Agile BioScience

SV-AUC

SV-AUC Analysis Services for Advanced Biopharmaceutical Characterization

Accurate sedimentation velocity analytical ultracentrifugation (SV-AUC) testing for protein aggregation, capsid analysis, and biosimilarity studies. Confidently advance your candidates with gold-standard, regulatory-ready data.

  • FDA/EMA-compliant analytical methods 
  • Expertise in high concentration protein SV-AUC testing 
  • Trusted by global biopharma and CRO partners 
  • 1000+ successful protein characterization projects
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Comprehensive SV-AUC Analysis Services

In the high-stakes world of biopharmaceuticals, what you can’t see can derail a multi-million dollar program. You need absolute confidence in the purity, stability, and integrity of your molecules—from monoclonal antibodies to complex viral vectors. That’s where Sedimentation Velocity Analytical Ultracentrifugation (SV-AUC) comes in.

Think of SV-AUC as a high-definition camera for your molecules in their natural state. Unlike methods that require columns or surfaces that can alter your sample, SV-AUC analyzes molecules directly in solution as they separate under centrifugal force. This provides an unbiased, gold-standard view of critical quality attributes like protein aggregation, the ratio of empty to full viral capsids, and overall molecular homogeneity.

Our SV-AUC analysis services are designed to give you that unparalleled clarity, supporting you from early development through regulatory submission.

Our Core Analytical Capabilities

Protein Aggregation Analytics for Biosimilarity Using SV-AUC


Aggregation isn’t just a number; it’s a potential risk to safety and efficacy. For biosimilar developers, proving you match the originator’s aggregation profile is non-negotiable.

  • Keyword Focus: Aggregation analytics for biosimilarity using SV-AUC
  • Application: Quality Control (QC), Biosimilar Comparability Studies, Lot Release Testing.
  • Our Approach: We provide a detailed quantitative analysis of monomers, dimers, and higher-order aggregates with a level of sensitivity that other methods often miss, giving you a definitive picture for a robust comparability exercise.

Capsid Characterization: Empty vs. Full Analysis


In gene therapy, the potency of your AAV product is directly tied to the percentage of capsids containing the full genetic payload. Accurately distinguishing empty from full capsids is critical.

  • Keyword Focus: Characterization of empty vs full capsids SV‐AUC
  • Application: AAV Gene Therapy Vector Analysis, Viral Vector QC.
  • Our Approach: SV-AUC is one of the few techniques that can directly and quantitatively resolve empty, partial, and full capsids without labels or staining, providing essential data for optimizing your purification process and ensuring product quality.

High-Concentration Protein Testing


Therapeutic proteins, especially monoclonal antibodies (mAbs), are often formulated at high concentrations where interactions and aggregation can be concentration-dependent. Testing at these relevant conditions is vital.

  • Keyword Focus: High concentration protein SV-AUC testing
  • Application: High-concentration mAb Formulations, Subvisible Particle Analysis.
  • Our Approach: We specialize in high concentration protein SV-AUC testing, overcoming the limitations of techniques like SEC that can struggle at clinically relevant concentrations. This allows you to see how your molecule truly behaves in its final formulation.

Benefits of Choosing Agile BioScience:

  • ​Confidence in Aggregation Assessment: Gain a comprehensive understanding of aggregation in your product, especially the critical sub-100nm range.
  • Problem-Solving Support: Identify the root causes of aggregation and optimize formulation conditions to minimize aggregate formation.
  • Regulatory Readiness: Thoroughly characterize aggregates to support regulatory submissions and quality control.
Contact us to learn how SV-AUC can strengthen your biopharmaceutical development.

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Who We Serve: Empowering Innovation Across the Life

Sciences

Our SV-AUC analysis services are tailored for organizations where data quality drives decisions:

  • Biopharmaceutical Companies developing monoclonal antibodies, fusion proteins, and other complex therapeutics.
  • Gene Therapy Developers working on AAV and other viral vectors.
  • Biosimilar Manufacturers requiring robust comparability data for regulatory approval.
  • CROs and CDMOs seeking a reliable partner to extend their analytical capabilities.
  • Academic Research Institutes conducting cutting-edge biomolecular research.
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Applications of SV-AUC in Biopharmaceutical Development

SV-AUC is a versatile tool that answers critical questions throughout the development lifecycle. Here’s how it’s applied in real-world scenarios:

Resolving the Debate: SV-AUC vs SEC Aggregation Results


When you need the most accurate picture of protein aggregation, SV-AUC is the definitive method. It operates in a near-native state, avoiding the shear forces and surface interactions of an SEC column that can dissociate weak aggregates or create new ones. The result? You get a true measure of solution heterogeneity, often revealing species that SEC cannot detect.

Ensuring Potency: Characterization of Empty vs Full Capsids with SV-AUC


For gene therapies, the empty/full capsid ratio is a direct critical quality attribute (CQA). SV-AUC provides a label-free, quantitative analysis that is orthogonal to methods like TEM or AUC, making it indispensable for process development and lot release testing of AAV products.

