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 capsid ratio analysis, AUC remains the gold standard for direct, label-free, and high-resolution measurement of capsid content.  BioAnalysis is proud to be among the first in the space to provide GMP-compliant AUC to fill this need.   

The Limitations of GMP Workarounds for AUC
Many organizations attempt to adapt AUC into a GMP environment by building workarounds—for example, layering manual data handling, non-validated software, or pieced-together audit trails to satisfy regulatory expectations. While these approaches can achieve a degree of compliance, relying on traditional AUC software without GMP alignment often requires excessive manual review of raw data and calculations, extended turnaround times and increased regulatory risk.  These workarounds not only slow down the submission process but also increase the potential of discrepancies during regulatory review. 

Introducing BASIS™: The First GMP-Compliant AUC Software
BioAnalysis has solved this challenge with BASIS™, our proprietary, 21 CFR Part 11–compliant software platform designed specifically for cGMP workflows. BASIS integrates seamlessly with SEDFIT, the globally recognized AUC analysis engine, to deliver: 

• Secure Data Integrity – Full compliance with FDA data integrity requirements and audit trails. 

• Streamlined Reporting – Automated capture of experimental details, raw data, and final analysis in a single validated package. 

• Accelerated Speed – Eliminates inefficient GMP workarounds, reducing manual review and integration time. 

• Flexible Use – Applicable across R&D, non-GMP, and GMP environments for consistent data continuity. 

With BASIS™, BioAnalysis is the leading service organization offering cGMP-compliant Analytical Ultracentrifugation (AUC) as part of a validated workflow for gene therapy clients. 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™, ensures: 

• Reliable, reproducible, and auditable results. 

• Faster turnaround with reduced manual intervention. 

• A defensible analytical package aligned with FDA expectations. 

By delivering both innovative tools and regulatory expertise, BioAnalysis empowers gene therapy companies to bring safe and effective treatments to patients with confidence.