Self-Injection Made Easy
3mL cartridges are proven delivery devices for small-molecule and biologic injectables. Pii’s 3mL cartridge is compatible with devices aimed at improving patient compliance by supporting a range of therapies that require frequent injections and variable dosing.
READY-TO-USE (SINGLE-USE AND MULTI-DOSE) 3ML CARTRIDGE IS IDEAL FOR HIGH VISCOSITY, COMPLEX INJECTABLES, CONTROLLED NARCOTICS, DEA SUBSTANCES, AND PRODUCTS THAT REQUIRE EXTREMELY ACCURATE DOSING.
The combination of an aging population and more people suffering from chronic diseases is making it difficult for healthcare professionals to effectively treat patients over the long term, subsequently impacting patient compliance. This has led to increased demand for patient-friendly administration systems, such as single-chamber cartridges. In fact, industry gurus estimate the global autoinjector market, which includes cartridge-based systems, to be valued at more than $6.2 billion by 2027.1
Improving Dosing Options
The ready-to-use (RTU) 3mL cartridge-based -- single-use and multi-use -- is specifically designed to ensure consistency of delivery for high-viscosity, high concentration injectable drug delivery systems.
According to the National Center for Biotechnology Information, subcutaneous (SC) delivery of biologics has traditionally been limited to fluid volumes of less than 1mL, with recent increases to volumes of about 3mL. This injection volume limitation poses challenges for high-dose biologics as these formulations may also require increased solution concentration. This may result in high viscosities that can affect the stability, manufacturability, and delivery/administration of therapeutic drugs.
Currently, there are technologies that can help to overcome these challenges and facilitate the delivery of larger amounts of drug through the SC route. This can be achieved either by enabling biologic molecules to be formulated or delivered as high-concentration injectables (>100mg/mL for antibodies) or through facilitating the delivery of larger volumes of fluid (>3 mL).2
When compared to plastic, glass is a much better container for drugs that must be held for longer periods of time or are meant for multi-dose use. Overall drug stability is improved with glass, and ease of pharmacy preparation for the patient equates to compliance and safety.
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3mL Cartridge Tub & Nested Carrier
An RTU cartridge-handling system offers tight tolerances, precise dimensions, and premium surface quality. Cartridges are delivered pre-sterilized and are filled aseptically from nests under stringent quality controls to ensure sterility.
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3mL Cartridge Kit Assembly
The 3mL cartridge offers ease of use, optimized design, multi-dose flexibility and injection reliability making it ideally suited to the shift toward self-injection. Designed for a variety of therapies that require frequent injections and/or variable dosing, the 3mL cartridge accommodates a range of patient profiles for disease management.
Pii can support packaging of a variety of kits, including our 3mL filled cartridges.
The RTU 3mL cartridge kit includes:
- A 3mL drug cartridge (fill/finish at Pii)
- Pre-packaged and sterilized needles
- Injection device
Pii will aseptically produce your filled cartridge and even support packaging of the final kits, which can then be supplied to clinic or market.
3mL Cartridge Robotic Aseptic Fill-Finish Production
The state-of-the-art GeniSYS®R20 supports smaller batch sizes to aseptically and accurately fill 3mL glass cartridges. The innovative GeniSYS®R20 filler enables non-destructive in-process weight checks to minimize stoppages and losses during production. Pii will deliver sterile clinical and commercial supplies with very aggressive timelines, getting you to your clinical study on time and on budget.
Pii’s full-service development and manufacturing teams can assist you with your project using our Concept-to-Clinic-to-Commercialization Pharmaceutics Know-How™.
- Sterile Injectables Device and Packaging Trends, by James Grote, Pharma’s Almanac, Nice Insight, March 14, 2022.
- Subcutaneous Delivery of High-Dose/Volume Biologics: Current Status and Prospect for Future Advancements, Advait V. Badkar, et. al., Jan. 13, 2021.
- Global $7.46 Bn Pharmaceutical Glass Packaging (Vials, Bottles, Cartridges & Syringes, Ampoules) Markets to 2028, ResearchandMarkets.com, Sept. 24, 2021.
