W. L. Gore & Associates, Inc.—more commonly known as Gore—has launched a new syringe plunger within its PharmBIO business: the 0.5 mL silicone-free GORE IMPROJECT Syringe Plunger.
First, tell me about Gore.
Contrary to its more legal-sounding name, Gore is a global materials science company launched in 1958 with a presence spanning across five continents.
Its inventory of products extends to industries such as aerospace, environmental protection, technology and telecommunications, and life sciences—to name just a few.
- And in the life sciences space, its products include the medical as well as pharmaceutical and biopharmaceutical industries.
And before we get to this product, explain the role of PFS in ophthalmology.
There are typically two options for administering drugs—such as anti-vascular endothelial growth factor (VEGF)—into the eye for treatments of retinal diseases, like diabetic macular edema (DME), diabetic retinopathy (DR), and retinal vein occlusion (RVO).
- Those options: A PFS or single-use vial.
The process for each differs, with fewer steps required for a PFS versus vial.
- For a PFS: The drug is injected directly from the PFS into the eye
- For a vial: The drug must first be taken from the vial, via a needle and syringe, before it can be injected
Gotcha. And what other benefits come with PFS?
A few other advantages for clinicians delivering IVT injections:
- Simplified preparation and administration process for improved efficiency
- In fact, recent research found that clinicians spent about 50% less time getting ready for injections when PFS were utilized over vials
- Increased safety and decreased risk of endophthalmitis (versus single-use vials)
- In other words: A lower rate of infection inside the eye
Alrighty, now introduce this new product.
The GORE IMPROJECT Syringe Plunger is specifically intended for prefilled syringes (PFS) utilized in such applications as ophthalmic intravitreal (IVT) injections.
Important to note: Silicone is completely removed from both the plunger and barrel in its PFS.
- Why this silicone-free component is key: Silicone—which typically acts as a lubricant to create a seal between the plunger and barrel—is known to cause such complications as ocular inflammation, protein aggregation, and intraocular pressure (IOP) increase.
Explain more about its design.
The syringe plunger contains a polytetrafluoroethylene (PTFE)-based fluoropolymer barrier with a bare-glass (non-silconized) syringe barrel.
What makes it unique: By combining with a silicone-free glass and advanced polymer syringe barrel, the plunger reduces the “risk associated with silicone by enabling its removal from the syringe," according to a company representative.
- Check out its validation guide
And this unique component leads to …
Among its capabilities, the plunger:
- Can be terminally sterilized
- Maintains consistent drug delivery time (as evidenced in in 2-year and accelerated aging tests)
- Allows for syringe systems to reach particulate levels below the limits of United States Pharmacopeia (USP) <789> subvisible particle standard in testing
- This standard level is only for testing performed on ophthalmic solutions
- Provides suitable “break loose and glide force (BL/GF)” when used in combination with certain syringe components and commercial fill and finish processes
- BL/GF refresh: This refers to the amount of force required to move a syringe plunger
- Has demonstrated highly effective container closure integrity (CCI) performance
- CCI refresh: This is the ability of a container closure system to maintain quality and sterility of a products throughout its shelf life
Nice! Now, this isn’t the first Gore plunger to be released, correct?
That’s correct.
In fact, the silicone-free syringe plunger is also a complement to Gore’s previously-launched GORE IMPROJECT 1 mLL plunger, which hit the U.S. commercial market in 2018.
- About that plunger: As with this latest addition, the 1 mLL plunger’s design is geared toward eliminating the need for silicone as a lubricant in PFS and the glass barrel
Gotcha. So what’s the end-game purpose behind these plungers?
To reiterate Gore’s message: The company seeks to enable clinicians to perform “more challenging ophthalmic injections” without the need to involve silicone of any form—extending to:
- Silicone oil
- Cross-linked silicone
- Resin-enhanced silicone
“We involved key partners to ensure the product meets the needs of stakeholders throughout the value chain including rigorous fill & finish requirements,” stated Russ Hornug, Gore’s business development manager.
- And as the company noted: With increasing needs for precise, low-volume injections in ophthalmology, gene therapy, and pediatric care, Gore’s 0.5 mL prefilled syringe plunger offers a new alternative.”
Lastly, where can I find these silicone-free plungers?
Contact the company to request a product order.