Peptide Bioassays and Safety Studies at Daicel

FDA recommendations on synthetic peptides that refers to listed drugs of rDNA origin

Active Ingredient Sameness

  • Primary Sequence and Physico Chemical Properties
  • Secondary Structure Analysis
  • Oligomer/ Aggregate states
  • BIOLOGICAL ACTIVITY

Impurities

  • Peptide Related Impurities
  • New impurity that is not found in RLD
  • Safety Assessment by non-clinical IMMUNOGENICITY

BIOLOGICAL ACTIVITY (Bioidentity; Specific Activity/Potency)

  • cAMP/Secondary Messenger Assays
  • Proliferation Assays
  • Binding Assays
  • Reporter Gene Assays

Key Advantages with Daicel

  • Clean Room/Classified Suite (ISO 8 /Class 100000) for Bioassay and safety assessment studies
  • Data Integrity – FDA 21 CFR Part 11 compliance SoftMax┬« Pro 7.1.1 GxP Software for Data capture
  • Strong scientific team on board with statistical experience
  • Validations as per International Regulatory Guidelines, such as USP/EP, US FDA, EMA, ISO and ICH
  • Multimode Plate Reader with Absorbance, Luminescence (with Alpha screen) and Fluorescence readouts
  • Data Analysis using validated PLA Software
  • Other Data Analysis Tests such as T-test, ANOVA for Statistical hypothesis
  • Cell Banking & Characterization
  • Training & Technology Transfer
  • Regulatory Guidance by Experts