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.

• Meet The Demands Of Today To Help Ensure The Possibility Of Tomorrow

  Emergency‑readiness programs strengthen response with dependable countermeasures, rapid‑action tools, and decades of expertise supporting teams facing chemical, biological, and other high‑risk threats.

• 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.

• Prefilled Syringe Plungers: Mitigate Against Risks To Improve Success

  From start to finish, NovaPure components have been designed and manufactured using Quality by Design principles to mitigate risk for the patient.

• Battelle's Chemistry Technical Center (CTC)

  Integrated formulation, analytical, and bioanalytical capabilities plus advanced facilities tackle complex chemistry, delivering accurate data, regulatory confidence, and smooth study progression.

• Robotic Multi-Format Filling & Closing System

  AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

• 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.

• 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.

• Automated Vision Inspection Systems For Injectable Drug Products: Vials, Syringes, Cartridges, Bottles

  We offer a comprehensive range of automatic inspection machines for injectable pharmaceutical products contained in ampoules, vials, cartridges, syringes and bottles. Designed and manufactured to meet the most demanding technical requirements, our solutions feature different production speeds and advanced vision standards for an optimum performance.

• Isolator Barrier Pharmaceutical Aseptic Filling Systems

  ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.