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Analytical Services
개요
A good strategy and solution will advance your success
Good Strategy and Solution Will Advance Your Success

Strategy

Solution

Startup biotechnology companys' should consider all scientific and regulatory aspects from development to approval of a product.
Proper strategy, methodology and experiments will be thoroughly prepared for the approval or license-out of biotechnology-derived proteins.
서비스 범위

Our service area is a necessity and will add value to your product

Based on Regulatory Requirements and Guidelines

  • Analytical
    Method
    Development

  • Quality Evaluation

  • Characterization (Comparability &
    Similarity)

  • Market Launch

Analytical Method Development of Biotherapeutics

  • Analytical Method Development by QbD
  • Qualification
  • Validation
  • Data Analysis and Interpretation from Physicochemical and
    Structural Approaches
    • - Physicochemical Properties
    • - Mass Spectrometry Analysis
    • - Higher Order Structure

Strategy for Characterization Study

  • Strategy of Comparability Study
    • - Comparability Range
    • - Sample Set
    • - Test Method
    • - Structure-Activity Study (SAR)
  • Strategy of Similarity Study (e.g. in Biosimilar Development and Approval)
    • - Approach for Similarity Study
    • - Set-up of Similarity Range
    • - MOA-based Test Method
  • Stability Study
    • - Strategy of Stability Study (e.g. formal, stress, accelerated stability study, etc)

Quality Evaluation

  • Quality Risk Management Risk Assessment
  • Set-up of CQA/Tier System
  • Analytical strategy
  • Justification of Specification for Approval
    • - Data set
    • - Statistical Approach
    • - Method for Justification of OOS OOR
    • - Detailed Description

Educational Service

  • Presentation for Each Service Area
  • Education for All Service Areas