Gene therapy products require specialized packaging to ensure stability, sterility, and regulatory compliance. The packaging must protect the sensitive biological materials while meeting FDA and global regulatory standards.
Key Packaging Requirements for Gene Therapy Products:
1. Primary Packaging (Direct Contact with the Product)
Vials & Syringes:
Made from glass (Type I borosilicate) or Cyclic Olefin Polymer (COP)/Cyclic Olefin Copolymer (COC) to minimize interactions.
Must be sterile and low in extractables/leachables to maintain product integrity.
RTU(ready to use) 2ml COP vial
Seals & Closures:
Rubber stoppers (e.g., butyl or fluoropolymer-coated) to prevent contamination.
Aluminum crimp seals or child-resistant closures (CRC) when required.
Prefilled Syringes/Cartridges (when applicable)
Reduce contamination risks and improve dose accuracy.
2. Secondary Packaging (Protection & Handling)
Nest & Tub Systems (for Ready-to-Use RTU vials)
Supports aseptic processing and reduces contamination risks.
Blister Packs or Trays
Provide mechanical protection against breakage during transport.
Labeling & Barcoding
Must include product information, batch numbers, and temperature storage conditions per FDA & EMA requirements.
3. Tertiary Packaging (Storage & Transport)
Cold Chain Solutions
Gene therapy products often require ultra-low (-80°C) or cryogenic (-196°C, liquid nitrogen) storage.
Insulated shippers with validated temperature control (e.g., dry ice, phase-change materials).
Tamper-Evident & Track-and-Trace Features
Ensures regulatory compliance and prevents counterfeiting.
Regulatory Considerations
FDA & EMA Compliance: Must follow USP <1207> (Container Closure Integrity Testing) and ICH Q5A (Stability of Biotechnological/Biological Products).
Sterility Assurance: Gamma or e-beam sterilization often used for primary packaging.
Good Manufacturing Practices (GMP): Required for all packaging components and processes.
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