ABOUT AST

Since 1965, AST has been delivering innovative solutions – many of which were industry firsts and have since become industry standards. AST has always understood that our customers serve demanding and oftentimes unpredictable markets. We also understand that “flexibility is the antidote to uncertainty,” and as your partner, AST consistently seeks to deliver innovative solutions that are robust, yet flexible. AST is a technology leader specializing in advanced aseptic filling and closing systems. Our focus is to provide innovative and flexible products that satisfy the most challenging product and regulatory requirements for the Pharmaceutical and Biotechnology industries. AST’s spectrum of products includes semi-automated to completely automated and integrated cGMP manufacturing systems for processing vials, syringes and cartridges. To discover more about our products please select a product category.

FEATURED PRODUCTS

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.

CONTACT INFORMATION

AST

4110 South Washington Street

Tacoma, WA 98409

UNITED STATES

Phone: 253-475-0200

Contact: Brittany Cooksey

FEATURED ARTICLES

  • CURIS System, an innovator in advanced decontamination technology, and AST, a leader in aseptic fill-finish processing technology, today announced a groundbreaking partnership. This collaboration marks a significant step forward in the pharmaceutical manufacturing industry, as the two companies combine technology to revolutionize the biodecontamination of aseptic fill-finish isolators using CURIS's disruptive vapor decontamination technology.

  • AST has over 50 years of experience designing, manufacturing, and servicing innovative, high quality and highly automated processing equipment. Beginning in 2006, AST leveraged our experience and close customer relationships to revolutionize the aseptic fill/finish industry with the launch of the ASEPTiCell® development.

  • The path to a successful life science startup is exciting, difficult, and unpredictable. Recent years have seen a volatile pattern emerge of challenge, change and innovation within the life sciences.

  • Aseptic fill-finish professionals are continually looking to augment their approach to a market that continues to grow and reflect innovations happening around sterile parenteral treatments.

  • Establishing early and clear tech transfer strategies is a key component of a holistic approach to drug development. Learn about the role that capable fill-finish solutions play in this process.

  • One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Explore the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

  • Germfree Laboratories, a global leader in isolator technology for aseptic processing and containment in the pharmaceutical sector, and AST, a pioneer in aseptic fill-finish processing technology, are thrilled to announce a revolutionary partnership. This landmark collaboration is set to redefine industry standards, launching a new era of innovation and efficiency.

  • Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.

  • Explore best aseptic practices for cell and gene therapy production that will be foundational to the ongoing development of these therapies as well as their successful manufacturing operations.

  • The rapid rise of highly targeted cell and gene treatments requiring small batch production necessitates a new path forward for biologics manufacturing and directly impacts the CMO/CDMO landscape.

  • When selecting an aseptic fill/finish machine, the choice to use a gloved or gloveless isolator will arise. To help with that decision, here are a few attributes to consider.

  • With regulatory requirements and GMP recommendations trending towards less human interaction and more robotic automation, robotics is the way of the future for the ATMP industry.

  • It's essential to understand how scaling up is affecting your aseptic filling operations. Here are four topics to consider to help ensure your drug product will be taken care of and ready for production.

  • Cell and gene therapies continue to gain significant traction in the biopharmaceutical world. While this technology continues to grow, challenges will inevitably follow. Explore considerations for aseptic fill/finish challenges.

  • The reason for the existence of the pharmaceutical world is simple – People need medicine. How you get that medicine to the patient is the big question. While many different facets of medicine were brought to light by the COVID-19 pandemic, possibly none were viewed as more important than the need for increased urgency when dealing with medicine that can save the life of a patient in need.

  • Small-scale aseptic filling presents a unique set of challenges. Learn what to look for when evaluating small-scale aseptic filling technology.

  • Automated Systems of Tacoma, LLC (AST), a leading provider of flexible aseptic filling systems, announces Josh Russell has rejoined AST as the Vice President of Sales & Marketing. Josh lives in Philadelphia, PA region and rejoins the AST team after three years at AES Clean Technologies as VP of Sales & Marketing. Previously, Josh worked at AST over a fifteen-year span holding several positions of responsibility including leading the development of AST’s fill-finish systems product line, and later as Vice President of Business Development.

  • The current and future wave of pharmaceutical and biotechnology products is making historical aseptic filling machine manufacturing methodologies inadequate and antiquated. Traditional production processes used for high-volume drug products are stressed to efficiently meet the production requirements of targeted medicines that dominate today’s clinical pipelines.

  • AST, a leading provider of flexible aseptic filling systems, announces they are now offering delivery of their most popular isolated equipment within 6 months of purchase. This is a dramatic improvement over typical industry delivery times, which are often up to 24 months. AST knows that time to market is critical in delivering drug products to sick patients, and quick delivery demonstrates their commitment to reducing the time it takes to provide critical treatments.

  • AST is excited to exhibit at Achema this month, August 22-26 in Frankfurt, Germany. Keith Dodson, Vice President of Global Business Development at AST, will be in Hall 3.1 Booth B32 To schedule a meeting with Keith Dodson during the show, reach out at https://www.ast-inc.com/contact-us/.

AST VIDEOS

  • Watch as Josh Russell, VP of Sales and Marketing, AST, demonstrates the GENiSYS® C aseptic filling system, ideal for use in small-scale filling applications.

  • Josh Russell, VP of Sales & Marketing, describes the AST Quick Delivery program, which makes certain isolated fill finish equipment available within six months of purchase.

  • Join Keith Dodson of Automated Systems to discover small batch aseptic solutions for cell therapy, gene therapy, vaccines, R&D, biosimilars and CDMO’s.

  • The AST GENiSYS R provides ultimate flexibility for the aseptic filling of liquid pharmaceuticals. Designed with the specific challenges of small-batch production in mind, the GENiSYS R can be built to meet the needs of your facility today and for years to come. Learn more in our latest video.

  • The 4th generation GENiSYS C is an advanced yet compact solution for automated aseptic processing of liquid pharmaceutical products, with many features typically reserved for large scale filling lines. Learn more in our latest video.

  • ASEPTiCell provides flexible, robotic filling and finishing of vials, syringes and cartridges for small to medium clinical and commercial batches. The modular design allows the ASEPTiCell to be built to your specification without the cost and risk of customization.

  • The GENiSYS® R offers a unique blend of automated capabilities to ensure your sterile products are processed in strict accordance with cGMP requirements. With robotic handling available from bag opening to vial sealing, and integration with barrier technologies, your product is protected from contamination through all stages of processing. 

  • GENiSYS® R provides ultimate flexibility for processing ready-to-use vials, syringes and cartridges on a single machine. Highly reliable robotics and recipe driven changeovers allow for complete format changes in as little as 30 minutes. Maximize productivity and return-on-investment with the GENiSYS R.

  • AST’s GENiSYS® Lab semi-automatic systems are ideal for drug product development and cGMP production applications. Each system automates the critical aseptic operations for vial, syringe and cartridge processing to reduce contamination risk and product variability. GENiSYS Lab offers a perfect balance between automated features, size and affordability without compromising quality, safety and ease of use.

  • Is the general opinion about robotics improving? Watch this webinar to learn more about where and how robotics add value and solve problems.  

  • This presentation addresses the changing needs for the manufacturing of biologics and the rationale for the use of robotics and automation in aseptic fill and finish processing of these products.