Fran DeGrazio

VP, Scientific Affairs & Technical Services

May 18, 2012

Lifecycle Planning

It can take more than 12 years and a major financial investment to bring a drug product to market.¹ A drug product’s success relies on its efficacy, safety and manufacturing efficiencies along with the use of innovative strategies to meet evolving market needs and reinforcement of patient adherence. The importance of container closure and delivery systems as critical to success in the pharmaceutical industry is becoming more visible especially in respect to pharmaceutical and biotech organizations that desire to proactively minimize their risks.

Qualified container closure systems are necessary throughout a drug product’s lifecycle, spanning from pharmaceutical development through product discontinuation. Planning for the appropriate choice of container closure materials that can be viable during the different stages of the drug product lifecycle should consider several major factors that includes:

· mechanical strength of the packaging material

· protection of the drug product

· potential for contamination of the drug product

· stability of the packaging material

· visual appearance, characterized as pharmaceutical elegance

· type and impact of sterilization

· compatibility with the drug product and the other packaging components and delivery systems

· supply chain security

· meeting ever-increasing regulatory compliance demands

These elements should be evaluated appropriately and proportionally to each lifecycle stage, recognizing opportunities to identify areas for improvement.

In initial stages of drug development, vials and closures are typically used but with certain categories of drugs, such as vaccines or human growth hormones the overall strategy may include administration with prefillable syringes. Some therapeutic categories such as treatments for rheumatoid arthritis (RA) incorporate additional delivery systems such as auto-injectors to help the end patient comply with treatment dosing.

As many biopharmacetuicals in development are higher in viscosity and dosing may need to be above what can be supplied in a traditional 1mL long syringe, opportunities for delivery through other systems becomes desirable. In these cases it is desirable to have the ability to form the same primary container materials that may have been used for the vial or prefilled syringe into different sizes and shapes suitable for advanced delivery systems. For instance, high -performance cyclic olefin polymers such as the Daikyo Crystal Zenith^® polymer can be custom molded and may be especially compatible with biopharmaceuticals. This is strong, stable material that can be subjected to sub-zero temperatures, is break resistant, can be e-beam sterilized and has relatively few constituents. As a result, there is a lower potential to interact with a drug product.

Limiting the number of primary materials that will be in contact with the drug product over its entire lifecycle leads to economic benefits in the long-term. A pharmaceutical company can gain a competitive advantage by planning in advance for a self-administration system even in the earliest stages of development. Self-injection systems can result in overall cost savings, so an efficient and effective delivery system can facilitate patient adherence and have tremendous economic value.

Collaboration between pharmaceutical manufacturers and packaging and delivery system suppliers can enable performance goals to be met efficiently while better managing operating costs. A strong relationship can provide the necessary support for appropriate selection of materials during development, day-to-day support when in commercialization and for solving challenging problems as they arise, assuring continual supply of product.

References:

¹Joseph A. DiMasi, Ronald W. Hansen, and Henry G. Grabowski, “The Price of Innovation: New Estimates of Drug Development Costs,” Journal of Health Economics, vol. 22, no. 2 (March 2003), pp. 151-185.

Daikyo Crystal Zenith^® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith^® technology is licensed from Daikyo Seiko, Ltd.

Categories:

Components Self-Injection Platforms Early Partnerships

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