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While the drug development team is in the process of working on the last details to optimize the drug, that is where the work for the packaging engineers really starts. A cumbersome journey of scouting and evaluation of all possible packaging options out there, followed by extensive testing and complex interpretation of the results. This process can take many months without assurance of comprehensively addressing all factors. Especially in the space of prefilled syringes which are regulated as combination products, the requirements are expansive and often ambiguous. This presentation introduces a groundbreaking innovation: An advancement in the prefillable syringe market, uniquely integrating the syringe barrel, plunger, and needle shield/tip cap into a fully harmonized, verified system from a single supplier. It will demonstrate how this system enables especially emerging biotechnology companies to significantly save time and resources, accelerating the pathway to clinical fill.
A: West rubber formulations 4023/50G and 4432/50G are used in plungers available with the West Synchrony S1 PFS system.
A: There are 5 different formats currently offered in the West Synchrony S1 PFS system portfolio. System options include the following syringe barrel formats:
Please visit West Synchrony™: Prefillable Syringe System for the full product portfolio.
A: SBAs come in either a 10x10 or 10x16 (depending on selected configuration) nested tub.
A: West Synchrony is offered as a system, with the syringe barrel, needle, needle shield/tip cap and plunger designed and verified as a true system. As such, components that are part of the West Synchrony offering can only be ordered and delivered to the customer as a complete system and not purchased separately.
A: Polymer-based syringes are not part of the West Synchrony S1 PFS system portfolio. Syringe barrels are SCHOTT Borosilicate Glass Type I.
A: Absolutely. The 1 ml long staked needle system option has been tested for compatibility with autoinjectors on the market. Please inquire about our Scouting Data Package to see characterization data.
A: The West Synchrony S1 PFS system has successfully ran at multiple CDMOs in the US and Europe across various fill/finish platforms. Please contact West to learn more about our CDMO collaborations.
A: West does not offer a needle safety device. However, the West Synchrony S1 PFS system has been tested for compatibility with needle safety devices in the industry. Please inquire about the Scouting Data Package for characterization data.
A: Container Closure Integrity testing has been performed as part of our Design Verification approach. Please get in contact with your account manager to learn more.
A: Leachables can only be tested with the actual drug product. Extractables have been evaluated as part of our biocompatibility assessment, which is provided in the Verification Data Package. Please get in contact with your account manager to learn more.
A: We have comparison data for break-loose and glide forces for the different West Synchrony S1 PFS system configurations as part of the Verification Data Package. This was done with water for injection. We are working on generating data for different viscosities. This will be shared once it is available.
A: Yes. Please contact West to learn more about our Verification Data Package included with the system.
A: This is strongly individual and drug-dependent. However, West has suggestions for a gap assessment and the corresponding bridging studies. Please get in contact with your account manager to learn more.
A: Within the West Synchrony S1 PFS system offering, sprayed silicone oil is used to coat all syringe barrels.
A: Water for injection for 1 cP and a glycerol solution for higher viscosities have been used.
A: The shelf life of the West Synchrony S1 PFS system is for the unfilled PFS system only. Shelf life of the combination product should be determined based on the drug profile during stability studies.
A: That is correct, although we offer unlaminated plunger options for the system as well. We are aware of the concerns around the use of PFAS in pharmaceutical films and coatings, and we have had internal discussions about market needs for the future.
A: We have different levels for cosmetic defects. Please get in contact with your account manager to learn more.
A: All content related to West Synchrony S1 PFS system can be found at West Synchrony™: Prefillable Syringe System
Interested in learning more? Click here to contact us and speak with one our experts or click here to watch our on-demand webinar.
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