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General Services

Stability Studies

BBL has a twenty-four hour alarm-linked computer monitored temperature and humidity controlled facility for product stability and accelerated degradation studies. We provide complete analytical services for formulation testing as well as final product release testing. BBL operates under full GLP/cGMP compliance.

“Bay Bio Analytical has been a very good partner for Juvaris BioTherapeutics. They have performed GMP release assays and stability studies with appropriate quality and timeliness. BBL has reported data promptly, ensuring our projects met corporate goals. We have also appreciated their flexibility with analytical assay development and assay qualification.”

- Lee B. Bussey, Ph.D., Senior VP,
  manufacturing Juvaris BioTherapeutics

Other Services

  • Karl Fischer water analysis
  • Preformulation studies including solubility determination, Log D determination, and counterion characterization
  • Research/Discovery stage formulation for i.v., p.o, and i.p routes of administration

HPLC/GC Analyses

  • Method development and validation
  • Product characterization
  • Analysis of trace contaminants
  • Microbore HPLC
  • UV-Vis, RI, or fluorescence detection
  • Chromatographic modes available: normal and reversed phase, Ion exchange, size exclusion, affinity, HIC and HILIC
  • Laser Light Scattering

Gel Analyses

  • SDS Page: 1D and 2D
  • IEF
  • Western Blot
  • Nucleic Acids
  • Imaging and Quantitation

Spectroscopy

  • UV-Vis
  • Polarimetry (Optical Rotation)

Consulting

  • Chromatography training
  • Method development
  • Method validation
  • Stability assays
  • Formulation assays

Created by J Rooney Design