Since establishing GMP-compliant operations in January 2021, BioAnalysis has become a trusted partner for CDMOs and pharmaceutical companies advancing next-generation biologics. In just a few years, we have successfully completed 26 client audits—all without a single critical finding—and passed an unscheduled FDA inspection with no major observations. Our systems and documentation are designed to align with both FDA and EMA expectations.
Our laboratories feature qualified, validated instrumentation to enable GMP-compliant assays across key technologies, including:
- Biophysics (AUC, DLS) – structural characterization, aggregation analysis, capsid and particle profiling
- Mass Spectrometry (LCMS) – identity, purity, peptide mapping, PTMs, and impurity detection
- Chromatography (HPLC) – excipient testing, VP ratios, residual analysis, and stability monitoring
We provide comprehensive GMP analytical solutions for a wide range of biologics, including:
- Viral Gene Therapies (AAV, lentivirus, oncolytic viruses) – empty/partial/full capsid quantitation, capsid ID, VP ratios, aggregation, and impurity/residual testing
- Lipid Nanoparticles (LNPs) – particle size distribution, encapsulation efficiency, aggregation, and excipient profiling
- Monoclonal Antibodies (mAbs, ADCs, AOCs) – PTMs, glycosylation profiling, aggregation, and stability studies
In addition to development-phase analytics, BioAnalysis supports GMP release and stability testing for commercial products, helping ensure long-term product quality, safety, and regulatory compliance.
With a proven GMP track record, zero critical findings, and expertise across multiple biologic modalities, BioAnalysis provides the confidence and reliability CDMOs and pharmaceutical companies need to accelerate development, de-risk regulatory submissions, and deliver safe, effective therapies to drug developers worldwide.