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The author describes key considerations for drug manufacturers when evaluating packaging partners.
Bringing a new pharmaceutical product to market can be an exciting and often difficult time for manufacturers, and packaging considerations are not often top of mind in the early stages of the development process. Early guidance from experts with experience in packaging applications and manufacturing practices can help manufacturers augment their production processes by identifying potential hazards associated with packaging materials early in development. By working together, drug and packaging manufacturers can develop a customized solution that reduces the risk of container-closure failure.
Such a partnership can help mitigate risk, increase efficiencies, and ensure sustainability while improving products and processes. By redefining traditional production roles, choosing consistent components and high-quality materials, differentiating between drug product with a unique delivery or administration system, and focusing on core competencies, pharmaceutical companies can deliver a safe, effective product that will stand out in the marketplace.
Redefining roles—early partnerships reduce risk
Enhanced regulations and regulatory guidance on current good manufacturing practices, as well as the trend toward biopharmaceuticals, have all impacted drug-product manufacturing. Amendments to the Food and Drug Administration regulations for finished pharmaceuticals (21 CFR 210 and 211) require more stringent compliance concerning the preparation of components for sterile drug products. Those requirements include the need for each lot of a drug product's container/closure system components susceptible to contamination to undergo microbiological testing (i.e., bioburden and endotoxin) before the products are used, as well as validation for all aseptic and sterilization processes. By partnering with a packaging manufacturer, pharmaceutical companies can improve manufacturing technologies, which in turn creates more sophisticated, high-quality container-closure and drug-delivery systems.
Such a partnership is a benefit to both drug and packaging manufacturers. The ability to understand each other's processes and trouble-shoot potential pitfalls will allow the packaging manufacturers to improve their products and processes to meet the needs and standards for high quality that both the drug manufacturer and the regulatory agencies seek. Early-phase partnerships enable pharmaceutical companies to build a sustainable manufacturing process that increases efficiencies while creating product that has fewer issues with contamination or rejection. There is the additional added benefit of increasing knowledge management by broadening the exchange of information past just the drug manufacturer's internal knowledge base.
Consistent components help eliminate extractables and leachables
Pharmaceutical manufacturers should look for packaging components that are consistent from lot to lot. Such components will help avoid costly issues with leachables, particularly when packaging is used consistently throughout the life cycle of the drug product. Using the same packaging materials from research and development to commercialization helps manufacturers determine the possibility of interaction between the drug and its packaging early in the process. Interactions can lead to issues, such as glass delamination and leachables, which can affect patient safety.
Components can be certified on a lot-to-lot basis for extractables and may include an extractables profile and/or specifications. Certification helps assure that the composition of the closures, and the closure-manufacturing processes, are uniform. These high-value components, including stoppers and syringe pistons, address several industry challenges, including giving the customer the ability to move quickly into a leachables-testing program. A comprehensive technical package can be provided that expedites drug-application-specific leachables testing. It also provides verification of change control around the component itself. This is critical when the drug-development and commercialization cycle can take years to complete.
High-quality materials can help avoid costly recalls
Choice of packaging material can impact a manufacturer's bottom line now or in the future. By selecting container-closure systems made from a novel material such as a cyclic olefin polymer, companies may incur a slightly higher initial investment, but the long-term advantages can far outweigh this outlay.
Cyclic olefin polymers enable manufacturers to offer a high-quality, transparent, break-resistant material that is more inert than glass, is scratch resistant and, unlike glass, does not flake, which reduces particulate contamination within a vial or syringe system. These components also can be stored and shipped at low temperature with reduced breakage, which is a common requirement of many biologics.
Using a plastic system over an existing glass system can help pharmaceutical manufacturers prevent the following:
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