INJECTABLE DRUG DELIVERY SOLUTIONS

• 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.

• Pharmaceutical Vial Filling Equipment: VFM

  VFM automatic filling and stoppering machines are designed for injectable solutions in vials.

• A Comprehensive Approach That's Exceptional By Design

  An overview of analytical capabilities to boost product quality, meet regulatory expectations, and drive development through phase‑appropriate methods and specialized testing for complex drug programs.

• Sterile Drug Product

  Accelerate sterile injectable development with expert support, advanced facilities, and tailored solutions for complex APIs — from formulation through commercialization across small molecules and biologics.

• BD Neopak™ XtraFlow™ Glass Prefillable Syringe

  A next‑generation injectable system uses shorter, thinner needles to reduce injection risk, lower force and time requirements, and improve comfort and usability for administering viscous formulations.

• Daikyo Crystal Zenith® Ready-To-Use Nested Vials

  West presents Crystal Zenith vials in a nested packaging configuration, designed to meet the exterior dimensions of glass standard ISO 8362-1.

• Medical Device Technical Due Diligence

  By partnering with Battelle, your organization can reduce risks and save on investment costs, leading to more successful and sustainable outcomes.

• What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?

  As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.

• 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.

• 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.