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BioPharma >> Comprehensive Cell and Gene Therapy Testing Capabilities >> Safety, characterization and release testing support

Safety, characterization and release testing support

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Eurofins BioPharma Product Testing Italy  provides comprehensive GMP compliant testing support to assess starting materials, intermediate products, vectors, and final drug products for their identity, potency, purity, and safety as well as support for manufacturing process development and validation.

Compendial
  • Visible Particles/Subvisible Particles
  • pH
  • Appearance
  • Osmolarity
Safety
  • Sterility
  • Rapid Sterility
  • Mycoplasma (Compendial and NAT methods)
  • Endotoxin
  • Low Endotoxin Recovery (LER)
  • Monocyte Activation Test (MAT)
  • Adventitious Virus (in Vitro and PCR)
  • Replication Competent Virus (e.g., rc-AAV, RCL, RCR, RCA)
Process Residuals
  • Host cell protein
  • Residual DNA
  • Residual plasmids
  • Benzonase
  • PEI
  • Tween
Characterization
  • Purity
  • Empty/Full Capsid
  • Aggregation
  • Capsid Content/Physical titer
  • Genomic Titer
  • Infectious Titer
  • Potency
  • Capsid Identity
  • Vector Genome Identity
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If you’re interested in working with Eurofins, fill out the form below and a member of our Team will be in contact to discuss your project.

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