More Than 86000 sqft GMP Facility
One-stop Shop CDMO Solutions

CRO service

GMP Plasmid DNA Manufacturing Platform

  • Production Capacity: 2 GMP Plasmid DNA production Lines
  • Comprehensive QC and Analytical Services
  • Production Scale: 5L-200L

GMP AAV Manufacturing Platform

  • Production Capacity: 4 GMP AAV production lines
  • Production Scale: 25L-500L
  • Production Yield: up to 10^17 vg/batch
  • Production Platform: Adherent / Suspension
CRO service
CRO service

Analytical Development & QC Platform

  • Analytical Development: Based on project-specific methodologies
  • Established 40+ Analytical Testing Methods including TCID50, rcAAV and AUC
  • Analytical Verification and Validation: Risk-Based and Phase Appropriate
  • Batch Release and In-process Testing
  • Stability Studies

Quality Assurance

  • Single-use Technology
  • Compliant with NMPA/FDA/EMA regulations
  • Unidirectional Flow, Physical segregation System
  • Phase Appropriate Compliance solution
CRO service

Process Development Capabilities

QbD Process Optimization with a total PD+AD lab of 5000+ sqft

Process Development Services

  • Cell line development, adaptation and cell banking (GMP)
  • Medium screening and cell culture optimization
  • Upstream bioreactor process optimization
  • Harvest process optimization
  • Purification process optimization
  • Scalability assessment
  • Improved target product profile
  • Facility fit and technology transfer to GMP manufacturing
Current PD Capabilities

  • iCells nano bioreactors
  • Wave bioreactors: 5L, 25L
  • Sartorius amber 250 high throughput bioreactors system
  • Applikon 3L, 15L
  • AKTA Avant, AKTA pure
  • Solution prep up to 200L
In-House Analytical Capabilities

Full panel analytical capability serving AAV and DNA plasmid release and product characterization; 40+ analytical methods established and qualified.

Category Test Method
Identity AAV Capsid SDS PAGE/HPLC-MS
Purity Protein Purity SDS PAGE/HPLC
UV Purity A260/A280
Empty capsids AEX HPLC
AUC
Potency Capsid Titer ELISA
Genome Titer ddPCR
Infectious Titer TCID50
In Vitro Bioactivity Cell-based assay
Impurity Residual hcDNA qPCR, ddPCR
hcDNA size distribution CE/ddPCR
Residual E1A ddPCR
Residual HCP ELISA
Residual BSA ELISA
Residual Plasmid ddPCR
Residual Nuclease ELISA
Residual Iodixanol HPLC
Residual Ligand ELISA
Safety Mycoplasma qPCR
rcAAV Cell Assay+qPCR
Bacterial endotoxin LAL
Sterility Direct Inoculation Method/Membrane filtration
Adventitious agent Cell Culture
General Characterization Appearance Visual Inspection
Filling Volume Minimum Filling Volume
pH pH Method
Osmolarity Osmometers
Particulate matter Light Obscuration Particle Count test
Aggregation Dynamic Light Scattering
Poloxamer 188 Content HPLC
AAV Neutralizing antibody ELISA / Cell-based assay

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As the world leader in AAV vector packaging services and AAV production, PackGene provides the quality CRO and CDMO services you need to translate your gene therapy from discovery to clinical research and commercial manufacturing. Please reach out to us with any questions and a member of our highly trained technical expert team will get in touch with you as soon as possible.

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