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US Locations >> San Diego, CA >> San Diego's CMC Testing
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CMC Testing Engineered for Virtual & Small Pharma Companies

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Eurofins BioPharma Product Testing's lab in San Diego provides analytical and formulation development expertise in all dosage forms and API’s ranging from small molecules to large molecules, including peptides, proteins, oligonucleotides and RNAs. The GLP and cGMP compliant lab services encompass Pre-formulation & Formulation, Analytical Method Development & Validation, Routine QC & Monograph Testing, Clinical Material Labeling/Packaging and Regulatory Consultancy. Eurofins BioPharma Product Testing's lab in San Diego has also added 1,500 ft2 of non-sterile manufacturing capabilities.

CMC Testing

Analytical Development & Validation

  • Method Development, Qualification & Validation
  • Method Optimization & Remediation
  • Analytical Support of Pre-Formulation & Dose Stability
  • Residual Solvents Analysis
  • Forced Degradation Studies
  • Stability Study, Storage and Release Testing
  • Topical in vitro assays

Routine QC & Monograph Testing

  • Raw Material & Excipient Screening
  • Intermediates & API Characterization
  • In-process and Finished Product Testing
  • Toxicology Test Article Dose Verification & Short-term Stability
  • Degradent, Impurity and Related Substance Identification
  • Reference Standard Characterization & Stability
  • High Potency Testing capabilities for cytotoxics, B-lactams, and mutagens
  • LCMS & ELISA Quantitative Assays
  • BSL-2 containment to isolate dangerous biological agents

Formulation, Manufacturing & Support Services

Eurofins BioPharma Product Testing's lab in San Diego provides additional services to support the drug development process:

Formulation Development & Optimization

  • Liquids (solutions, suspensions, emulsions)
  • Topicals (creams, ointments, gels, lotions)
  • Comparator Testing
  • Compatibility Testing (bags/sets, ports, etc.)
  • Solubility and Stability Screening
  • Toxicology Formulation and Test Article Preparation
  • Lyophilization Formulation Development

GMP Manufacturing (Non-Sterile)

  • Technology Transfer
  • Process Development
  • Dosage Forms (topicals, solutions, reagents, powders)
  • Active Pharmaceutical Ingredients (Atypical APIs)
  • Clinical Trial Materials

Clinical Material Labeling & Packaging

  • Kitting
  • Labeling
  • Storage & Distribution
  • Reconciliation & Destruction