Service for Process Development

Taking advantage of AmProteinÂżs revolutionary expression system, cell development process and advanced bioreactor systems, we can provide high quality and efficient process development services to our customers.

This service includes:

  1. Protein Design & Engineering Strategy
  2. Gene Transfection Process
  3. High-yielding Cell Line Selection Process (detection and bio-activity method)
  4. Mini-bioreactor Process Development & Primary Media Optimization
  5. Small Bioreactor Process Development & Secondary Media Optimization
  6. Larger Bioreactor Process: Suspension or Perfusion & Commercial Final Media Determination
  7. Purification Strategy and Process (endotoxin host cell protein and rDNA method development)
  8. Formulation Process
  9. In-vivo animal testing for bio-activity (toxicity, efficacy & PK):
  10. Small & large animal short term toxicity studies
  11. Radio-labeled protein will be used for small and large animal live imaging and blood PK
  12. Disease models and drug efficacy

Service for Chemicals, Manufacture & Control Information (CMC)

Taking advantage of its past experience of the FDA's standard CMC filing process and its biopharma alliance, AmProtein provides CMC service after the cell line and process development.

This service includes:

  1. Cell Banking: Cell line genetic background and mRNA expression of the protein of interest
  2. Overlapping Peptide Mapping followed by full amino acid sequencing
  3. Sialic Acid (Sugar) Quantitative Assay to monitor batch-to-batch product quality
  4. Trypsin Peptide Mapping to monitor batch-to-batch product quality
  5. Amino Acid Components Assay to monitor batch-to-batch product quality
  6. Bio-assays to monitor batch-to-batch product quality
  7. Formulation & Stability Studies to monitor batch-to-batch product quality