Cell Therapy
CliniMACS Prodigy®

AGC Biologics develops and manufactures diverse cell therapies including CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells. Our cell therapy capabilities cover numerous technologies, ranging from closed to open systems at different scales, depending on client needs. Our quality systems, facility layout and regulatory qualifications enable us to serve both clinical and commercial demands. Since we perform more than 100 analytical tests in-house, AGC Biologics reduces overall turnaround time. With experience manufacturing three commercial products, we are the only cell and gene therapy CDMO that has brought its own product to the market (Zalmoxis®).
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Tech Transfer & Process Development

  • Knowledge transfer from client to AGC Biologics
  • Feasibility studies for new processes with new reagents and materials
  • Transfer of client process at different development stages from R&D scale to cGMP grade
  • Optimization studies to improve process performance
  • Verification studies to validate the production process
  • Comparability studies
  • Analytical development for potency and client specific assays
  • Qualification of analytical methods before transfer into QC
  • Implementation and optimization of automated assays
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In-House Analytical Methods Development

Drug Substance
  • Potency: Viability
  • Safety: Mycoplasma PCR
  • Identity: Immunophenotype
Drug Product
  • Potency
    • Transgene functional assay
    • Viability
    • Immunophenotype
Safety
  • Endotoxin
  • RCL Molecular assay
  • Microbiological control of cell suspension
Identity
  • Vector identity/integrity
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cGMP Manufacturing & Quality Control

  • Release, IPC, characterization and stability testing
  • Analytical method transfer
  • Method validation in accordance with relevant guidelines
  • Stability studies management (scheduling, testing, documentation and statistical analysis to support shelf life definition)
  • Characterization studies management
  • Outsourcing testing management
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Quality Assurance

  • Raw materials release
  • Support with regards to regulatory submissions (IND, IMPD, BLA, MAA)
  • Integrated quality systems incorporating US, European, and ICH cGMP requirements
  • Comprehensive Quality Agreements
  • Regulatory compliance and validation expertise
  • History of successful client audits and regulatory inspections
  • EU cGMP Certification
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