The Industry’s First GMP-Compliant AUC Platform for Gene Therapy Development
In gene therapy, accurate and complete characterization of AAV and other viral vectors is essential to ensure product safety, efficacy, and regulatory approval. A critical parameter for FDA and EMA filings is the precise quantitation of empty, partial, and full capsids, as these directly impact therapeutic potency, dose accuracy, and patient safety.
While several GMP-compliant options exist for empty/full capsid ratio analysis, Analytical Ultracentrifugation (AUC) remains the gold standard for direct, label-free, and high-resolution measurement of capsid content. With BASIS 2.0, BioAnalysis delivers the only fully validated, end-to-end GMP-compliant AUC through a CRO, setting a new standard for speed, throughput, and compliance.
The Limitations of GMP Workarounds for AUC
Many organizations attempt to adapt AUC into a GMP environment by building workarounds — layering manual data handling, screenshots, non-validated software, or pieced-together audit trails to satisfy regulatory expectations. While these approaches can achieve a degree of compliance, relying on traditional SEDFIT or ULTRASCAN AUC software without GMP alignment often requires:
- Excessive manual review of raw data and calculations
- Extended turnaround times
- Increased regulatory risk
- Greater potential for discrepancies during regulatory review
These workarounds not only slow down the submission process but also increase the potential for errors that can delay your program.
Even when instrument manufacturers offer GMP-ready software with features like user roles, audit trails, and electronic signatures, the compliance work is far from finished. Each lab is still responsible for performing its own Computer Software Validation (CSV), a rigorous process that demonstrates the software functions correctly across every workflow, from installation through analysis. A thorough CSV can exceed 100 pages and must be repeated with every software update. For many organizations, this represents a significant and often unexpected investment of time, expertise, and resources.
Introducing BASIS™ 2.0: Next-Generation GMP-Compliant AUC
BioAnalysis has solved the GMP AUC challenge with BASIS™, our proprietary, 21 CFR Part 11–compliant software platform designed specifically for cGMP workflows. BASIS integrates seamlessly with SEDFIT, a globally recognized AUC analysis engine.
Now with BASIS™ 2.0, we’ve taken GMP AUC to the next level:
3x Higher Throughput
Fit three data sets simultaneously, dramatically increasing processing capacity.
One-Click Workflow
Direct instrument communication allows operators to download and analyze data in a single click.
Built-in Methods
Instrument methods integrated directly into the software for enhanced convenience and security.
Secure Data Integrity
Full compliance with FDA data integrity requirements and comprehensive audit trails.
Streamlined Reporting
Automated capture of experimental details, raw data, and final analysis in a single validated package.
Fewer Error Sources
Direct instrument-to-analysis communication eliminates manual data handling touchpoints.
Expert Oversight
Raw data surfaces at key checkpoints, ensuring trained analysts catch what automation might miss.
With BASIS™ 2.0, BioAnalysis is the leading service organization offering cGMP-compliant Analytical Ultracentrifugation (AUC) as part of a validated workflow for gene therapy clients. Our comprehensive Computer Software Validation (CSV), maintained and updated by BioAnalysis with every release, means your team never carries the burden of writing or executing a CSV. This innovation provides sponsors with the confidence that their empty/partial/full capsid quantitation is supported by robust, regulatory-ready biophysical data.
Why BioAnalysis?
At BioAnalysis, we combine cutting-edge biophysical methods with regulatory-grade compliance to support CDMOs and gene therapy developers from early research through IND/BLA submissions. Our GMP-compliant AUC workflow, powered by BASIS™ 2.0, ensures:
- Reliable, reproducible, and auditable results
- Higher throughput with direct data download and parallel analysis
- Reduced manual intervention and fewer error sources
- A defensible analytical package aligned with FDA expectations
- Complete Computer Software Validation, performed and maintained by BioAnalysis so your team doesn’t have to
By delivering both innovative tools and regulatory expertise, BioAnalysis empowers gene therapy companies to bring safe and effective treatments to patients with confidence.
Ready to streamline your GMP AUC workflow? Contact our AUC experts to learn how BASIS™ 2.0 can accelerate your gene therapy program.