Real-World Formulation Insights: High Concentration Protein SV-AUC Testing


Does your high-concentration mAb formulation remain stable? Our high concentration protein SV-AUC testing services allow you to analyze your proteins at therapeutic concentrations, providing crucial insights into aggregation propensity under relevant conditions that SEC-MALS simply cannot handle.

De-Risking Submissions: Aggregation Analytics for Biosimilarity Using SV-AUC


Proving biosimilarity requires demonstrating that your product’s impurity profile matches the reference product. SV-AUC’s sensitivity and accuracy make it the preferred method for this head-to-head comparison, providing the robust data package needed to satisfy regulatory agencies.

SV-AUC vs. SEC: A Clear-Cut Comparison for Informed Decision-Making

 

Analytical Aspect

SV-AUC (Sedimentation Velocity)

SEC (Size Exclusion Chromatography)

Sensitivity & Resolution

Higher. Detects small populations of aggregates and fragments with excellent resolution.

Lower. Limited resolution can miss low-abundance or similar-sized species.

Sample Concentration

Excellent. Handles high concentration protein solutions relevant to therapeutics.

Limited. Column performance degrades at high concentrations, leading to artifacts.

Capsid Analysis

Ideal. Can directly distinguish empty, partial, and full viral capsids.

Not Suitable. Cannot reliably resolve empty vs. full capsids.

Sample Environment

Near-native solution state, minimal perturbation.

Requires column passage, risking interaction, shear, or dilution.

Regulatory Acceptance

Gold-standard for aggregation and capsid analysis in regulatory submissions.

Supportive data, but often not considered standalone for critical comparisons.

Case Study: Validating Biosimilarity for a Monoclonal Antibody

The Challenge: A leading biosimilar developer needed to conclusively demonstrate that the aggregation profile of their monoclonal antibody candidate matched the originator product for an FDA submission. Initial data from SEC was inconclusive and showed variability.

Our Solution: We deployed our SV-AUC analysis services for a head-to-head comparison. The high-resolution data provided a definitive, quantitative breakdown of monomer and aggregate content, revealing a near-identical profile to the reference product that SEC could not resolve.

The Outcome: The robust, high-quality SV-AUC data became a cornerstone of the analytical comparability package. It provided the clear evidence needed to satisfy regulatory concerns, significantly de-risking the review process and helping to pave the way for a successful submission.

FAQ About SV-AUC Services

Q1. What is sedimentation velocity analytical ultracentrifugation (SV-AUC)?


In simple terms, SV-AUC is a powerful analytical technique that spins a sample at high speeds to separate molecules based on their size and shape. As they sediment through a solution, we can precisely measure how they move, giving us a detailed picture of what’s in your sample—from tiny fragments to large aggregates—all without needing columns or tags that can interfere with the results.

Q2. How does SV-AUC compare to SEC for aggregation testing?


This is a key question. The main difference is environment. SEC forces your sample through a column, which can sometimes break apart weak aggregates or cause the protein to stick, giving an inaccurate reading. SV-AUC observes your molecules floating freely in solution, providing a more natural and often more sensitive snapshot of the true aggregation state. This is why we often see differences when comparing SV-AUC vs SEC aggregation results.

Q3. Can SV-AUC distinguish empty vs full viral capsids?


Yes, absolutely. This is one of its standout applications. Because empty and full capsids have different masses (the DNA payload adds significant weight), they sediment at different rates. SV-AUC can cleanly separate and quantify these populations, making it a gold-standard method for the characterization of empty vs full capsids SV-AUC in AAV gene therapy products.

Q4. Is SV-AUC suitable for high concentration protein testing?


Yes, and this is a major advantage. Many proteins, especially mAbs, are delivered at high concentrations. SEC often fails at these concentrations because the column gets overloaded. SV-AUC, however, is well-suited for high concentration protein SV-AUC testing, allowing you to analyze your product under conditions that closely mimic its final therapeutic form.

Q5. Do regulatory agencies accept SV-AUC data for biosimilar submissions?


Without a doubt. Regulatory bodies like the FDA and EMA recognize SV-AUC as a gold-standard, orthogonal method for characterizing complex molecules. Its data is highly respected for critical assessments like biosimilarity exercises, where proving an identical aggregation profile to the reference product is essential. Our reports are designed to meet strict regulatory standards.

Get Accurate SV-AUC Analysis for Your Biopharmaceuticals

Don’t let uncertainty about protein integrity, aggregation, or capsid content slow your progress. Partner with a team that provides the clarity and confidence you need to move forward.

Ensure your product’s quality and de-risk your regulatory pathway with our expert SV-AUC services.

Fill out the form below to request a consultation with our scientists. We’ll review your specific needs and provide a tailored plan to get you the definitive data your program requires.

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