Differentiate with a unique delivery or administration system
Packaging can be a significant factor in the success of a drug product getting through the regulatory approval process smoothly
and to the market quickly. How the product is going to be delivered should be determined based on the clinical application,
but research and development is not the time to try a new or high-risk packaging material or system.
Pharmaceutical manufacturers should initially seek out reliable, low-risk packaging materials that are standardized and then
apply a unique delivery system to differentiate and optimize delivery. Ideally, the same package should be used for containment
from drug research through to commercialization phases.
In many cases, the goal is to move from a vial/stopper system to a prefillable syringe system or auto-injector. Selecting
a material that can be used consistently throughout the drug development process, such as a cyclic olefin polymer, can help
mitigate risk and reduce time to market. Since this material is plastic, it can be molded into a variety of shapes and sizes,
enabling manufacturers to offer unique delivery or administration systems without the need to retest the material for interactions
with the drug product.
Having the same material involved in bulk storage, vials, and delivery or administration systems provides consistency in the
drug-material interface and minimizes contamination risk as the drug moves from research to clinical trials to commercialization.
Maintain focus on core business
Partnering with a component manufacturer can help drug companies maintain focus on their core business by eliminating the
extra time, money, and staff associated with component preparation and sterilization.
For pharmaceutical manufacturers, eliminating the in-house component preparation process can be a cost-effective method of
complying with new regulations and streamlining the fill process. By creating a lasting partnership with a packaging manufacturer,
drug makers not only help to establish compliance and improve quality, but also have the ability to rely on expert advice
and counsel throughout a drug's life cycle.
Containers and administration devices are integral to the safety and efficacy of drug therapies; consequently, the alignment
of packaging manufacturers with drug development and production processes will enhance quality, and ultimately, patient safety.
Fran L. DeGrazio is vice-president of marketing and strategic business development at West Pharmaceutical Services, 101 Gordon Dr., Lionville,
PA 19341, tel. 610.594.2900, fax 610.594.3000, Fran.Degrazio@westpharma.com
|
