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Packaging and Delivery: Early Selection Can Ease Development

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Pharmaceutical manufacturers are challenged to produce high quality products that meet or exceed regulatory requirements while effectively executing a profitable business model. Often considered an afterthought, packaging and delivery systems can affect the safety, efficacy and commercial success of drug products.

Selecting the right packaging and/or delivery system early in the development process can provide economic value for drug manufacturers. Cost savings can be realized when those same packaging materials can be used throughout the drug product’s lifecycle – from early development through commercialization.

An appropriate container closure system can help to mitigate risk in the early stages of development, when the drug product may be in short supply and overfill costly. Selecting a container closure system that provides components in an easy, ready-to-use format can reduce worry that the system may negatively affect the drug product further down the line.

The Ready Pack® system is a convenient, sterile, ready-to-use packaging system that provides components for small-quantity filling while meeting requirements from research and development through commercialization. The Ready Pack system consists of sterile vials, stoppers, seals and vial adapters, which are delivered ready-to-use and have a track record of successful commercial applications. Because the components are sterile, manufacturers can eliminate this component preparation step from their processes, saving time and money.

Since the components of the Ready Pack system are also available in commercial quantities, they can be used throughout the drug product’s lifecycle, helping to reduce or eliminate testing of additional container closure or delivery systems.

Depending on a drug product’s properties, manufacturers can select vials made from glass or Daikyo Crystal Zenith® cyclic olefin polymer. The Crystal Zenith polymer is ideally suited for packaging high-value biopharmaceuticals or those requiring low-temperature storage or shipping, and can help minimize problems associated with extractables, silicone oil, and glass vial breakage and delamination.

Vial adapters can help to reduce overfill early in the development process by providing a reproducible engineered depth for drug aspirations, which may reduce the end-user variability associated with traditional needle aspirations. Manufacturers are then able to expand drug supply and decrease costly overfill.

For more information about the Ready Pack system or other packaging and delivery solutions for your drug product, contact your account manager.

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