Advancing Aseptic Processing
The current and future wave of pharmaceutical and biotechnology products has quickly made the historical practice and aseptic manufacturing methodologies inadequate and antiquated. The solutions used for the blockbuster products of the last decade are stressed to meet the challenges of patient focused gene and cell therapies that dominate today’s clinical pipelines. To address the production and quality requirements these niche products demand, the traditional aseptic production processes had to be rethought and redeveloped. Recognizing these trends AST developed technically advanced aseptic filling systems, dedicated to provide flexible and efficient production of sterile injectables.
AST’s ASEPTiCell and GENiSYS product lines integrate industry proven technologies such as robotics and isolator-barrier technology that provide flexible aseptic filling and closing of ready-to-fill vials, syringes and cartridges. AST’s innovative designs provide this range of flexibility with adaptive robot technology. There’s no need to dock process module or trolleys to the system to process each container, making AST’s solution a truly flexible option that is simple and more cost competitive.
AST’s broad spectrum of aseptic filling system options provides multiple solutions for drug product manufacturing from development activities in the lab to production options at the plant.
Our lab and bench scale production systems, like the GENiSYS system, allow for automated filling and closing operations for R&D and small scale production processes. The system is so compact that fitting into small lab, clean spaces, or even laminar airflow hoods is not a problem.
The ASEPTiCell is a cGMP production focused solution that is modular in nature with pre-engineered process modules that can be easily configured to quickly deliver a fully automated, “no-touch”, turnkey aseptic production machine. With the integration of isolator-barrier technology the ASEPTiCell can process potent products like cytotoxics and Anti-body Drug Conjugates (ADCs).
If you are looking for a flexible and technically advanced solution to your aseptic filling application AST has the right solutions. Explore our products below to learn more.
- Small to medium batch manufacturing of clinical and commercial products
- Gentle handling and processing of biologics, proteins and cell therapies
- Processing of potent and cytotoxic products
- R&D, process development, scale-up and tech transfer of aseptic processes
- 503b Compounding Pharmacies
- Reduced facility space and utility requirements
- Flexible production platform for processing ready-to-fill vials, syringes and vials
- Simple system design reduces cleaning and changeover time
- Integration with isolator-barrier technology maximizes product and patient safety
- Broad spectrum of products that meet the unique requirements of the drug development lifecycle, from R&D to commercialization
- Powerful data collection system provides process intelligence necessary to optimize every step in the aseptic process