PRODUCTS

GENiSYS® Lab: Tabletop Innovation for Aseptic Processing

AST’s GENiSYS® Lab series offers automated, flexible aseptic processing (container filling, container closing, and vial sealing). The key advantage of these systems is that they were designed specifically for laboratory settings, configured with a tabletop technology that leverages precise automation for critical points in aseptic operation to lower overall risk and ensure the highest standards of product quality and data integrity from the very start of drug development. Each lab system is outfitted with an intuitive HMI on a portable tablet for centralized control of the operation, process parameters, and records. User-friendly operations utilize flexible recipe-driven production to meet the full scope of small-scale drug processing including research and development, process development and commercial production of highly targeted liquid pharmaceuticals. End-to-end process data collection is accurate, automated, and exportable. Additionally, each system can be upgraded with an Electronic Batch Record (EBR) system to provide 21 CFR Part 11 compliance.

As with all of AST’s solutions, each lab system is backed by a dedicated Customer Care team committed to the high performance of our equipment as long as it’s in the field.

In the Know

Capabilities

  • Proven and standardized tabletop solutions ideal for small-scale drug development
  • Universal RTU container processing capabilities
  • cGMP-proven design and technology
  • Scalable solutions featuring turnkey technology available on all our advanced systems
  • Easy validation and efficient technology transfer
  • Available with in-process controls for quality control and high-yield operations
  • Full ramp-up support including qualification services and full documentation packages
  • Responsive, 24/7 aftermarket support throughout the life of your equipment
  • Toolless change parts
  • Processes vials, syringes, and cartridges. Configurable, recipe-driven production and process monitoring.
  • Versatile, recipe-driven production
  • Centralized, remote HMI for operation and data retention, and optional EBR system for 21 CFR Part 11 Compliance

A question drug developers frequently revisit is what ways are available to make laboratory drug processing more efficient and effects . Automation is one avenue that continues to grow in application and potential for drug discovery and development. As important benchtop operations are in drug development journey, many laboratory settings still use primarily manual methods. Automated solutions  addressing address and correct the inefficiencies and obstacles associated with a manual-only approach, including human errors, contamination risks and incomplete data.  Automated lab technology provides clear improvements and advancements in these areas and more and offer improved efficacy for the entire drug development lifecycle.

Module by Module

Highlights:

  • Closes Cartridges and Syringes
  • Inert gas purging
  • Precise piston placement
  • Vacuum, Vent-tube or Combination stoppering
  • Available in two-up configuration
  • Multi-stage vacuum insertion available

Highlights:

  • Accurate dispense system
  • Process flexibility allows the system to fill
  • Inert gas purging during filling
  • Optional In Process Weight Check
  • Optional product bag with surge stand
  • Available with peristaltic or Rotary piston pumps
  • For vials: Stoppering with serum or lyo stopper or press-fit cap.

Highlights:

  • Provides aesthetic pharmaceutical-grade seal
  • Caps vials and bottles
  • Gentle, free-spinning disk sealing for lower particle generation
  • Eliminates crimp-style inconsistencies

You've seen the GENiSYS® Lab in motion...

Perhaps it's time to discover how it would work with your application?

Meeting Industry Needs | Applications

galvanizing research and development - genisys lab - applcations
Galvanizing Research and Development

Research and development is a critical undertaking for pharmaceutical manufacturers and is the backbone of the life sciences industry. Every lifesaving and life-improving treatment that has ever been produced started in a laboratory setting. Before a treatment can reach a patient in need, it’s in the laboratory that it’s discovered, refined, and then pushed forward to start its pre-clinical to commercial journey. 

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Stability Studies
Stability studies are crucial aspects of product development, and necessary quality control measures at frequent intervals during the drug manufacturing lifecycle. The GENiSYS® Lab systems provide scientists with the tools needed to examine and ensure shelf life for sterile parenteral products.
clinical trial manufacturing - genisys lab - applications
Clinical Trial Manufacturing
Clinical trials are an indispensable step in bringing a drug to market. The safety of patients is primary, and data integrity is crucial to continued development. GENiSYS® Lab systems offer accurate, repeatable filling and closing and can integrate with the latest in aseptic barrier technology.
optimizing for tech transfer from start - genisys lab - applications
Optimizing for Technology Transfer From the Start
Developing the drug products of tomorrow requires highly flexible solutions that translate to large-scale production. Each GENiSYS® Lab system provides recipe parameters, system features and servo control that accurately simulate mass production operations at a bench scale. Accessing, analyzing, and optimizing each process parameter is key to further development With proven, validated key technologies like pumps, decontamination methods, IPC protocols, and filling and closing methods able to transfer seamlessly from one state of drug development to the next, the need for revalidation is reduced, and valuable time is saved over the life of an operation.  AST’s automated approach allows for uncorrupted data traceability across the entire drug development progression, crucial for maintaining cGMP compliance and preserving process knowledge for successful technology transfers.

Use Cases

Cell Therapy Manufacturing

A global biomanufacturing company partnered with AST on an innovative, isolated GENiSYS® Lab systems for processing cell therapy products.

Download the Case Study