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You are under pressure to get your oncologic molecule to market as fast as possible, with minimal risk. But the way in which new drugs are developed is changing, forexample,
West understands the trends, focus and challenges from the lab to the patient, so we can help you identify where and when missteps occur and how to address them.
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.
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:
West’s Integrated Solutions program guides you through the ever-changing regulatory and analytical testing requirements for primary packaging, combination products and delivery systems.
Fill-finish Enablement Services
Many drug developers are challenged to find fill-finish options for the broad variety of drug product packaging and containment options on the market, particularly for novel formats that provide differentiation and improved patient experience but may have unique fill-finish requirements. Finding a suitable fill-finish partner can often add unexpected delays to your development timetable. Rest assured, West can help mitigate that risk and help ease the path of your oncologic’s delivery to the patient.
With West’s lab scale fill-finish capability, established 3rd party network, and expertise in fill-finish requirements for innovative containment systems such as the Daikyo Crystal Zenith® polymer technology, West is uniquely positioned to provide fill-finish support services that help Simplify the Journey™ from concept to commercialization.
Swissfillon for complex biologic fill/finish from clinical to small scale commercial
Comprehensive analytical services for filled containment : QC and release, combination product testing
Integrated program management across device and fill finish activities, to simplify the supply chain.
Cold temperature storage
There are many cell and gene therapies in the biologics pipeline which have the potential to disrupt oncology treatment. The containment of gene therapies requires a robust system designed to mitigate risks. Nucleic acids, and their delivery vehicles such as adeno-associated virus (AAV) or other viral vectors, have unique sensitivities and low temperature storage needs. Selecting the wrong package could adversely impact the drug and, more importantly, the patient.
Ensuring that your gene therapy is delivered safely and effectively is the primary goal and starts with the selection of the primary packaging components. Maximize preservation of your product by choosing packaging components with demonstrated performance in low temperature storage conditions required by gene therapies. Container systems with Daikyo Crystal Zenith® vials perform well at low temperatures and maintain Container Closure Integrity (CCI) down to the vapor phase of liquid nitrogen at approximately -180°C. West’s Ready Pack™ components, including Crystal Zenith® vials, have been selected to contain the first gene therapies approved by the FDA for sale in the U.S.
MixJect® and SmartDose® are registered trademarks of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
WEST Ready Pack™, Flip-off®, NovaPure® and FluroTec® are registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Daikyo® Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo® Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
FluroTec® technology is licensed from Daikyo Seiko, Ltd.