | 0.01–100.00 mL/min |
| Flow Accuracy | ±1% |
| Flow Precision (RSD) | ≤0.5% |
| Maximum Operating Pressure | 20 MPa |
| Wavelength Accuracy | ±1 nm |
| Wavelength Repeatability | 0.2 nm |
| Baseline Noise | ±0.75×10⁻⁵ AU (254 nm, TC = 1 s) |
| Data Acquisition Frequency | 10 Hz |
Overview
The Sanotac Biolot 100 is a dedicated preparative liquid chromatography system engineered for high-fidelity purification of therapeutic monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), Fc-fusion proteins, and other biopharmaceutical macromolecules. It operates on the principle of pressure-driven liquid-phase separation using packed-bed chromatographic columns—enabling robust, scalable, and reproducible purification across analytical to gram-scale preparative workflows. Designed specifically for biologics process development, the system supports all major chromatographic modalities including Protein A affinity, ion exchange (IEX), hydrophobic interaction (HIC), size exclusion (SEC), and multimodal chromatography. Its medium-to-low pressure architecture (up to 20 MPa) ensures compatibility with rigid, high-flow-resistance resins commonly used in antibody polishing steps—while maintaining low shear stress critical for preserving conformational integrity and biological activity.
Key Features
- Modular, PEEK-fluidic architecture with full bio-inert wetted path—eliminating metal leaching and minimizing protein adsorption or denaturation.
- High-precision dual-plunger PEEK piston pump delivering stable flow from 0.01 to 100.00 mL/min with ≤0.5% RSD and <0.2 MPa pressure pulsation—essential for gradient fidelity and column longevity.
- Dual-wavelength UV/Vis detector (190–800 nm) with automatic lamp switching (deuterium + tungsten), ±1 nm wavelength accuracy, and real-time dual-channel absorbance monitoring at 280 nm and 254 nm for simultaneous protein and nucleic acid tracking.
- Integrated conductivity and pH detection modules—enabling real-time monitoring of buffer composition and elution profiles during IEX or mixed-mode separations.
- Automated fraction collector with dual 60-tube racks (15 mm × 150 mm), supporting sequential, timed, peak-triggered, and loop-collection modes—including customizable trigger thresholds based on UV slope, area, or conductivity deviation.
- Onboard pump head auto-cleaning function using programmable solvent flush sequences—preventing salt crystallization and buffer carryover between runs.
- Gradient generation via high-resolution binary solvent mixing (ABS), supporting linear, step, and custom non-linear gradients with ±0.5% AB% resolution and dynamic online adjustment during method execution.
Sample Compatibility & Compliance
The Biolot 100 accommodates sample loads ranging from sub-milligram exploratory fractions to multi-gram purification batches—ideal for early-stage method scouting, resin screening, and lab-scale process validation. Its PEEK-based fluidic path meets ISO 10993-5 cytotoxicity requirements and exhibits negligible binding toward IgG subclasses, bispecifics, and glycosylated variants. The system complies with GLP and GMP-aligned operational frameworks: all hardware events, parameter changes, user logins, and method executions are time-stamped and cryptographically signed within the audit trail. BioView software is validated per FDA 21 CFR Part 11 requirements—including electronic signatures, role-based access control, and immutable data archiving—making it suitable for regulated environments supporting IND-enabling studies and comparability assessments.
Software & Data Management
BioView is a Windows-native, multi-module control platform supporting method building, real-time visualization, automated reporting, and raw data export in vendor-neutral formats (e.g., .csv, .pdf, .axd). It enables full method serialization—including gradient tables, collection logic, detector settings, and valve sequencing—with version-controlled storage and rollback capability. All chromatograms, calibration logs, maintenance records, and user actions are retained in a relational database with configurable retention policies. Exported datasets conform to ASTM E1957 and ISO/IEC 17025 traceability standards. Optional integration with LIMS via OPC UA or RESTful API facilitates enterprise-level data aggregation and QC release workflows.
Applications
- Monoclonal antibody capture and polishing (Protein A → CEX → SEC cascade)
- Removal of host cell proteins (HCP), DNA, aggregates, and leached Protein A ligand
- Purification of bispecific antibodies and antibody fragments (Fab, scFv, nanobodies)
- Process characterization studies under varying pH, conductivity, and gradient slope conditions
- Resin lifetime evaluation and cleaning-in-place (CIP) protocol optimization
- Supporting DOE-driven DoE (Design of Experiments) for QbD-compliant process development
- Preparative isolation of viral vectors (AAV, lentivirus) and plasmid DNA intermediates
FAQ
Is the Biolot 100 compatible with high-resolution analytical columns for method transfer?
Yes—the system’s low-dead-volume flow path (<12 µL from pump to detector) and precise gradient delivery support seamless transfer from analytical (e.g., 4.6 mm ID) to semi-preparative (10–21.2 mm ID) columns.
Can the system be validated for use in regulated biomanufacturing environments?
Yes—BioView software includes full 21 CFR Part 11 compliance features, IQ/OQ documentation templates, and third-party validation support services.
Does the system support pH gradient elution for IEX applications?
Yes—integrated pH detection and programmable mobile phase blending enable precise pH-controlled elution profiles, critical for charge variant separation.
What column hardware interfaces are supported?
Standard 1/4″-28 UNF and M10 × 1 fittings; compatible with commercial prep columns from Cytiva, Tosoh, Agilent, and Resolute.
Is remote monitoring and control available?
Yes—via secure RDP or web-based dashboard (optional add-on), allowing real-time status checks, alarm notifications, and limited parameter adjustments from off-site locations.
