BioAnalysis LLC


BioAnalysis LLC is a collaborative research organization dedicated to providing high-quality analytical testing services for gene therapy, biotherapeutics, and life sciences industries. Located in Philadelphia’s Kensington neighborhood, the company emphasizes scientific excellence, community impact, and innovative biophysical and analytical methods to support biologic drug development and manufacturing.

Industries

analytics
biopharma
consulting

Nr. of Employees

small (1-50)

BioAnalysis LLC

Philadelphia, Pennsylvania, United States, North America


Products

cGMP‑compliant AUC data analysis software

Secure software package for capturing, analyzing and reporting AUC experiments in a cGMP‑capable workflow; integrates standard AUC analysis tools and is designed for part 11–compatible audit trails and reporting.


Services

Biophysics (AUC, DLS)

AUC and DLS laboratory services for capsid occupancy analysis, aggregation, stability, size distribution and formulation support; offers both SV‑AUC and density equilibrium AUC workflows.

Mass spectrometry (LC‑MS) services

High‑resolution LC‑MS assays including peptide mapping, intact mass, HCP identification, PTM mapping and analyses for mRNA/LNP and vaccine modalities; available under GMP conditions.

Chromatography and HPLC services

HPLC and chromatographic method development, impurity profiling, residual assays, stability and release testing using SEC, RP, IEX, HILIC and detectors such as charged aerosol, UV/VIS and fluorescence.

Molecular biology support

Molecular biology assays and support for gene therapy and biologics testing workflows (service described on company site as part of service offerings).

cGMP analytical services and regulatory support

End‑to‑end analytical services conducted under qualified cGMP conditions, including equipment qualification, documentation, audit support and GMP‑compliant reporting.

Expertise Areas

  • Analytical ultracentrifugation (AUC) for gene therapy characterization
  • High-resolution mass spectrometry for biologics
  • Chromatographic method development (HPLC, SEC, RP, IEX, HILIC)
  • cGMP-compliant analytical testing and audit readiness
  • Show More (3)

Key Technologies

  • Sedimentation velocity analytical ultracentrifugation (SV‑AUC)
  • Density gradient equilibrium AUC
  • Dynamic light scattering (DLS)
  • Size‑exclusion chromatography with multi‑angle light scattering (SEC‑MALS)
  • Show More (7)

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