When AST came to the table on the design for our new fill-finish isolator, one of the first areas AST engineers wanted to address was the usability and accessibility of the isolator and corresponding operations. With our customers’ point of view in mind, we wanted to address specific points of friction routinely encountered by operators and closely examine whether those friction points were necessary.

Does an isolator need to be ergonomically unfriendly to clean?

Should simple mechanisms like isolator doors be challenging to engage? (As much as one can appreciate exercise, no one wants to do “arm day” in cleanroom coveralls).

Does routine maintenance have to be time-consuming and laborious?

Many of these factors are accepted as par for the course in aseptic fill-finish manufacturing. Our question was, why?

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.

AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.

The needs of the pharmaceutical and biotechnology markets evolve rapidly as new breakthroughs in medical and pharmaceutical sciences allow the industry to improve treatments and outcomes. With these advances come opportunities to improve traditional processes that are stressed and proving inadequate in many cases to produce the next wave of patient-focused medicines.

Having the right balance of capacity and capabilities in all market conditions is the struggle that Contract Manufacturer Organizations face daily. Add to it the cost and complexity of maintaining a suitable parenteral manufacturing facility, the risks can be high. With constantly evolving parenteral market needs, having flexibility while achieving high utilization is key to long term success. To support these challenges, AST’s line of aseptic and syringe filling and closing machines provide adaptive fill-finish capabilities to ensure that any contract manufacturing organization has the right capabilities for any vial, syringe filling or cartridge application.

Pharmaceutical companies, researchers, scientists, and medical professionals work tirelessly to create and bring crucial vaccines and immunizations to the market. Understanding key product characterization details such as sterilization, secure packaging and optimal process conditions for manufacturing are necessary elements of the vaccine development process. The right vaccine development machines and filling equipment minimize obstacles to gaining this poduct and process knowledge. To aid the vaccine development process, AST’s vaccine filling machine, GENiSYS^®C allows scientists and pharmaceutical companies to differentiate their vaccine product and develop data-driven manufacturing processes in more meaningful and scalable ways.

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.

Cell and gene therapies have increased in popularity in recent years, and thanks to their ability to provide one-time treatments these therapies will play a significant role in treating some of the world's most challenging diseases. These drug products treat patients afflicted with genetic disorders and cancers by targeting the source of disease and altering its genetic makeup to eliminate its cause or symptoms. These therapies are expensive and complex and have been proven effective in numerous cases, but they present a challenge in producing them at scale and at a reasonable cost.

With many of the blockbuster biologic drugs of the ’90s are coming off of patent, companies are racing to provide a clinically similar alternative to these pioneering products. Like any biologic drug, they require care and attentiveness throughout the manufacturing process. Therefore, it is necessary to maintain aseptic conditions throughout the production process of these drug products.

AST’s GENiSYS® and semi-automated systems allow scientists and engineers to characterize their drug product and develop data-driven manufacturing processes in more meaningful and scalable ways.

AST provides dependable aseptic filling equipment proven within the pharmaceutical industry, but right-sized for the unique requirements of the compounding pharmacy environment.

AST aseptic filling products address the unique processing requirements to gently care for biologic products during the fill-finish process.

AST's GENiSYS® aseptic filling and closing machine has an innovative dosing system that ensures that each container processed has the exact amount of drug within the container.

AST’s GENiSYS® and ASEPTiCell® aseptic filling and closing systems have innovative capabilities that maximize product yield and product quality.

AST's line of aseptic and syringe filling and closing machines provide adaptive fill-finish capabilities to ensure that any contract manufacturing organization has the right capabilities for any vial, syringe or cartridge application.

AST machines are specifically designed so that your bioligics are handled with care and monitored closely.

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.

Today’s injectable drug products require flexible fill/finish systems that can efficiently process medium-sized clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.

AST’s GENiSYS® C is an advanced, yet compact, filling and closing system for automated processing of nested, custom and ready-to-use vials, syringes, and cartridges. With many features typically found in large scale filling machines, the GENiSYS C’s compact footprint makes this system ideal for use in small scale filling applications, including R&D, process development, engineering runs, niche product manufacturing, and even cGMP clinical and small-batch commercial manufacturing.

GENiSYS R has a unique blend of automated capabilities to ensure your sterile products, whether clinical or commercial, are processed in strict accordance with cGMP requirements. The system has the flexibility to adapt to your process requirements and container options alike. Its ability to process all ready-to-fill vial, syringe, and cartridge formats allows you to bring drug products to market cost-effectively.

AST’s line of table-top machines, GENiSYS® Lab, are ideal systems for drug product development and cGMP production applications. Each system is designed to automate the critical aseptic operations for vial, syringe and cartridge processing to reduce contamination risk and product variability. These table-top systems are engineered to have complete compatibility with cleanroom environments, including Laminar Air Flow Hoods, Bio-Safety Cabinets and aseptic isolators.

AST’s Container Closing System (CCS) is a benchtop, semi-automatic machine that provides complete and accurate control of the syringe and cartridge closing process. The Container Closing System is able to close syringes or cartridges using both vacuum and vent-tube methods for a wide range of container sizes quickly and easily with only a few format part changes.

AST’s Container Filling System (CFS) is a bench-top, semi-automatic machine used for the filling of pre-filled syringes and cartridges, and the filling and stoppering of vials and bottles. The system is designed to meet the demanding requirements for small batch processing of sterile injectable products.

AST's Vial Sealing System (VSS) is a benchtop, semi-automatic machine used for sealing or capping pharmaceutical vials and bottles with aluminum caps. The VSS provides complete and precise control of the container sealing or capping operations to ensure the highest quality vial seal. The system’s versatility allows for the processing of a wide range of vial or bottle sizes and finishes and is ideal for small batch processing of sterile pharmaceutical and biotechnology products.