INJECTABLE DRUG DELIVERY SOLUTIONS

• cGMP Aseptic Manufacturing And Sterile Fill-Finish

  Experienced CDMOs will implement a cGMP aseptic manufacturing and sterile fill-finish policy to improve drug bioavailability. Aseptic fill-finish is a process in which the drug product, container, and container closure are sterilized separately and then integrated. Combining the drug, container, and closure in a clean room using special equipment that is self-contained in a sterile environment meets FDA guidelines related to cGMP.

• 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.

• Pre-Filled Precision In Every Dose

  More than a service provider, we act as an extension of your team, accelerating your drug’s journey from late-stage clinical development to commercial supply.

• Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials

  Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges.

• Injection Molding

  Capabilities that improve efficiency and accelerate development.

  B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.

• Aidaptus® Manufacturing

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

• Non-Viral Gene Delivery (NVGD) Using Polymeric-Nano Particles

  Examine a NVGD platform that tackles the primary obstacle hindering gene editing therapies: efficient delivery. Utilizing engineered nanoparticles, the platform overcomes limitations associated with payload size.

• Pharmaceutical Development

  Developing an optimized formulation tailored to your API nanoparticles is critical to unlocking their full potential.

• Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials Of Insoluble Drugs

  Ascendia’s team of scientists have decades of combined experience in sterile supplies for clinical trials, making them expert at solving the most difficult formulation challenges. In short, we consistently make the insoluble soluble.

• Proven Vial Containment That Scales From R&D To Commercial

  Speed up your time to market and reduce your risk of selecting individual components that may not work well together by choosing the Ready Pack containment solution.