INJECTABLE DRUG DELIVERY SOLUTIONS

• 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.

• Battelle: 90 Years Of Innovation

  Battelle, a leading nonprofit in applied science and technology, drives innovation in national security, healthcare, environment, and education while managing research labs and advancing critical discoveries.

• 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.

• Streamlining The Generic Combination Device Design Assessment Process

  A new six-phase assessment process simplifies regulatory approval for generic drug-device combination products, reducing costs and timelines while maintaining safety, effectiveness, and substitutability with reference-listed drugs.

• Formulations For Poorly Soluble And Low Bioavailability Drugs

  Ascendia specializes in the development of market suitable formulations for poorly water soluble drug substances. Based on the pre-formulation data package and the delivery requirements for the product, we recommend a comprehensive formulation development strategy. We understand that each formulation is unique and must address the specific challenges associated with poor solubility, inadequate bioavailability, and/or unacceptable physical/chemical stability. We also understand the urgency companies have for progressing their pipeline, and our approach maximizes the probability of success by exploring multiple formulation options in parallel if necessary.

• 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.

• 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.

• Pharmaceutical Vial Filling Machine With Isolator

  Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.

• Pharmaceutical Vial Filling Equipment: VFM

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

• 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.