INJECTABLE DRUG DELIVERY SOLUTIONS

• Pharmaceutical Aseptic Filling Equipment

  AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.

• Unlocking The Potential Of Your Sterile Injectable

  Learn how a CDMO with robust processes and specialized technologies like automated fill lines can help you speed to market while maintaining consistently high quality of your product.

• Aseptic Filling Systems For Biopharmaceutical Manufacturing

  AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell^® and GENiSYS^® systems. AST has experience dosing products at temperatures as low as 3°C.

• Aidaptus® Manufacturing

  We are the exclusive manufacturing partner for this innovative auto-injector platform.

• Analytical Services

  As part of Stevanato Group’s commitment to R&D, our analytical testing sites focus on investigating the physico-chemical properties and interactions of primary packaging materials and drug products.

• GENiSYS® C Multi-Format Filling and Closing Machine

  AST’s GENiSYS® C is an advanced, yet compact, filling and closing system for automated processing of nested, custom and ready-to-use vials, syringes, and cartridges. With many features typically found in large scale filling machines, the GENiSYS C’s compact footprint makes this system ideal for use in small scale filling applications, including R&D, process development, engineering runs, niche product manufacturing, and even cGMP clinical and small-batch commercial manufacturing.

• Drug Product Services: Pre-Formulation To Commercial-Scale Production

  Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.

• Aseptic Manufacturing Services

  Our system is ideally suited for the production of pre-clinical, clinical and niche commercial injectable products in vial, syringe, and cartridge formats.

• Small, Simple-To-Use Package For Delivering High-Viscosity Formulations

  Subcutaneous

  Low - Medium Viscosities
  < 100 cP
  1 - 10 ml

  High - Ultra-High Viscosities
  >100 - 10,000 cP
  0.5 - 3 ml

  ArQ^® - Bios offers a small, simple to use package to deliver high viscosity formulations. Oval’s proprietary COC PDC technology allows us to build the device around a stronger drug container that can deliver 1ml of formulations up to 1000cP through a 25G needle in  less than 5 seconds. The ArQ-Bios  platform  also can deliver  greater volumes than 1 ml subject to matching  the formulation characteristics with acceptable patient tolerability.

• Better Solutions For Your Drug Product

  With world-class facilities, the state-of-the-art equipment and some of the industry’s most talented people, you can feel confident that your small molecule drug product is in safe hands. Learning from decades working with other small molecules, INCOG has been purpose-built to provide better solutions for the global injectable drug product sector.