Analytical Method Development

Establish precise analytical test methods to ensure the integrity of your product.

The early-stage drug products we manufacture are often first-in-clinical, first-in-human products. This makes sterility assurance and safety data critical. We work to develop reliable test methods for factors like potency, percent encapsulation and degradation—customized for your drug’s manufacturing and storage conditions. At the end of the day, patients’ lives depend on our ability to select test methods we can have confidence in time after time.

• We can develop new methods or work with your existing methods to determine feasibility and optimize your test procedures, taking into account instrument suitability, supplier qualifications and physicochemical properties of the drug molecules. 
  
  
• The primary deliverable resulting from this effort is a written procedure of each test method and correlating specification, including recommendations for further development and validation.
  
  
• When phase-appropriate, method validation procedures are then used to confirm the adequacy of each analytical test method, assuring that tests are reliable and meet global regulatory standards. 
  
  
• Statistical analysis of test data is used to demonstrate the validity of each method as we work to develop final analytical procedures.

Analytical Testing Capabilities

Analytical Technical Services: 

• Analytical Method Development & Troubleshooting and Process Development Analytical Support
• Method Qualifications/Validations/Transfers
• API and Raw Material Testing Per USP/NF/Ph.Eur.
• Sterile Injectable In-Process and Finished Drug Product Testing
• API, Raw Material, In-Process, and Finished Product Specification Development
• ICH and cGMP Stability Testing
• Complex Drug Product Testing for LNPs & Pegylated Formulations Involving Oligonucleotides, Proteins, Small & Other Large Molecules
• Dedicated Development Team of Highly Experienced, Qualified and Trained Scientists
• Dedicated Staff for cGMP & QC Routine Testing

Analytical Instrumentation and Equipment: 

• Multiple Waters Brand HPCLs and UPLCs with UV-PDAs/CADs/ELSDs/RI/Fluorescence, QDa, Single Quadrupole Mass Spectrophotometer & Multi Angle Light Scattering (SEC-MALS) Detectors
• Fluorescence/UV/Nanodrop/FT-IR Spectrophotometers
• CE/Fragment Analyzers
• ELISA Plate Readers
• Malvern Zetasizers (Nano S, Nano ZS90) & Mastersizer 2000
• Agilent Gas Chromatographs with FID/ECD/TCD Detectors & Headspace GC/FID
• SDS-PAGE and Western Blot
• Polarography Analyzer, Coulometric & Volumetric Karl Fishers, Auto Titrator
•  Centrifuges, Micro & Analytical Balances
• -800C & -200C Freezers
• Multiple c-GMP Stability Chambers
• 2-8C (walk-in)
• 23-27C/55-65%RH (two chambers)
• -15C to -25C (two chambers)
• -65C to -85C (one upright)

Drug Product Assay & Impurities: 

• Concentration Assays via HPCL & UPLC-UV/CAD, ELISA Assays for Proteins in LNPs & Pegylated Formulations
• Enzymatic Activity for PEGylated Proteins via UPLC/UV
• Ribogreen Assays for RNAs and Oligreen Assays for DNAs
• Drug Product Purity & Impurities via UPLC, SEC, CE/Fragment Analyzer
• Residual Solvents via GC Headspace, GC-FID, GC-ECD and GC-TCD

Liposomal/LNP Formulations: 

• Encapsulation & Free Drug Analysis for RNAs (Ribogreen), DNAs (Oligreen), Proteins (ELISA), Small molecules
• In-Vitro Release (IVR) Assays
• Lipids Assay & Impurities via HPLC & UPLC-CAD/ELSD/UV

Drug Product Physical Characterization: 

Particle Size & Distribution, Zeta Potential, pH, Osmolality (Freezing Point & Vapor Pressure), Extractable Volume, Viscosity, Turbidity, Density, HIAC Particle Counting.

Microbiology Testing: 

Endotoxin & Other Pyrogens, Bioburden, and Sterility

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