Prefilled Syringe (PFS) and Cartridge Filling
Combination devices that enable the transition of large-volume treatments to home care are transforming the drug-delivery landscape. Larger subcutaneous injections (e.g., 5 ml or more) have become relevant with the development of biological drugs that require higher viscosity or higher dosing. Devices necessitate adherence to specific requirements, including considerations for quality, expedited market entry, capacity, and successful commercial launch. As biologic drugs evolve, they present new requirements that call for innovative devices and primary containers capable of accommodating higher-volume fills. The transformation of CDMOs in their skill sets and equipment requirements to serve clients is evident.
As technology advances, customer and regulatory expectations elevate. It is essential to engage the right personnel and invest in modern equipment to meet current standards. Large- and small-volume production is expected to increase, with a notable rise in the number of molecules developed in smaller volumes, driven by technological advancements. The development of targeted therapies with a diverse array of molecules reflects this trend, as evidenced by recent developments in vaccines and GLP-1 medications. Large volume production will remain a significant aspect of the industry, especially for on-body devices, as its importance is undeniable. Our new syringe and cartridge filling center ensures GRAM is at the forefront of client value delivery, significantly increasing our capacity and expanding fill-finish services for emerging technologies.
Pharmaceutical companies are focusing on the patient experience and optimizing drug delivery earlier in product development than ever before. Patient-centricity underscores the growing reliance on CDMOs and their strategic partnerships as experts in their fields, further solidifying their role as essential partners in the pharmaceutical development process. By cultivating relationships with transformative, advanced, and experienced CDMOs, pharmaceutical organizations can focus on their core competency: developing new therapies and solutions for patients.
GRAM Has Two Lines That Offer Different Solutions
We aim to give our clients the ultimate versatility to scale their products and succeed in the marketplace. To do so, GRAM invested in two filling lines supporting syringes and cartridges and critical filling steps for on-body delivery devices and autoinjectors.
1. For your low to medium-volume products or custom drug delivery innovations
Bausch+Ströbel VarioSys® Syringe and Cartridge Filler with SKAN Isolator
Our modular line, the Bausch+Ströbel VarioSys with SKAN Isolator, is ideally designed for modest demand or niche products filled in syringes and cartridges. Solutions for small to medium batch sizes without compromising quality are critical, and designs such as the VarioSys allow for component flexibility and product segregation without the expense of separate filling lines.
- Syringes and cartridges in a 10 x 10 nested filling process
- Two-head peristaltic or rotary piston pumps
- Syringe change parts for 1 mL, 2.25 mL, 3 mL
- Cartridge change parts for 3 mL, 5 mL, 10 mL, 20 mL
- Modular isolator with fast and easily exchangeable filling modules allows rapid changeover from one process to another, as well as lower costs for customsized change parts.
- Compact size minimizes drug substance (DS) loss and provides maximized batch yields.
- Maintenance, cleaning, and filling module setup occur outside the isolator, thus optimizing filling line utilization.
2. For your medium to high volume ISO syringes and cartridges.
GRONINGER UFVN Syringe Filler with SKAN Isolator
Our newest line is being designed for the growing biologics market, using the latest filling technology for the tightest manufacturing controls for critical drug-device parameters. A high-speed line, the GRONINGER 10 Head UFVN Syringe Filler with SKAN Isolator supports larger batch sizes.
- Syringes and cartridges 10 x 10 nested filling process
- 10-head peristaltic or rotary piston pump filler
- Syringe change parts for 1 mL, 2.25 mL, 3 mL
- Denesting of syringes with linear movement of syringes to maximize Annex compliance (First Air principle)
- 100% IPC for weighing, stopper placement, and needle shield verification.
- Downstream renester and automatic rejects removal
- In-line automated visual inspection.
- Qualification 4Q26