West Pharmaceutical Services unveiled the Synchrony S1 prefillable syringe system to streamline drug development for biotechs, reducing regulatory complexity with a single vendor. The system is manufactured in Ireland with 200+ configurations, ETO sterilization, and a two-year shelf life. West offers four free document packages to simplify the process for developers. Dr. Bettina Boltres highlighted the challenges faced by development teams in the pharmaceutical industry, emphasizing the need for a faster and more efficient approach to drug packaging development. She discussed the increasing pressure on teams due to long development timelines, complex regulations, and supply chain challenges. Boltres also noted the high costs and reduced market exclusivity resulting from delays in bringing a medicinal product to market. The time from patent to launch has shortened in recent years, with an average of 10.6 years for larger pharmaceutical companies. Delays can lead to significant revenue losses per day in high-value therapeutic areas. Boltres discussed how syringes are now regulated as combination products, requiring a shift in the evaluation process for drug packaging and device constituent parts. This change brings additional requirements and complexity, particularly in Europe. She highlighted the need for compliance with new ISO standards for elastomers and glass containers, as well as final-system performance standards. Boltres emphasized the importance of a system-level approach to reduce complexity in assembling prefillable syringe systems, allowing for a single data point per attribute in the system. She pointed out the challenges of reconciling component specifications from multiple suppliers due to differences in formats and units. Boltres discussed the practical hurdles faced by development teams, such as varying lead times and minimum order quantities, as well as the complexities of assembling regulatory documentation from multiple sources for submissions. In two audience polls, respondents identified regulations, device development resources, and supply chain as significant pressures in the development process. The majority of respondents recognized the challenges described in sourcing and qualifying prefillable syringe components. West presented the Synchrony S1 PFS system as an integrated solution supplied as a complete set by a single verified supplier. The system includes a glass syringe barrel, plunger, needle shield tip or cap, and is designed to address challenges in designing, regulating, and managing the supply chain for syringe systems. Boltres discussed the document packages provided by West to support customers in the development process, including scouting information, verification data, and regulatory documentation. The packages are intended to assist customers from early evaluation through submission. West’s manufacturing and system release process is based in Waterford, Ireland, where representative parts are assembled and tested against system specifications before shipment. The company offers more than 200 validated systems for biologics and vaccine applications in various sizes and configurations. West also described two “Signature” make-to-stock systems available for order, with different configurations and quantities. Boltres explained that the Synchrony S1 system is ETO sterilized and uses SCHOTT FIOLAX Type I glass compliant with industry standards. She highlighted the system’s two-year shelf life and ongoing exploration of sustainability considerations for future developments. The article highlights West Pharmaceutical Services, Inc., a global developer and manufacturer of components, systems, and services for injectable drug packaging and delivery. The company focuses on high-quality solutions for the pharmaceutical and biotech industries, offering primary drug packaging components and specialized delivery devices. West is known for its elastomeric closures and polymer components that maintain sterility and drug compatibility. Additionally, West provides engineered delivery systems and support services across the product lifecycle. The unveiling of the Synchrony S1 syringe system by West Pharmaceutical Services aims to expedite drug packaging development and simplify the process for drug developers, particularly emerging biotechs. The system offers an integrated and verified syringe set supplied by a single vendor, reducing complexity and shortening timelines. West provides free document packages to support customers through the development process, offering detailed information and specifications. Boltres emphasized the need for a more streamlined approach to prefillable syringe packaging development to address the challenges faced by development teams in the pharmaceutical industry. She highlighted the time and cost pressures, as well as the increasing complexity of regulatory requirements for syringes as combination products. Boltres stressed the importance of compliance with evolving standards and performance requirements in the industry. West’s Synchrony S1 system is designed to address these challenges by providing a comprehensive and validated syringe set from a single supplier, simplifying the development process and ensuring regulatory compliance. The system is manufactured in Ireland with a range of configurations, sterilization options, and shelf life specifications. West’s approach aims to streamline the process for drug developers, offering a complete solution for prefillable syringe packaging. Boltres discussed the challenges faced by development teams in the pharmaceutical industry, highlighting the need for a more efficient and effective approach to drug packaging development. She emphasized the impact of long development timelines, complex regulations, and supply chain challenges on the industry. Boltres also pointed out the high costs and reduced market exclusivity resulting from delays in bringing a medicinal product to market. The time from patent to launch has shortened in recent years, with an average of 10.6 years for larger pharmaceutical companies. Delays can lead to significant revenue losses per day in high-value therapeutic areas. Boltres discussed how syringes are now regulated as combination products, requiring a shift in the evaluation process for drug packaging and device constituent parts. This change brings additional requirements and complexity, particularly in Europe. She highlighted the need for compliance with new ISO standards for elastomers and glass containers, as well as final-system performance standards. Boltres emphasized the importance of a system-level approach to reduce complexity in assembling prefillable syringe systems, allowing for a single data point per attribute in the system. She pointed out the challenges of reconciling component specifications from multiple suppliers due to differences in formats and units. Boltres discussed the practical hurdles faced by development teams, such as varying lead times and minimum order quantities, as well as the complexities of assembling regulatory documentation from multiple sources for submissions. In two audience polls, respondents identified regulations, device development resources, and supply chain as significant pressures in the development process. The majority of respondents recognized the challenges described in sourcing and qualifying prefillable syringe components. West presented the Synchrony S1 PFS system as an integrated solution supplied as a complete set by a single verified supplier. The system includes a glass syringe barrel, plunger, needle shield tip or cap, and is designed to address challenges in designing, regulating, and managing the supply chain for syringe systems. Boltres discussed the document packages provided by West to support customers in the development process, including scouting information, verification data, and regulatory documentation. The packages are intended to assist customers from early evaluation through submission. West’s manufacturing and system release process is based in Waterford, Ireland, where representative parts are assembled and tested against system specifications before shipment. The company offers more than 200 validated systems for biologics and vaccine applications in various sizes and configurations. West also described two “Signature” make-to-stock systems available for order, with different configurations and quantities. Boltres explained that the Synchrony S1 system is ETO sterilized and uses SCHOTT FIOLAX Type I glass compliant with industry standards. She highlighted the system’s two-year shelf life and ongoing exploration of sustainability considerations for future developments. The article highlights West Pharmaceutical Services, Inc., a global developer and manufacturer of components, systems, and services for injectable drug packaging and delivery. The company focuses on high-quality solutions for the pharmaceutical and biotech industries, offering primary drug packaging components and specialized delivery devices. West is known for its elastomeric closures and polymer components that maintain sterility and drug compatibility. Additionally, West provides engineered delivery systems and support services across the product lifecycle.

Read more at Yahoo Finance: West Pharmaceutical Services Unveils “Synchrony S1” Syringe System to Speed Drug Packaging Development