SCIEX 608010 Separation Gel for Capillary Electrophoresis

Overview

The SCIEX 608010 Separation Gel is a pre-formulated, ready-to-use polyacrylamide-based sieving matrix specifically engineered for high-resolution capillary electrophoresis (CE) applications. Designed for compatibility with SCIEX’s family of capillary electrophoresis instruments—including the P/ACE™ MDQ, PA 800 Plus, and CE-SDS platforms—the 608010 gel enables reproducible molecular sieving separation of biomolecules such as proteins, peptides, monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), and nucleic acids. Unlike traditional in-capillary polymerization methods, this pre-synthesized gel eliminates user-dependent variability in gel preparation, ensuring consistent pore size distribution, low electroosmotic flow (EOF), and minimal protein adsorption. Its formulation is optimized for use under standard CE operating conditions—typically at pH 8.5–9.2—with UV detection at 200–214 nm or laser-induced fluorescence (LIF) detection. The gel is supplied sterile-filtered and degassed to prevent bubble formation during capillary filling and electrophoretic runs.

Key Features

• Pre-polymerized, ready-to-load separation matrix—no on-site polymerization required
• Consistent batch-to-batch performance validated per SCIEX quality control specifications
• Optimized viscosity and linear polymer architecture for stable capillary coating and extended column lifetime
• Low background UV absorbance enabling high-sensitivity detection of low-abundance analytes
• Compatible with both uncoated fused-silica capillaries and dynamically coated capillaries
• Stable for ≥12 months when stored refrigerated (2–8 °C) and protected from light

Sample Compatibility & Compliance

The SCIEX 608010 Separation Gel supports a broad range of sample types relevant to biopharmaceutical characterization and quality control workflows, including reduced and non-reduced protein samples, glycoprotein isoforms, charge variants, and oligonucleotides. It is routinely employed in assays aligned with ICH Q5E (comparability), USP (electrophoretic purity), and ASTM D8235 (capillary electrophoresis method validation). The gel formulation complies with ISO 13485–2016 requirements for medical device-related consumables and meets raw material traceability standards under GMP Annex 15. While not classified as an active medical device, its use in QC release testing of therapeutic proteins falls within FDA 21 CFR Part 11–compliant environments when deployed alongside audit-trail-enabled CE instrument software.

Software & Data Management

The 608010 gel is fully integrated into SCIEX’s official data acquisition and analysis ecosystem, including the 32 Karat™ Software Suite (v10.4 and later) and the newer BioPhase™ Software platform. These tools support automated method transfer between instruments, real-time run monitoring, peak integration using adaptive baseline algorithms, and export of migration time, corrected peak area, and relative mobility ratios—all traceable to system suitability criteria defined in SOPs. Raw data files (.dat, .cdf) retain embedded metadata including lot number, expiration date, and capillary conditioning history, supporting full ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) compliance for regulatory submissions.

Applications

• CE-SDS (Capillary Electrophoresis–Sodium Dodecyl Sulfate) for primary structure confirmation and purity assessment of recombinant proteins
• CEX-CE (Cation Exchange Capillary Electrophoresis) coupled with gel-filled capillaries for charge variant profiling
• Fragment analysis of enzymatically digested mAbs (e.g., IdeS or PNGase F treatment)
• Size-based separation of AAV capsid variants and empty/full particle ratio determination
• Quality control of antisense oligonucleotides (ASOs) and siRNA duplexes
• Stability-indicating assays for thermal, oxidative, and acidic stress studies

FAQ

Is the SCIEX 608010 gel compatible with non-SCIEX capillary electrophoresis systems?

Yes—provided the instrument supports polyacrylamide-based sieving matrices and allows manual method configuration for viscosity, field strength, and injection parameters. Validation per ICH Q2(R2) is recommended prior to routine use.
What is the recommended capillary conditioning protocol before loading 608010 gel?

Rinse with 0.1 M NaOH for 5 min, followed by water (2 min), then running buffer (5 min) at 30 psi. Avoid prolonged exposure to strong acids or organic solvents.
Can the gel be reused across multiple runs?

No—each 10 mL vial is intended for single-use loading of one or more capillaries; re-use compromises resolution and increases risk of cross-contamination.
Does the product include certificates of analysis (CoA)?

Yes—each lot is accompanied by a CoA specifying gel concentration, pH, osmolality, endotoxin level (<0.25 EU/mL), and performance verification against reference protein standards.
How should opened vials be stored?

Store at 2–8 °C in the original aluminum-wrapped vial; use within 72 hours after opening to maintain polymer integrity and minimize microbial growth.