The Significance of Analytical Method Development
Analytical method development, validation, and transfer are integral to any small or large-molecule drug development program. Analytical methods can be developed to establish the identity, purity, physio-chemical and structure characteristics, process or product-related impurities of the drug substance (DS), active pharmaceutical ingredient (API), and drug products (DP).
To ensure consistent scientific integrity of the method and ultimately patient safety, all analytical methods used in the analysis of drugs or DS for regulatory submission must be must be validated as required by regulatory authorities at various stages of the development and approval process. Rigorous method validation establishes the accuracy, precision, linearity, specificity, selectivity, range, limits of detection and quantitation, and robustness of an analytical method.
Analytical Method Development Services of Yaohai Bio-Pharma
Yaohai Bio-Pharma provides flexible and customized analytical solutions, including phase-appropriate analytical method development and validation. Our team has significant expertise in analytics for all stages of the biologics development lifecycle, from early-stage protocols to late-stage quality control method optimization. Tests are designed in consideration of the relevant Pharmacopoeia (EU and US monographs), regulatory guidelines (ICH, FDA, and EMEA), and GMP/GLP practices.
We are experts in Analytical Method Development for Proteins and Plasmid DNA.
Service Details
- Method Development and Optimization for in-process controls, release, and stability studies
- Analytical Method Qualification/Validation
- Quality Control (QC) and Stability Studies of research batches
- Reference standard generation and characterization
- Product Characterization (biochemical, biophysical, biological); Comparability and Similarity Assessment
- Technology transfer to QC
Modalities
Recombinant Proteins/peptides Analysis
e.g., Recombinant Vaccines, VHH/Nano-Antibodies, Antibody Fragments, Hormones, Cytokines, Growth Factors, Enzymes, Collagens, Fusion or Conjugated Proteins and any other microbial-based Proteins/Peptides.
Plasmid DNA (pDNA)
e.g., Naked Plasmids, DNA vaccines, and DNA Materials for mRNA or Virus -Vectored Gene Therapy.
Related Services
Quality Control (QC) and Stability Studies
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