Oncology

Healthcare providers, medical device, component and pharmaceutical manufacturers, as well as leading governmental and regulatory agencies, have long recognized the issues healthcare workers face with compounding and administering hazardous drugs, including oncology drugs. These industry leaders have convened to establish policy, increase awareness, and develop specific devices to protect healthcare personnel during occupational handling of hazardous drugs. In December 2019, USP <800> was enacted specifying that CSTDs “should be used when compounding hazardous drugs” and “must be used when administering antineoplastic” drugs when the dosage form allows¹. The development of these regulations and the emphasis on using the appropriate safety devices, such as CSTDs, establish a perspective that the safety of both patients and healthcare workers is significant.

However, various users have revealed a range of potential problems between CSTDs and container closure systems that include device-related issues, such as fluid leakage and broken components to chemical incompatibilities with the devices on the market². These issues elucidate the importance of choosing the most appropriate CSTD to provide physicochemical compatibility with a drug product and ultimately the best protection to the healthcare worker. Additionally, the lack of standard and harmonized performance requirements to demonstrate compatibility between a CSTD and a drug container closure system further complicates the issue. In response, working groups like Product Quality Research Institute (PQRI) are developing test standards and guidance for evaluating the inter-connectability between the vial and transfer device³.

Our expert team of dedicated scientists in West’s Analytical Services and Scientific Insights Labs have partnered with several organizations to establish multiple CSTD test capabilities and methods to investigate the issues with the container closure component or interfaces with the CSTD. Capabilities include the following:

West is “By Your Side” as you navigate the challenges of assessing a CSTD with your drug product container closure system. Please visit our Analytical Labs page to learn more about our expertise and testing capabilities.

Reference:

1. USP [2016]. USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Setting. Rockville, MD: United States Pharmacopoeia, accessed USP [2016].
2. FDA Manufacturer and User Facility Device Experience (MAUDE) Database, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm, accessed 12Oct2020
3. Cathy Zhao and Allison Radwick; 5 Challenges of Closed System Transfer Devices Parental Drug Association letter, Manufacturing Science 07Jan, 2020

Patient Focused Drug Development is a regulatory (FDA) strategy to embed the patient needs deeper into the drug development process. Why have your patient connected to a pole in an infusion chair to receive their cancer treatment when you can offer them a choice of home administration or being disconnected in the clinic?

West’s SmartDose® 10 wearable injector has demonstrated performance and is a patient-focused option for injecting large volumes in a patient friendly manner. There is a demonstrated path to market as the SmartDose platform includes the only large-volume (>1mL) wearable injector approved in combination with an approved drug.

Oncologics can make demanding needs of their packaging as they can be silicone sensitive or cytotoxic. The incorporation of West stoppers and/or plungers coated with FluroTec® barrier film into oncologic drug packaging has shown a reduction in the likelihood of chemical interactions. NovaPure® stoppers and plungers are West’s highest quality offering to help mitigate risk. Our NovaPure components include FluroTec barrier coating as a standard feature that is coupled with an enhanced particulate specification, protecting your valuable drug product.

The use of biomarkers to target patients who are most likely to respond to cancer treatment is an increasing trend and often goes hand-in-hand with fast track approval and orphan designation. The Fast Track environment further emphasizes the importance of selecting the right packaging components early in the drug development cycle. For example, checkpoint inhibitors have had first authorization after Phase II or as early as Phase I.¹

When choosing your primary packaging/container system, Daikyo Crystal Zenith^® vials, prefilled syringes and cartridges for wearable injectors support all stages of your drug’s lifecycle. Crystal Zenith^® vials, which are currently used to package a commercial oncology drug, offer you a reliable commercialized container with demonstrated high performance and low breakage and interaction risk, which is available in ready-to-use, small quantities. West also offers vials, seals and stoppers in our Ready Pack^™ system, which can be ordered online, with a favorable extractables and profile. All options are scalable to large quantities without material changes and additional drug product evaluations.

Pharmaceutical pipelines are well-populated, and the greatest focus of all therapy areas is oncology with approximately 900 molecules in Phase I-III.² However, those molecules will need to be brought to market in varying packaging and delivery formats based on the needs of the molecule, the patients and the delivery requirements. With more than 70 oncology products expected to launch in the next five years², it is imperative to minimize risk in your packaging, analytical and regulatory choices early in development to help accelerate your path to market.

West understands the challenges you face along the drug development journey. We’ve supported customers with their drug development projects for more than 95 years. West offers integrated solution packages for Prescreen and Compatibility, Clinical Phases I-III and Lifecycle Management across all injectable formats. Tailored to the unique needs of your oncologic, West can Simplify the Journey^™ from molecule to patient by helping you:

• Reduce development and supply risk
• Accelerate your path to market
• Minimize total cost of ownership
• Improve the patient experience

West’s Integrated Solutions program guides you through the ever-changing regulatory and analytical testing requirements for primary packaging, combination products and delivery systems.