INJECTABLE DRUG DELIVERY SOLUTIONS

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Committed To Quality, Collaboration, Service And Innovation

  West is a leading global manufacturer in the design and production of technologically advanced, high quality, integrated containment and delivery systems for injectable medicines. We are a trusted partner to the world’s top pharmaceutical and biotechnology companies—working by their side to improve patient health.

• 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.

• Aseptic Filling System For Pharmaceuticals: BI-MI

  Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.

• 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.