Clinical Scale Manufacturing

Facility Equipment Capabilities

1. Hardware

• Cytiva
• Miltenyi Biotec
• Terumo BCT
• Thermo Fisher Scientific
• Other Emerging Manufacturing Platforms

2. Quality Control / Assurance

• Real-Time PCR
• Multi-mode Plate Reader
• 12 Parameters Flow Cytometer
• 50 Parameters Flow Cytometer (and more)

Manufacturing

1. Manufacturing Services

1.1 Cell Manufacturing

• Minimal Manipulation (e.g., Plasma and Red Cell Reduction, Buffy Coat Enrichment, and Cell Selection)

• More Than Minimal Manipulation (e.g., CTGT Product Manufacturing)

1.2 Cell Banking

• Master Cell Bank Generation
• Working Cell Bank Generation

1.3 Cryopreservation and Storage

2. Manufacturing Support

2.1 On-Site QC Testing Capability

• Rapid Release Test (e.g., Mycoplasma, Endotoxin, Bacteria, etc.)

• Potency Test (e.g., Cytokine Release Assay, etc.)

2.2 On-Site QA/Audit Support

2.3 Cold Chain Management

• Using Validated In-House as well as External Logistics Providers.