Packaging

The FDA has approved over twenty (20) cell and gene therapy drugs, and with the rapid growth of the cell and gene therapy market, there is greater demand than ever to demonstrate container-closure integrity (CCI) at ultra-low temperatures. To preserve the product’s efficacy, most cell and gene therapy drugs are stored at temperatures below -60ºC. Many of these products are packaged in either vial systems or cryogenic freezing bags. While each of these container-closure systems poses a unique challenge for the evaluation of CCI at ultra-low temperatures, the discussion in this blog focuses specifically on vial systems.

Liquid injectable drugs can be contained in a pre-filled syringe system, a cartridge-based system, or a vial-based system (with a rubber stopper and seal). For a vial-based system, the drugs first are aseptically filled into glass or polymer vials. During the subsequent Fill & Finish operations, the vials are closed temporarily by inserting a rubber stopper into the vial orifice. This is prior to crimping with an aluminum seal, which results in the final integral vial-based container closure system.

One of the increasing trends in the world of drug-device combination products is the use of platforms for drug families, delivery device technologies, and primary packaging.

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Innovation in manufacturing involves a spectrum of evolution improvements resulting in what West’s partner Daikyo Seiko, Ltd. considers "Absolute Quality." Recent continuous improvement efforts helped Daikyo achieve even higher levels in cleanliness of elastomer products.

Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.