Applications

Low cost, fast to implement, and minimal facilities/utility requirements make the Syn-Fill™ system an ideal approach to final product filling. Don’t risk losing your batch due to a contamination and the associated delays in clinical trials that result. Without need for specialized personnel, technology transfers, shipping studies, and external partnerships; you can implement internal final product filling in ways not possible until now.

Because of the closed processing, modularity, and simplicity of use, Syn-Fill™ systems can grow with your product from pre-clinical through commercial production.

When producing curative gene therapies, large batches are the exception not the norm. Implementation of high throughput isolator-based systems may not be the right fit for these kinds of products, but manual filling comes with risks. The Syn-Fill™ system can be a better choice. The system can achieve fill sizes from 20-2,000 units per lot, improved product yield, fast processing times, and easy to use automation interface.

Cells provide a unique challenge for final product filling. Sterilization using filtration is not an option, particulates are difficult to detect, cells can settle during prolonged filling, and the length of the filling process adversely affects the product quality. Whether filling one allogeneic large batch or multiple autologous batches simultaneously, Syn-Fill™ enables safe and sterile filling with synchronous filling shortening process times, helping maintain cell viability and functionality during fill operations. The ability to fill multiple allogenic lots in parallel without the need for multiple fill suites and multiple pieces of equipment, makes the Syn-Fill™ system a home run for personalized therapeutics.

Syn-Fill™ offers a reduced facility footprint and minimal utility requirements, making it ideal for pilot plants needing flexible and cost-effective filling solutions. Syn-Fill™ systems are ideal for implementation into pilot plants and process development laboratories. The mobile systems can also be transferred to GMP production suites and utilized for pre-clinical through commercial production.

Syn-Fill™’s ability to fill multiple unique product batches in parallel without risk of cross contamination allows for high-throughput, patient-specific filling without needing multiple pieces of dedicated equipment and filling suites. Fill 20+ batches in parallel in <4 hours, freeing up operations staff to perform other activities.

The cost-effectiveness and reduced implementation time of Syn-Fill™ make it a viable option for manufacturing orphan drugs, where production volumes are typically small, and resources may be limited. Give your product the best chance of helping someone in need by utilizing a more robust, fast to implement, and lower cost system.

Syn-Fill™’s reduced facility footprint, minimal utility requirements, and simplified operation make it suitable for point-of-care manufacturing, enabling on-site production of therapeutics.

Syn-Fill™’s flexibility to fill multiple container types (syringes, vials, bags), reduced qualification/validation requirements, mobility, low utility requirements, and ability to operate in shared production areas make it an attractive solution for cradle sites, incubators, CMOs, CDMOs, and IDMOs working on production of small batch pre-clinical and clinical final production filling; where there is a need to have flexibility and offer a wide range of filling services.

The system’s accuracy reduces product losses, closed-system processing minimizes contamination, synchronous filling reduces QC sample taxes, disposable manifolds enable fast changeovers, and low facility/utility needs enables reduced time for implementation. This combination of attributes make the Syn-Fill™ an ideal solution for sterile compounding applications.

With minimal utility requirements and a reduced need for classified cleanrooms, Syn-Fill™ offers a cost-effective and robust filling solution for developing countries with limited infrastructure.

The system’s portability, minimal utility requirements, and ability to operate in non-classified environments make it ideal for rapid deployment in military or disaster relief scenarios.

Syn-Fill™’s ability to quickly implement and scale production, combined with its closed-system processing, makes it a valuable asset for pandemic preparedness, enabling rapid manufacturing of vaccines and therapeutics.

Using a closed manifold and automated operations, the system can be setup quickly with minimal risk of exposure, filled with minimal duration, and no personnel need to be adjacent to the system during filling.

Syn-Fill™’s precise filling capabilities, synchronous filling, and no-loss priming ensure minimal product waste, making it suitable for filling high-potency and high-value solutions where maximizing yield is critical.

Monoclonal Antibody product filling can be complicated by high viscosities and sensitivity (shear, temperature, light, foaming). The Syn-Fill™ system mitigates these factors by performing a gentle filling operation using positive displacement that by virtue of its design is low shear and amenable to high viscosity liquids, ability to operate in cold rooms, short process times (<2hr with light protection), and no splashing or jet mixing that could cause foaming.

Monoclonal Antbody product filling can be complicated by high viscosities and sensitivity (shear, temperature, light, foaming). The Syn-Fill system mitigates these factors by performing a gentle filling operation using positive displacement that by virtue of its design is low shear and amenable to high viscosity liquids, ability to operate in cold rooms, fully automated filling can be done quickly <2hr with light protection, and filling includes no splashing or jet mixing that could cause foaming.

Antibody Drug Conjugates are often highly toxic and require special handling to ensure operator safety. The closed processing with pre-use integrity testing and fully automated operation of the Syn-Fill™ system ensures the utmost protection for your operators and the product quality.